DepressionNCT07737652
Microcurrent Neurofeedback as an Adjunct to Standard Care for Substance Use Disorders
A study testing Microcurrent Neurofeedback (MCN) in people with Depression and Anxiety, run by University of Alabama, Tuscaloosa at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether adding Microcurrent Neurofeedback (MCN) to standard residential treatment helps adults with substance use disorder more than standard treatment alone. It will also learn whether MCN is feasible to deliver in a residential treatment setting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety, Substance Use Disorder (SUD)
- What is being tested?
- Microcurrent Neurofeedback (MCN)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2025to 30 Jun 2026
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years at enrollment Current substance use disorder (SUD) diagnosis of any substance type Active enrollment in a residential SUD treatment program, with a minimum of 4 weeks of program enrollment completed prior to study enrollment (stabilization period) Medically stable English proficiency Willingness and ability to provide written informed consent
Who cannot join
- Severe cognitive impairment Active psychosis or acute psychiatric instability Neurological disorder likely to interfere with neurofeedback Concurrent enrollment in another interventional study Current receipt of another form of neurofeedback therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Capstone College of Nursing, 650 University Blvd, 35401 Tuscaloosa
Tuscaloosa, Alabama, 35401
About this study
Official title: Microcurrent Neurofeedback as an Adjunct to Standard Care for Substance Use Disorders: A Single-Site Pilot Randomized Controlled Trial
The goal of this clinical trial is to learn whether adding Microcurrent Neurofeedback (MCN) to standard residential treatment helps adults with substance use disorder more than standard treatment alone. It will also learn whether MCN is feasible to deliver in a residential treatment setting. The main questions it aims to answer are:
Does adding MCN to Standard Care reduce substance cravings more than Standard Care alone? Does adding MCN to Standard Care reduce symptoms of depression, anxiety, and PTSD more than Standard Care alone? Is it feasible to deliver MCN sessions and collect study measurements within a residential treatment program?
Read more
Researchers compared Standard Care plus MCN to Standard Care alone to see whether adding MCN improved outcomes beyond standard treatment.
Participants:
Were enrolled in residential substance use treatment for at least 4 weeks before joining the study Were randomly assigned to receive Standard Care plus MCN or Standard Care alone Those receiving MCN attended 12 sessions over 12 weeks, each lasting 30-45 minutes Completed questionnaires about cravings, depression, anxiety, and PTSD symptoms at the start of the study, at 6 weeks, and at 12 weeks
Read the detailed description
Substance use disorder (SUD) affects millions of adults in the United States, and many people who receive treatment continue to struggle with cravings and co-occurring symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD), even in intensive residential treatment programs. Standard residential treatment typically includes medication (when appropriate), individual and group therapy, and peer support, but craving often persists despite these approaches, leaving room to explore additional treatments that might help.
Microcurrent Neurofeedback (MCN) is a non-invasive technology that uses a person's own brainwave activity (EEG) to guide very low-intensity electrical stimulation delivered through sensors placed on the scalp. The goal is to help normalize patterns of brain activity that may be involved in craving and emotional distress. MCN has shown early promise in small studies for depression, anxiety, and PTSD in general (non-substance-use) populations, but before this study, no randomized trial had tested MCN specifically in adults being treated for substance use disorder.
This study was conducted as a pilot and feasibility trial, meaning its main purpose was to generate early evidence and test whether this type of study could be carried out successfully in a residential treatment setting, rather than to provide a definitive answer about how well MCN works. Feasibility outcomes (such as how many people could be enrolled, how many completed the study, and whether the MCN sessions could be delivered as planned) were considered just as important as the clinical outcomes.
Adults enrolled in residential substance use treatment at a partner treatment facility were invited to participate after completing a required 4-week stabilization period in the program. Eligible participants were randomly assigned, similar to a coin flip, to one of two groups: Standard Care plus MCN, or Standard Care alone. Random assignment helps ensure the two groups are similar at the start of the study, so that any differences seen later are more likely due to the treatment itself rather than pre-existing differences between participants.
