Substance Use DisordersPhase 2EDITORNCT06434818
Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders
A Phase 2 study testing EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance) and CBOT with olfactory stimulants & OFC tasks in people with Substance Use Disorders and Opioid Use Disorder, run by Evon Medics LLC at 3 sites in United States.
Trial summary
The overarching goal of this study phase, Phase II component is to implement Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in substance use disorder (SUD) clinics to demonstrate pilot effectiveness for SUD outcomes compared to treatment as usual… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Substance Use Disorders, Opioid Use Disorder, Alcohol Use Disorder
- What is being tested?
- EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance) and CBOT with olfactory stimulants & OFC tasks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Jul 2023to 30 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 80 years, inclusive at enrollment.
- Diagnosis of current moderate or severe substance use disorders, opioid use disorders, stimulant (cocaine and methamphetamine) use, and alcohol use disorders in the past three months, including the past month.
- Does not meet criteria for other current SUDs outside of the 3 above, except for mild or moderate use of cannabis
- Willing to receive study interventions and buprenorphine (for OUD group) and naltrexone (for AUD group) during the study
- Females must not be pregnant at enrollment and agree not to become pregnant during the trial, through scientifically valid ways of contraception
- Willing to sign the informed consent form.
- Have a stable place to stay and retain the EDITOR devices in a secure condition when receiving the intervention and during the entire duration of the study participation.
Who cannot join
- Any significant neurological disease such as stroke, dementia, meningitis, neurosyphilis, cerebral palsy, encephalitis, epilepsy, or seizures.
- Mental retardation.
- Presence of serious mental illness, such as schizophrenia, bipolar disorders, and suicidal risk. Diagnosis of major depressive disorders, anxiety disorders, and post-traumatic stress disorders (PTSD), will be included if symptoms are stable, with no suicidal ideas or plans, and there are no recent changes in treatment of these conditions in the 6 weeks prior to enrollment.
- Experiencing current suicide ideas or plans.
- Any unstable medical condition such as uncontrolled hypertension, uncontrolled diabetes, or liver cirrhosis as determined by the site PI.
- History of severe traumatic nose injury that affects the ability to smell or significant intranasal disease, as determined by the site PI.
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- Known allergies or intolerance to aromas from plant essential oils. E.g., orange and lemon.
- Breastfeeding or pregnancy test positive or plans to get pregnant in the 6 months following enrollment.
- Individuals who are on parole or probation.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Enrolling by invitation
Maryland Treatment Center
Rockville, Maryland, 20853
- Recruiting
Clinics of Dr. Edwin Chapman @ MHDG
Washington D.C., District of Columbia, 20002
Edwin Chapman, MD
- Recruiting
Howard University
Washington D.C., District of Columbia, 20060
Tanya Alim, MD
About this study
Official title: Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR)
The overarching goal of this study phase, Phase II component is to implement Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in substance use disorder (SUD) clinics to demonstrate pilot effectiveness for SUD outcomes compared to treatment as usual (TAU) and Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) device as active control. The investigators will conduct a multi-site study of 300 adult patients with opiate use disorder (OUD), stimulant (i.e., cocaine, methamphetamine) and/or alcohol use disorder (AUD) from community and clinics to evaluate whether EDITOR is associated with better patient treatment outcomes (e.g., retention in treatment and abstinence). The pilot study will provide preliminary data needed for design of a Phase III trial, including estimates of effect size. The investigators will also explore development of machine learning/AI algorithms integrating clinical and physiological data into treatment decision guides for providers.
Read the detailed description
The Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) is a project to develop a sustainable, scalable, and patient-centered mobile health platform, comprised of (1) a patient-facing culturally-adapted digital chemosensory therapeutic for stimulant, alcohol and opioid use disorders, sensors for acquisition of objective physiological measures of substance intoxication and withdrawal, and an application for running and interpreting the interventions and sensory acquisition programs; and (2) a provider-facing web portal, for substance use disorder treatment in socially disadvantaged and sexual minority populations.
