Opioid-use DisorderRESTORENCT05053503
Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
A study testing Sparrow Ascent Therapy System, Lofexidine and Extended-release injectable naltrexone in people with Opioid-use Disorder and Opioid Withdrawal, run by Spark Biomedical, Inc. at 4 sites in United States.
Trial summary
The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-use Disorder, Opioid Withdrawal
- What is being tested?
- Sparrow Ascent Therapy System, Lofexidine and Extended-release injectable naltrexone
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 May 2022to 4 Apr 2025
- 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
- Participant shows signs of current opioid dependence; prescription or non-prescription
- Participant COWS score is ≥ 8 or in the opinion of the investigator the participant is in mild to moderate withdrawal at the baseline assessment
- Participant is between 18 and 65 years of age
- Participant is English proficient
- Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
Who cannot join
- Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
- Participant has a history of epileptic seizures
- Participant has a history of neurological diseases or traumatic brain injury
- Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment
- Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
- Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators
Show all 12Show fewer
- Participant has abnormal ear anatomy or ear infection present
- Participant is unwilling to transition to opioid antagonist medication following acute detox treatment
- Subject has significant current suicidal ideation within 30 days prior to Screening as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening, that, in the opinion of the investigator, warrants exclusion from the trial
- Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
- Females who are pregnant or lactating
- Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hazelden Betty Ford Foundation
Center City, Minnesota, 55012
Gaudenzia, Inc.
Crownsville, Maryland, 21032
Hazelden Betty Ford Foundation
Plymouth, Minnesota, 55441
Hazelden Betty Ford Foundation
Rancho Mirage, California, 92270
About this study
The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II.
Read the detailed description
This is a prospective, randomized, controlled, multi-center, clinical trial in which participants with a history of dependence on prescriptive or non-prescriptive opioids will be randomized 2:1 into one of four treatment groups during Phase I (acute detoxification, 7 days):
- Group 1: Active tAN + placebo
- Group 2: Active tAN + lofexidine
- Group 3: Sham tAN + placebo
- Group 4: Sham tAN + lofexidine
Phase I will occur during the participant's treatment in a residential detox center. Participants will have the option to continue into Phase II of the trial at the conclusion of their stay in the residential detox treatment program. In Phase II, participants will be re-randomized 1:1 into one of two treatment groups and will return weekly for 90 days:
- Group 1: Extended-release injectable naltrexone
- Group 2: Active tAN + extended-release injectable naltrexone
- Conditions
- Opioid-use Disorder, Opioid Withdrawal
- Being tested
- Sparrow Ascent Therapy System, Lofexidine, Extended-release injectable naltrexone
- Keywords
- auricular neurostimulation, vagus nerve stimulation, transcutaneous, withdrawal symptoms, relapse prevention
- Medical subject headings
- Opioid-Related Disorders, Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sparrow Ascent Therapy SystemDevice
Transcutaneous auricular neurostimulation (tAN)
LofexidineDrug
Participants will receive 3 lofexidine 0.18 mg/tablets four times per day (daily dose of 2.16 mg) for 7 days.
Extended-release injectable naltrexoneDrug
Participants will receive extended-release injectable naltrexone based on the clinical site's standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Active tAN + placebo | Placebo comparator | tAN will be delivered at a duty cycle of for 5 minutes ON and 10 seconds OFF for up to 168 hours (7 days) therapy duration. Stimulation intensity will be customized to the participants comfort level and within range of therapeutic effectiveness. Participants will receive 3 placebo pills four times per day for 7 days. The placebo will appear similar to lofexidine in size, shape, color, and smell to lofexidine. Receives: Device: Sparrow Ascent Therapy System |
| Active tAN + lofexidine | Active comparator | tAN will be delivered at a duty cycle of for 5 minutes ON and 10 seconds OFF for up to 168 hours (7 days) therapy duration. Stimulation intensity will be customized to the participants comfort level and within range of therapeutic effectiveness. Participants will receive 3 lofexidine 0.18 mg/tablets four times per day (daily dose of 2.16 mg) for 7 days. Receives: Device: Sparrow Ascent Therapy System; Drug: Lofexidine |
| Sham tAN + placebo | No intervention | Participants will have the earpiece applied and the cable connected to the Patient Controller, but tAN stimulation will not be turned on. Participants will receive 3 placebo pills four times per day for 7 days. The placebo will appear similar to lofexidine in size, shape, color, and smell to lofexidine. |
| Sham tAN + lofexidine | Sham comparator | Participants will have the earpiece applied and the cable connected to the Patient Controller, but tAN stimulation will not be turned on. Participants will receive 3 lofexidine 0.18 mg/tablets four times per day (daily dose of 2.16 mg) for 7 days. Receives: Drug: Lofexidine |
| extended-release injectable naltrexone | Active comparator | Extended-release injectable naltrexone will be administered according to the clinical site's standard of care. Receives: Drug: Extended-release injectable naltrexone |
| Active tAN + extended-release injectable naltrexone | Experimental | Extended-release injectable naltrexone will be administered according to the clinical site's standard of care. Participants will be provided with a Spark Sparrow Ascent Therapy System and instructed to administer therapy according to the specified frequencies:
* Month 1 (Days 1 - 28): a minimum of 2 hours per day at least 5 days a week
* Month 2 (Days 29 - 56): a minimum of 2 hours per day at least 3 days a week
* Month 3 (Days 57 - 90: a minimum of 2 hours per day at least 1 day per week Receives: Device: Sparrow Ascent Therapy System; Drug: Extended-release injectable naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
14-Panel Urine Drug Screen
In Phase II, participants will provide a weekly urine sample to determine if opioids have been used in the past week (in conjunction with a self-report). A urine drug screen cup will be used to detect presence of: Amphetamines, Buprenorphine, Benzodiazepines, Cocaine, Ethyl Glucuronide, Fentanyl, Synthetic Marijuana, Ecstasy, Methamphetamines, Methadone, Opiates / Morphine, Oxycodone, Cannabinoid (Marijuana), and Tramadol. The urine drug screen cup also contains a temperature strip to confirm appropriate temperature of the sample and an adulteration panel for determination of sample tampering.