Participants assigned to receive MCN attended 12 sessions over 12 weeks, each lasting 30 to 45 minutes, delivered by trained staff in a private room at the treatment facility. Because of the nature of the treatment, participants and staff could not be blinded to which group a person was in (this is known as an open-label design). All participants, regardless of group, continued to receive their regular Standard Care throughout the study.
All participants completed questionnaires about substance cravings, depression, anxiety, and PTSD symptoms at three points during the study: at the start (Baseline), at the midpoint (around 6 weeks), and at the end (around 12 weeks). These questionnaires are widely used, validated tools in mental health and addiction research. Because participants were enrolled in a residential treatment program, some left the program before completing the study, which is a known challenge in this type of research; the study's analysis approach was designed to account for this as much as possible.
A subset of participants also had their brain activity recorded using EEG, and a smaller subset underwent MRI brain scans, to explore whether measurable changes in brain activity or structure accompanied any changes in symptoms. These neuroimaging findings are being analyzed and reported separately from the main clinical results.
This study did not directly measure drug or alcohol use, relapse, or abstinence; it focused specifically on craving and psychiatric symptoms. Findings from this pilot study are intended to inform the design of a larger, more definitive future trial.
- Being tested
- Microcurrent Neurofeedback (MCN), Standard Care for Substance Use Disorder
- Keywords
- Microcurrent Neuorfeedback, PTSD, Anxiety, Neurofeedback, IASIS, Craving, Depression, Substance Use Disorder, Addiction Treatment, Residential Treatment, Polysubstance Use, Pilot study, Feasibility, Substance Craving Scale, Opioid Use Disorder
- Medical subject headings
- Depression, Anxiety Disorders, Substance-Related Disorders, Stress Disorders, Post-Traumatic, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcurrent Neurofeedback (MCN)Device
Also called IASIS Microcurrent Neurofeedback (I-MCN), IASIS LIP-tES
A noninvasive neurophysiological intervention using the IASIS device (Synaptic Tech, LLC), an FDA-cleared Class 2 biofeedback device (Product Code: HCC; Regulation 882.5050; K945826). The device delivers sub-sensory-threshold, low-intensity electrical pulses via scalp sensors placed according to a standardized EEG electrode-placement guide. Protocols are individualized to each participant's EEG profile via real-time monitoring, with stimulation targeted at brain regions implicated in craving and emotional dysregulation, including the anterior cingulate cortex and nucleus accumbens. This FDA clearance covers the device category and does not constitute clearance specifically for treating substance use disorder, craving, PTSD, depression, or anxiety; its use for these indications was investigational in this study. Participants in the experimental arm received 12 sessions (30-45 minutes each) over 12 weeks, twice weekly during alternating weeks, in addition to Standard Care.
Standard Care for Substance Use DisorderBehavioural
Also called Treatment as Usual (TAU)
Standardized program of care delivered throughout the 12-week study period per routine clinical practice at the residential treatment facility, including medications for opioid or alcohol use disorder where clinically indicated (MOUD), individual and group cognitive-behavioral therapy (CBT), 12-step facilitation, and psychosocial support services. Program structure was consistent across participants, though utilization of individual components, particularly medication receipt, varied according to clinical need (e.g., presence of an opioid use disorder). All participants, regardless of study arm, received Standard Care throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care + MCN | Experimental | Participants received Standard Care (medications for opioid or alcohol use disorder where indicated, individual/group CBT, 12-step facilitation, and psychosocial support) plus 12 sessions of Microcurrent Neurofeedback (MCN) over 12 weeks, delivered twice weekly during alternating weeks. Sessions lasted 30-45 minutes and were conducted in a private room by trained, certified personnel using the IASIS device (Synaptic Tech, LLC), an FDA-cleared Class 2 biofeedback device. The device delivers sub-sensory-threshold electrical pulses via scalp sensors, with protocols individualized to each participant's EEG profile. Receives: Device: Microcurrent Neurofeedback (MCN); Behavioral: Standard Care for Substance Use Disorder |
| Standard Care Alone | Active comparator | Participants received Standard Care only, consisting of medications for opioid or alcohol use disorder where clinically indicated (MOUD), individual and group cognitive-behavioral therapy (CBT), 12-step facilitation, and psychosocial support services, per routine clinical practice at the residential treatment facility. Program structure was consistent across participants, though utilization of individual components, particularly medication receipt, varied by clinical need. Receives: Behavioral: Standard Care for Substance Use Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Substance Craving Scale (SCS) Score
The Substance Craving Scale (SCS; Somoza et al., 1995) is a three-item self-report instrument assessing the intensity, frequency, and duration of cravings for the participant's primary substance of use. Items are scored on a four-point scale, yielding a total score of 0 to 12, with higher scores indicating greater craving severity.