The small business, Evon Medics implemented the use of the EDITOR device as a novel approach for remote management of substance use disorders (SUDs) amid the challenges of the COVID-19 pandemic. Management of SUD mostly involve direct contact between patients and providers, but the precedence of COVID-19 pandemic has elevated the need for patient-centered remote management of SUD. While digital therapeutics and mobile health platforms provide avenues for remote management, communities of African Americans (AA), Hispanic Americans (HA) and other socially disadvantaged populations lag in adoption of these mobile platforms, due to inability to read, digital illiteracy, lack of access to smartphones, absence of reliable Wi-Fi or internet, and financial constraints. Moreover, while interventions exist for OUD, there are no drugs for cocaine or stimulant use disorders. Underserved AA and HA communities with OUD, particularly marginalized men who have sex with men (MSM), have more severe co-existing cocaine, methamphetamine, and alcohol use disorders; and digital solutions for these populations are lacking. Providers on the other hand, lack well-adapted, intelligent-based physiological and psychophysical acquisition platforms to guide remote agonist management of opioid and alcohol withdrawal.
EVON Medics developed a combinatorial digital chemosensory-based orbitofrontal cortex training for Opioid Use Disorder (CBOT). Based on the limitations of CBOT for the socially disadvantaged AA, HA and MSM population, the investigators recently revised the platform for treatment of stimulant and alcohol use disorder, by including beta-caryophyllene chemosensory stimulation. Further product development, with innovative changes to the patient-facing platform and a new provider-facing platform to guide remote management of OUD, stimulant (cocaine and methamphetamine) use and alcohol use disorders were preliminary tested (Phase I) in affiliated substance use community programs and community populations in the under-served communities in Washington, DC and Maryland.
In this study phase, Phase II of this Fast-Track SBIR application, the investigators will conduct a pilot randomized trial of EDITOR compared to treatment as usual and CBOT for office-based treatment of SUDs in several federal funded programs associated with Evon Medics and Howard University, to assess EDITOR's effectiveness in improving treatment retention, reducing relapses, and mitigating SUD severity, and offering a promising solution for home-based SUD treatment.
- Conditions
- Substance Use Disorders, Opioid Use Disorder, Alcohol Use Disorder, Cocaine Use Disorder, Methamphetamine-dependence
- Being tested
- EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance), CBOT with olfactory stimulants & OFC tasks, CBOT Sham
- Keywords
- Substance Abuse, Substance Use Disorder, Retention, Relapse, Chemosensory-Based Olfactory Networks Training, Remote Management
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders, Alcoholism, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance)Combination product
Also called EDITOR plus Treatment-As-Usual (TAU)
EDITOR includes a user-friendly cloud portal synced with the main device, providing a comprehensive training program for the orbitofrontal cortex (OFC). The main device stimulates the orbitofrontal cortex intensely, preventing habituation to smells and improving adaptability. This enhances neurobehavioral plasticity, benefiting Substance Use Disorder (SUD) outcomes. The device also features a 60% beta-caryophyllene scent for addressing issues like Alcohol Use Disorder and stimulant use disorders. With ten digital enhancements, it enables remote treatment and data collection, seamlessly transmitting information to healthcare providers through a secure, HIPAA-compliant portal.
CBOT with olfactory stimulants & OFC tasksCombination product
Also called CBOT active plus TAU
The CBOT with proprietary odorant molecules is designed to stimulate olfactory neural activity over long periods of time combined with orbitofrontal cortex (OFC) dependent olfactory tasks.
CBOT ShamCombination product
Also called CBOT passive plus TAU
CBOT Sham uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive olfactory tasks
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Digital-Chemosensory-Based Olfactory Training (EDITOR) | Experimental | The EDITOR device is designed to stimulate intensive neural activity in OFC over long periods of time. It consists of 40 daily cycles of intervention with a combination of olfactory stimulation and training tasks, lasting ~45 minutes, delivered once daily over three months. The device also includes 60% beta-caryophyllene chemosensory stimulation to target AUD and stimulant use disorder and 10 digital enhancements for the purpose of remote treatment, remote acquisition of behavioral and physiological data, and seamless data transmission to providers, through a HIPAA-compliant clinic end portal.