Measured: Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12)
Secondary outcomes (3)
Change in Patient Health Questionnaire-9 (PHQ-9) Score
he PHQ-9 (Kroenke et al., 2001) is a nine-item measure of depression symptom severity, with total scores ranging from 0 to 27. Higher scores indicate greater depression severity. Severity categories are minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).
Measured: Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12)
Change in Generalized Anxiety Disorder 7-Item Scale (GAD-7) Score
The GAD-7 (Spitzer et al., 2006) is a seven-item measure of anxiety symptom severity, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety severity. Severity categories are minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21).
Measured: Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12)
Change in PTSD Checklist for DSM-5 (PCL-5) Score
The PCL-5 (Weathers et al., 2013) is a 20-item measure corresponding to DSM-5 PTSD diagnostic criteria, with total scores ranging from 0 to 80. Higher scores indicate greater PTSD symptom severity. A provisional PTSD diagnosis is indicated by a score of 33 or above.
Measured: Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start6 Oct 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel arms: Standard Care plus Microcurrent Neurofeedback (MCN), or Standard Care alone. Randomization was stratified by substance use pattern (single-substance vs. polysubstance use). Both arms were followed concurrently over the same 12-week study period, with assessments at Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12). Participants remained in their assigned arm for the duration of the study; there was no crossover between arms.
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evans Kyei, PhD, MS, University of Alabama, Tuscaloosa
- Investigators
- Evans F Kyei, PhD MSN, RN, Principal investigator, The University of AlabamaMercy N Mumba, PhD BSN, Principal investigator, The University of AlabamaSharlene Newman, PhD, Principal investigator, The University of Alabama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737652
- Sponsor's protocol ID
- UAIRB: 25-04-8568
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: A formal data sharing plan has not yet been established. Individual participant data include information governed by 42 CFR Part 2 (federal confidentiality protections for substance use disorder treatment records), which requires specific consent and de-identification procedures before any data sharing can occur. This pilot trial was conducted to generate preliminary data supporting a planned, larger-scale follow-up study; a data sharing plan will be developed in consultation with the study's institutional review board and legal counsel as part of that future trial's design.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcurrent Neurofeedback as an Adjunct to Standard Care for Substance Use Disorders: A Single-Site Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07737652
- Acronym / sponsor ID
- UAIRB: 25-04-8568
- Keywords
- Microcurrent Neuorfeedback, PTSD, Anxiety, Neurofeedback, IASIS, Craving, Depression, Substance Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 30 Jul 2026 (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 goal of this clinical trial is to learn whether adding Microcurrent Neurofeedback (MCN) to standard residential treatment helps adults with substance use disorder more than standard treatment alone. It will also learn whether MCN is feasible to deliver in a residential treatment setting. The main questions it aims to answer are:
Does adding MCN to Standard Care reduce substance cravings more than Standard Care alone? Does adding MCN to Standard Care reduce symptoms of depression, anxiety, and PTSD more than Standard Care alone? Is it feasible to deliver MCN sessions and collect study measurements within a residential treatment program?
Researchers compared Standard Care plus MCN to Standard Care alone to see whether adding MCN improved outcomes beyond standard treatment.
Participants:
Were enrolled in residential substance use treatment for at least 4 weeks before joining the study Were randomly assigned to receive Standard Care plus MCN or Standard Care alone Those receiving MCN attended 12 sessions over 12 weeks, each lasting 30-45 minutes Completed questionnaires about cravings, depression, anxiety, and PTSD symptoms at the start of the study, at 6 weeks, and at 12 weeks
Detailed description
Substance use disorder (SUD) affects millions of adults in the United States, and many people who receive treatment continue to struggle with cravings and co-occurring symptoms of depression, anxiety, and post-traumatic stress disorder (PTSD), even in intensive residential treatment programs. Standard residential treatment typically includes medication (when appropriate), individual and group therapy, and peer support, but craving often persists despite these approaches, leaving room to explore additional treatments that might help.
Microcurrent Neurofeedback (MCN) is a non-invasive technology that uses a person's own brainwave activity (EEG) to guide very low-intensity electrical stimulation delivered through sensors placed on the scalp. The goal is to help normalize patterns of brain activity that may be involved in craving and emotional distress. MCN has shown early promise in small studies for depression, anxiety, and PTSD in general (non-substance-use) populations, but before this study, no randomized trial had tested MCN specifically in adults being treated for substance use disorder.
This study was conducted as a pilot and feasibility trial, meaning its main purpose was to generate early evidence and test whether this type of study could be carried out successfully in a residential treatment setting, rather than to provide a definitive answer about how well MCN works. Feasibility outcomes (such as how many people could be enrolled, how many completed the study, and whether the MCN sessions could be delivered as planned) were considered just as important as the clinical outcomes.
Adults enrolled in residential substance use treatment at a partner treatment facility were invited to participate after completing a required 4-week stabilization period in the program. Eligible participants were randomly assigned, similar to a coin flip, to one of two groups: Standard Care plus MCN, or Standard Care alone. Random assignment helps ensure the two groups are similar at the start of the study, so that any differences seen later are more likely due to the treatment itself rather than pre-existing differences between participants.
Participants assigned to receive MCN attended 12 sessions over 12 weeks, each lasting 30 to 45 minutes, delivered by trained staff in a private room at the treatment facility. Because of the nature of the treatment, participants and staff could not be blinded to which group a person was in (this is known as an open-label design). All participants, regardless of group, continued to receive their regular Standard Care throughout the study.
All participants completed questionnaires about substance cravings, depression, anxiety, and PTSD symptoms at three points during the study: at the start (Baseline), at the midpoint (around 6 weeks), and at the end (around 12 weeks). These questionnaires are widely used, validated tools in mental health and addiction research. Because participants were enrolled in a residential treatment program, some left the program before completing the study, which is a known challenge in this type of research; the study's analysis approach was designed to account for this as much as possible.
A subset of participants also had their brain activity recorded using EEG, and a smaller subset underwent MRI brain scans, to explore whether measurable changes in brain activity or structure accompanied any changes in symptoms. These neuroimaging findings are being analyzed and reported separately from the main clinical results.
This study did not directly measure drug or alcohol use, relapse, or abstinence; it focused specifically on craving and psychiatric symptoms. Findings from this pilot study are intended to inform the design of a larger, more definitive future trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel arms: Standard Care plus Microcurrent Neurofeedback (MCN), or Standard Care alone. Randomization was stratified by substance use pattern (single-substance vs. polysubstance use). Both arms were followed concurrently over the same 12-week study period, with assessments at Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12). Participants remained in their assigned arm for the duration of the study; there was no crossover between arms.