Participants assigned to this arm will receive their treatment-as-usual (TAU) alongside daily EDITOR therapy for three months. TAU will depend on the drug abused [Buprenorphine with a median dose of 24 mg (range 16 - 32 mg) for Opioid use disorder and naltrexone (50-100 mg daily for Alcohol use disorder (AUD). Receives: Combination Product: EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance) |
| Chemosensory-Based Olfactory Training (CBOT) | Active comparator | CBOT with olfactory stimulants \& orbitofrontal (OFC) tasks
TAU same as above + CBOT (Chemosensory-Based Olfactory Training) therapy (40 cycles of olfactory stimulation and OFC training tasks, lasting ~45 minutes, once daily over three months) + use of their smartphone to communicate with their clinic provider/staff Receives: Combination Product: CBOT with olfactory stimulants & OFC tasks |
| Chemosensory-Based Olfactory Training (CBOT) Sham | Sham comparator | Control Device (Sham) is CBOT device without olfactory stimulants and orbitofrontal tasks.
TAU same as above + CBOT sham + use of their smartphone to communicate with their clinic provider/staff. This CBOT device uses compressed room air scented with phenylethylamine (rose scent) instead of olfactory stimulants and has shape pattern matching tasks instead of cognitive tasks in order to blind users to their treatment assignment. Similar to the active arm, sham COT will be used daily for 45 minutes. Receives: Combination Product: CBOT Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in SUD treatment
3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine.
Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
Measured: Baseline to day 14
Retention in SUD treatment
3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine.
Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
Measured: Baseline to day 28
Retention in SUD treatment
3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine.
Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
Measured: Baseline to 8 weeks
Retention in SUD treatment
3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine.
Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
Measured: Baseline to three months
SUD Relapse Rate
Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through:
- survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and
- biochemical verification of drug use from urine samples collected and tested every two weeks.
Measured: Baseline to day 7
SUD Relapse Rate
Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through:
- survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and
- biochemical verification of drug use from urine samples collected and tested every two weeks.
Measured: Baseline to day 14
SUD Relapse Rate
Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through:
- survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and
- biochemical verification of drug use from urine samples collected and tested every two weeks.
Measured: Baseline to day 28
SUD Relapse Rate
Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through:
- survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and
- biochemical verification of drug use from urine samples collected and tested every two weeks.
Measured: Baseline to 8 weeks
SUD Relapse Rate
Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates.
Ascertainment of relapse is through:
- survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and
- biochemical verification of drug use from urine samples collected and tested every two weeks.
Measured: Baseline to three months
SUD engagement
SUD engagement is the proportion of people treated at baseline who complete the first two weeks of treatment.
Measured: Baseline to day 14
Secondary outcomes (28)
Opioid Craving Scale (OCS)
Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates).
Measured: Baseline to Day 7
Cocaine Craving Questionnaire-Brief (CCQ-Brief)
Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving.
Measured: Baseline to day 7
Self-report instruments for Alcohol Craving
Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?"
Measured: Baseline to day 7
Subjective Opioid Withdrawal Scale (SOWS)
Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).
Measured: Baseline to day 7
Positive and Negative Affect Scales (PANAS)
Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
Measured: Baseline to day 7
Opioid Craving Scale (OCS)
Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates).
Measured: Baseline to day 14
Cocaine Craving Questionnaire-Brief (CCQ-Brief)
Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving.
Measured: Baseline to day 14
Self-report instruments for Alcohol Craving
Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?"
Measured: Baseline to day 14
Subjective Opioid Withdrawal Scale (SOWS)
Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).
Measured: Baseline to day 14
Positive and Negative Affect Scales (PANAS)
Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
Measured: Baseline to day 14
Opioid Craving Scale (OCS)
Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates).
Measured: Baseline to Day 28
Cocaine Craving Questionnaire-Brief (CCQ-Brief)
Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving.
Measured: Baseline to day 28
Self-report instruments for Alcohol Craving
Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?"
Measured: Baseline to day 28
Subjective Opioid Withdrawal Scale (SOWS)
Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).
Measured: Baseline to day 28
Positive and Negative Affect Scales (PANAS)
Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
Measured: Baseline to day 28
Addiction Severity Index (ASI)
Monthly severity of opioid, stimulants and alcohol use using the ASI-modified
The ASI is an assessment tool used to gauge the severity of a person's substance abuse and provides a comprehensive overview of a person's addiction-related issues. It addresses seven (7) main aspects of a person's behavior and environment. The areas assessed include medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status.