| Arm | Type | Receives |
|---|---|---|
| Standard Care + MCN | Experimental | Device: Microcurrent Neurofeedback (MCN), Behavioral: Standard Care for Substance Use DisorderParticipants received Standard Care (medications for opioid or alcohol use disorder where indicated, individual/group CBT, 12-step facilitation, and psychosocial support) plus 12 sessions of Microcurrent Neurofeedback (MCN) over 12 weeks, delivered twice weekly during alternating weeks. Sessions lasted 30-45 minutes and were conducted in a private room by trained, certified personnel using the IASIS device (Synaptic Tech, LLC), an FDA-cleared Class 2 biofeedback device. The device delivers sub-sensory-threshold electrical pulses via scalp sensors, with protocols individualized to each participant's EEG profile. |
| Standard Care Alone | Active comparator | Behavioral: Standard Care for Substance Use DisorderParticipants received Standard Care only, consisting of medications for opioid or alcohol use disorder where clinically indicated (MOUD), individual and group cognitive-behavioral therapy (CBT), 12-step facilitation, and psychosocial support services, per routine clinical practice at the residential treatment facility. Program structure was consistent across participants, though utilization of individual components, particularly medication receipt, varied by clinical need. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 to 65 years at enrollment Current substance use disorder (SUD) diagnosis of any substance type Active enrollment in a residential SUD treatment program, with a minimum of 4 weeks of program enrollment completed prior to study enrollment (stabilization period) Medically stable English proficiency Willingness and ability to provide written informed consent
Key exclusion criteria (1 listed)
- Severe cognitive impairment Active psychosis or acute psychiatric instability Neurological disorder likely to interfere with neurofeedback Concurrent enrollment in another interventional study Current receipt of another form of neurofeedback therapy
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 |
|---|---|---|
| Microcurrent Neurofeedback (MCN)Also: IASIS Microcurrent Neurofeedback (I-MCN), IASIS LIP-tESA noninvasive neurophysiological intervention using the IASIS device (Synaptic Tech, LLC), an FDA-cleared Class 2 biofeedback device (Product Code: HCC; Regulation 882.5050; K945826). The device delivers sub-sensory-threshold, low-intensity electrical pulses via scalp sensors placed according to a standardized EEG electrode-placement guide. Protocols are individualized to each participant's EEG profile via real-time monitoring, with stimulation targeted at brain regions implicated in craving and emotional dysregulation, including the anterior cingulate cortex and nucleus accumbens. This FDA clearance covers the device category and does not constitute clearance specifically for treating substance use disorder, craving, PTSD, depression, or anxiety; its use for these indications was investigational in this study. Participants in the experimental arm received 12 sessions (30-45 minutes each) over 12 weeks, twice weekly during alternating weeks, in addition to Standard Care. | Device | Standard Care + MCN |
| Standard Care for Substance Use DisorderAlso: Treatment as Usual (TAU)Standardized program of care delivered throughout the 12-week study period per routine clinical practice at the residential treatment facility, including medications for opioid or alcohol use disorder where clinically indicated (MOUD), individual and group cognitive-behavioral therapy (CBT), 12-step facilitation, and psychosocial support services. Program structure was consistent across participants, though utilization of individual components, particularly medication receipt, varied according to clinical need (e.g., presence of an opioid use disorder). All participants, regardless of study arm, received Standard Care throughout the study period. | Behavioural | Standard Care + MCN, Standard Care Alone |
Primary outcome
Change in Substance Craving Scale (SCS) Score
Time frame: Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12)
The Substance Craving Scale (SCS; Somoza et al., 1995) is a three-item self-report instrument assessing the intensity, frequency, and duration of cravings for the participant's primary substance of use. Items are scored on a four-point scale, yielding a total score of 0 to 12, with higher scores indicating greater craving severity.
3 secondary outcomes
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12)
Change in Generalized Anxiety Disorder 7-Item Scale (GAD-7) Score
Time frame: Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12)
Change in PTSD Checklist for DSM-5 (PCL-5) Score
Time frame: Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided. A formal data sharing plan has not yet been established. Individual participant data include information governed by 42 CFR Part 2 (federal confidentiality protections for substance use disorder treatment records), which requires specific consent and de-identification procedures before any data sharing can occur. This pilot trial was conducted to generate preliminary data supporting a planned, larger-scale follow-up study; a data sharing plan will be developed in consultation with the study's institutional review board and legal counsel as part of that future trial's design.
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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.
Evans F Kyei, PhD MSN, RN principal investigator
The University of Alabama
Mercy N Mumba, PhD BSN principal investigator
The University of Alabama
Sharlene Newman, PhD principal investigator
The University of Alabama
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microcurrent Neurofeedback (MCN) in people with Depression and Anxiety, run by University of Alabama, Tuscaloosa at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Substance Craving Scale (SCS) Score (time frame: Baseline, Mid-Point (Week 6), and Post-Intervention (Week 12)). 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 Jul 2026.