The ASI substance abuse assessment uses the composite score to assign a severity rating. The ratings are based on a scale of 0 to 9 as follows:
0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital.
Measured: Baseline to day 28
Opioid Craving Scale (OCS)
Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates).
Measured: Baseline to 8 weeks
Cocaine Craving Questionnaire-Brief (CCQ-Brief)
Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving.
Measured: Baseline to 8 weeks
Self-report instruments for Alcohol Craving
Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?"
Measured: Baseline to 8 weeks
Subjective Opioid Withdrawal Scale (SOWS)
Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).
Measured: Baseline to 8 weeks
Positive and Negative Affect Scales (PANAS)
Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
Measured: Baseline to 8 weeks
Addiction Severity Index (ASI)
Monthly severity of opioid, stimulants and alcohol use using the ASI-modified
The ASI is an assessment tool used to gauge the severity of a person's substance abuse and provides a comprehensive overview of a person's addiction-related issues. It addresses seven (7) main aspects of a person's behavior and environment. The areas assessed include medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status.
The ASI substance abuse assessment uses the composite score to assign a severity rating. The ratings are based on a scale of 0 to 9 as follows:
0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital.
Measured: Baseline to 8 weeks
Opioid Craving Scale (OCS)
Change in pre- and post- intervention changes using OCS
The Opioid Craving Scale is used to measure opioid craving. The scale consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates).
Measured: Baseline to three months
Cocaine Craving Questionnaire-Brief (CCQ-Brief)
Change in pre- and post- intervention changes using CCQ-Brief
The Cocaine Craving Questionnaire-Brief (CCQ-Brief) consists of 10 statements about the respondent's feelings and thoughts about using cocaine as her or she is completing the questionnaire (i.e., right now). This instrument allows investigators to obtain a reflection of the respondent's general cocaine craving.
Measured: Baseline to three months
Self-report instruments for Alcohol Craving
Change in pre- and post- intervention changes using self-report instruments for alcohol craving
Administration of a single-item instrument on which the participant reports his or her level of subjective craving. These instruments include questions such as "How strong is your craving for alcohol?" or "How strong is your urge to drink?"
Measured: Baseline to three months
Subjective Opioid Withdrawal Scale (SOWS)
Change in pre- and post- intervention changes using SOWS
The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).
Measured: Baseline to three months
Positive and Negative Affect Scales (PANAS)
Change in severity of negative affect scores from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
Measured: Baseline to three months
Addiction Severity Index (ASI)
Monthly severity of opioid, stimulants and alcohol use using the ASI-modified
The ASI is an assessment tool used to gauge the severity of a person's substance abuse and provides a comprehensive overview of a person's addiction-related issues. It addresses seven (7) main aspects of a person's behavior and environment. The areas assessed include medical status, employment and support, drug use, alcohol use, legal status, family/social status, and psychiatric status.
The ASI substance abuse assessment uses the composite score to assign a severity rating. The ratings are based on a scale of 0 to 9 as follows:
0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital.
Measured: Baseline to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start7 Jul 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evon Medics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Howard University, Maryland Treatment Centers, Inc., Clinics of Dr. Edwin Chapman, MD, PC @ MHDG, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Charles Nwaokobia, Principal investigator, Evon Medics LLCEvaristus Nwulia, MD, Principal investigator, Evon Medics LLCTanya Alim, MD, Principal investigator, Howard UniversityEdwin Chapman, MD, Principal investigator, Clinics of Dr. Edwin Chapman at MHDGMarc Fishman, MD, Principal investigator, Maryland Treatment Centers, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434818
- Sponsor's protocol ID
- EDITDA056156
- Other IDs
- 4R44DA056156-02
- Acronym
- EDITOR
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR)
- ClinicalTrials.gov ID
- NCT06434818
- Acronym / sponsor ID
- EDITOR / EDITDA056156
- Conditions
- Substance Use Disorders, Opioid Use Disorder, Alcohol Use Disorder, Cocaine Use Disorder, Methamphetamine-dependence
- Keywords
- Substance Abuse, Substance Use Disorder, Retention, Relapse, Chemosensory-Based Olfactory Networks Training, Remote Management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Evon Medics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Howard University, Maryland Treatment Centers, Inc., Clinics of Dr. Edwin Chapman, MD, PC @ MHDG, National Institute on Drug Abuse (NIDA)
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of this study phase, Phase II component is to implement Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in substance use disorder (SUD) clinics to demonstrate pilot effectiveness for SUD outcomes compared to treatment as usual (TAU) and Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) device as active control. The investigators will conduct a multi-site study of 300 adult patients with opiate use disorder (OUD), stimulant (i.e., cocaine, methamphetamine) and/or alcohol use disorder (AUD) from community and clinics to evaluate whether EDITOR is associated with better patient treatment outcomes (e.g., retention in treatment and abstinence). The pilot study will provide preliminary data needed for design of a Phase III trial, including estimates of effect size. The investigators will also explore development of machine learning/AI algorithms integrating clinical and physiological data into treatment decision guides for providers.
Detailed description
The Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) is a project to develop a sustainable, scalable, and patient-centered mobile health platform, comprised of (1) a patient-facing culturally-adapted digital chemosensory therapeutic for stimulant, alcohol and opioid use disorders, sensors for acquisition of objective physiological measures of substance intoxication and withdrawal, and an application for running and interpreting the interventions and sensory acquisition programs; and (2) a provider-facing web portal, for substance use disorder treatment in socially disadvantaged and sexual minority populations.
The small business, Evon Medics implemented the use of the EDITOR device as a novel approach for remote management of substance use disorders (SUDs) amid the challenges of the COVID-19 pandemic. Management of SUD mostly involve direct contact between patients and providers, but the precedence of COVID-19 pandemic has elevated the need for patient-centered remote management of SUD. While digital therapeutics and mobile health platforms provide avenues for remote management, communities of African Americans (AA), Hispanic Americans (HA) and other socially disadvantaged populations lag in adoption of these mobile platforms, due to inability to read, digital illiteracy, lack of access to smartphones, absence of reliable Wi-Fi or internet, and financial constraints. Moreover, while interventions exist for OUD, there are no drugs for cocaine or stimulant use disorders. Underserved AA and HA communities with OUD, particularly marginalized men who have sex with men (MSM), have more severe co-existing cocaine, methamphetamine, and alcohol use disorders; and digital solutions for these populations are lacking. Providers on the other hand, lack well-adapted, intelligent-based physiological and psychophysical acquisition platforms to guide remote agonist management of opioid and alcohol withdrawal.
EVON Medics developed a combinatorial digital chemosensory-based orbitofrontal cortex training for Opioid Use Disorder (CBOT). Based on the limitations of CBOT for the socially disadvantaged AA, HA and MSM population, the investigators recently revised the platform for treatment of stimulant and alcohol use disorder, by including beta-caryophyllene chemosensory stimulation. Further product development, with innovative changes to the patient-facing platform and a new provider-facing platform to guide remote management of OUD, stimulant (cocaine and methamphetamine) use and alcohol use disorders were preliminary tested (Phase I) in affiliated substance use community programs and community populations in the under-served communities in Washington, DC and Maryland.
In this study phase, Phase II of this Fast-Track SBIR application, the investigators will conduct a pilot randomized trial of EDITOR compared to treatment as usual and CBOT for office-based treatment of SUDs in several federal funded programs associated with Evon Medics and Howard University, to assess EDITOR's effectiveness in improving treatment retention, reducing relapses, and mitigating SUD severity, and offering a promising solution for home-based SUD treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enhanced Digital-Chemosensory-Based Olfactory Training (EDITOR) | Experimental | Combination Product: EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance)The EDITOR device is designed to stimulate intensive neural activity in OFC over long periods of time. It consists of 40 daily cycles of intervention with a combination of olfactory stimulation and training tasks, lasting ~45 minutes, delivered once daily over three months. The device also includes 60% beta-caryophyllene chemosensory stimulation to target AUD and stimulant use disorder and 10 digital enhancements for the purpose of remote treatment, remote acquisition of behavioral and physiological data, and seamless data transmission to providers, through a HIPAA-compliant clinic end portal. Participants assigned to this arm will receive their treatment-as-usual (TAU) alongside daily EDITOR therapy for three months. TAU will depend on the drug abused [Buprenorphine with a median dose of 24 mg (range 16 - 32 mg) for Opioid use disorder and naltrexone (50-100 mg daily for Alcohol use disorder (AUD). |
| Chemosensory-Based Olfactory Training (CBOT) | Active comparator | Combination Product: CBOT with olfactory stimulants & OFC tasksCBOT with olfactory stimulants \& orbitofrontal (OFC) tasks TAU same as above + CBOT (Chemosensory-Based Olfactory Training) therapy (40 cycles of olfactory stimulation and OFC training tasks, lasting ~45 minutes, once daily over three months) + use of their smartphone to communicate with their clinic provider/staff |
| Chemosensory-Based Olfactory Training (CBOT) Sham | Sham comparator | Combination Product: CBOT ShamControl Device (Sham) is CBOT device without olfactory stimulants and orbitofrontal tasks. TAU same as above + CBOT sham + use of their smartphone to communicate with their clinic provider/staff. This CBOT device uses compressed room air scented with phenylethylamine (rose scent) instead of olfactory stimulants and has shape pattern matching tasks instead of cognitive tasks in order to blind users to their treatment assignment. Similar to the active arm, sham COT will be used daily for 45 minutes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 - 80 years, inclusive at enrollment.
- Diagnosis of current moderate or severe substance use disorders, opioid use disorders, stimulant (cocaine and methamphetamine) use, and alcohol use disorders in the past three months, including the past month.
- Does not meet criteria for other current SUDs outside of the 3 above, except for mild or moderate use of cannabis
- Willing to receive study interventions and buprenorphine (for OUD group) and naltrexone (for AUD group) during the study
- Females must not be pregnant at enrollment and agree not to become pregnant during the trial, through scientifically valid ways of contraception
Key exclusion criteria (9 listed)
- Any significant neurological disease such as stroke, dementia, meningitis, neurosyphilis, cerebral palsy, encephalitis, epilepsy, or seizures.
- Mental retardation.
- Presence of serious mental illness, such as schizophrenia, bipolar disorders, and suicidal risk. Diagnosis of major depressive disorders, anxiety disorders, and post-traumatic stress disorders (PTSD), will be included if symptoms are stable, with no suicidal ideas or plans, and there are no recent changes in treatment of these conditions in the 6 weeks prior to enrollment.
- Experiencing current suicide ideas or plans.
- Any unstable medical condition such as uncontrolled hypertension, uncontrolled diabetes, or liver cirrhosis as determined by the site PI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance)Also: EDITOR plus Treatment-As-Usual (TAU)EDITOR includes a user-friendly cloud portal synced with the main device, providing a comprehensive training program for the orbitofrontal cortex (OFC). The main device stimulates the orbitofrontal cortex intensely, preventing habituation to smells and improving adaptability. This enhances neurobehavioral plasticity, benefiting Substance Use Disorder (SUD) outcomes. The device also features a 60% beta-caryophyllene scent for addressing issues like Alcohol Use Disorder and stimulant use disorders. With ten digital enhancements, it enables remote treatment and data collection, seamlessly transmitting information to healthcare providers through a secure, HIPAA-compliant portal. | Combination product | Enhanced Digital-Chemosensory-Based Olfactory Training (EDITOR) |
| CBOT with olfactory stimulants & OFC tasksAlso: CBOT active plus TAUThe CBOT with proprietary odorant molecules is designed to stimulate olfactory neural activity over long periods of time combined with orbitofrontal cortex (OFC) dependent olfactory tasks. | Combination product | Chemosensory-Based Olfactory Training (CBOT) |
| CBOT ShamAlso: CBOT passive plus TAUCBOT Sham uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive olfactory tasks | Combination product | Chemosensory-Based Olfactory Training (CBOT) Sham |
Primary outcome
Retention in SUD treatment
Time frame: Baseline to day 14
3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
Retention in SUD treatment
Time frame: Baseline to day 28
3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
Retention in SUD treatment
Time frame: Baseline to 8 weeks
3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
Retention in SUD treatment
Time frame: Baseline to three months
3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.
SUD Relapse Rate
Time frame: Baseline to day 7
Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates. Ascertainment of relapse is through: 1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and 2. biochemical verification of drug use from urine samples collected and tested every two weeks.
SUD Relapse Rate
Time frame: Baseline to day 14
Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates. Ascertainment of relapse is through: 1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and 2. biochemical verification of drug use from urine samples collected and tested every two weeks.
SUD Relapse Rate
Time frame: Baseline to day 28
Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates. Ascertainment of relapse is through: 1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and 2. biochemical verification of drug use from urine samples collected and tested every two weeks.
SUD Relapse Rate
Time frame: Baseline to 8 weeks
Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates. Ascertainment of relapse is through: 1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and 2. biochemical verification of drug use from urine samples collected and tested every two weeks.
SUD Relapse Rate
Time frame: Baseline to three months
Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates. Ascertainment of relapse is through: 1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and 2. biochemical verification of drug use from urine samples collected and tested every two weeks.
SUD engagement
Time frame: Baseline to day 14
SUD engagement is the proportion of people treated at baseline who complete the first two weeks of treatment.
28 secondary outcomes
Opioid Craving Scale (OCS)
Time frame: Baseline to Day 7
Cocaine Craving Questionnaire-Brief (CCQ-Brief)
Time frame: Baseline to day 7
Self-report instruments for Alcohol Craving
Time frame: Baseline to day 7
Subjective Opioid Withdrawal Scale (SOWS)
Time frame: Baseline to day 7
Positive and Negative Affect Scales (PANAS)
Time frame: Baseline to day 7
Opioid Craving Scale (OCS)
Time frame: Baseline to day 14
Cocaine Craving Questionnaire-Brief (CCQ-Brief)
Time frame: Baseline to day 14
Self-report instruments for Alcohol Craving
Time frame: Baseline to day 14
Subjective Opioid Withdrawal Scale (SOWS)
Time frame: Baseline to day 14
Positive and Negative Affect Scales (PANAS)
Time frame: Baseline to day 14
Opioid Craving Scale (OCS)
Time frame: Baseline to Day 28
Cocaine Craving Questionnaire-Brief (CCQ-Brief)
Time frame: Baseline to day 28
Self-report instruments for Alcohol Craving
Time frame: Baseline to day 28
Subjective Opioid Withdrawal Scale (SOWS)
Time frame: Baseline to day 28
Positive and Negative Affect Scales (PANAS)
Time frame: Baseline to day 28
Addiction Severity Index (ASI)
Time frame: Baseline to day 28
Opioid Craving Scale (OCS)
Time frame: Baseline to 8 weeks
Cocaine Craving Questionnaire-Brief (CCQ-Brief)
Time frame: Baseline to 8 weeks
Self-report instruments for Alcohol Craving
Time frame: Baseline to 8 weeks
Subjective Opioid Withdrawal Scale (SOWS)
Time frame: Baseline to 8 weeks
Positive and Negative Affect Scales (PANAS)
Time frame: Baseline to 8 weeks
Addiction Severity Index (ASI)
Time frame: Baseline to 8 weeks
Opioid Craving Scale (OCS)
Time frame: Baseline to three months
Cocaine Craving Questionnaire-Brief (CCQ-Brief)
Time frame: Baseline to three months
Self-report instruments for Alcohol Craving
Time frame: Baseline to three months
Subjective Opioid Withdrawal Scale (SOWS)
Time frame: Baseline to three months
Positive and Negative Affect Scales (PANAS)
Time frame: Baseline to three months
Addiction Severity Index (ASI)
Time frame: Baseline to three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Nwaokobia principal investigator
Evon Medics LLC
Evaristus Nwulia, MD principal investigator
Evon Medics LLC
Tanya Alim, MD principal investigator
Howard University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance) and CBOT with olfactory stimulants & OFC tasks in people with Substance Use Disorders and Opioid Use Disorder, run by Evon Medics LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evaristus Nwulia, MD (410-227-2005, enwulia@evonmedics.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in SUD treatment (time frame: Baseline to day 14). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.