Measured: Weekly throughout Phase II (13 weeks)
Self-Report of Drug Use
In Phase II, participants will be asked weekly to self-report any use of opioids to determine if opioids have been used in the past week (in conjunction with a UDS sample).
Measured: Weekly throughout Phase II (13 weeks)
Secondary outcomes (9)
Clinical Opiate Withdrawal Scale (COWS)
The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale designed to be administered by a clinician. This tool can be used in both inpatient and outpatient settings to reproducibly rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. Scores range between 0 and 48 where total score is the sum of all the items. A higher score indicates more severe withdrawal symptoms. Scores between 5 and 12 indicate mild withdrawal, scores between 13 and 24 indicate moderate withdrawal, scores between 25 and 36 indicate moderately severe withdrawal and scores greater than 36 indicate severe withdrawal. A COWS score reduction of 15% or greater for a given individual is considered clinically significant.
Measured: 60 minutes after treatment initiation (Day 1, Phase I)
Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)
The SOWS-Gossop is an appropriate, precise, and sensitive measure to evaluate the symptoms of acute opioid withdrawal in research or clinical settings. The scale was derived from the original 32-item Opiate Withdrawal Scale to reduce redundancy while providing an equally sensitive measure of opioid withdrawal symptom severity appropriate for research and clinical practice. The assessment is a self-administered test used for the assessment of opiate withdrawal symptoms. The scale contains ten items: yawning, muscular tension, runny eyes, muscle twitching, pains, and aches, feeling of coldness, stomach cramps, insomnia, heart pounding, and feeling sick, making it easy and rapid to administer. The tool has a 4-point rating scale: 0 for 'none,' 1 for 'mild,' 2 for 'moderate,' and 3 for 'severe', with scores ranging from 0 to 30.
Measured: 60 minutes after treatment initiation (Day 1, Phase I)
Clinical Opiate Withdrawal Scale (COWS)
The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale designed to be administered by a clinician. This tool can be used in both inpatient and outpatient settings to reproducibly rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. Scores range between 0 and 48 where total score is the sum of all the items. A higher score indicates more severe withdrawal symptoms. Scores between 5 and 12 indicate mild withdrawal, scores between 13 and 24 indicate moderate withdrawal, scores between 25 and 36 indicate moderately severe withdrawal and scores greater than 36 indicate severe withdrawal. A COWS score reduction of 15% or greater for a given individual is considered clinically significant.
Measured: 6 hours after treatment initiation (Day 1, Phase I)
Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)
The SOWS-Gossop is an appropriate, precise, and sensitive measure to evaluate the symptoms of acute opioid withdrawal in research or clinical settings. The scale was derived from the original 32-item Opiate Withdrawal Scale to reduce redundancy while providing an equally sensitive measure of opioid withdrawal symptom severity appropriate for research and clinical practice. The assessment is a self-administered test used for the assessment of opiate withdrawal symptoms. The scale contains ten items: yawning, muscular tension, runny eyes, muscle twitching, pains, and aches, feeling of coldness, stomach cramps, insomnia, heart pounding, and feeling sick, making it easy and rapid to administer. The tool has a 4-point rating scale: 0 for 'none,' 1 for 'mild,' 2 for 'moderate,' and 3 for 'severe', with scores ranging from 0 to 30.
Measured: 6 hours after treatment initiation (Day 1, Phase I)
Clinical Opiate Withdrawal Scale (COWS)
The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale designed to be administered by a clinician. This tool can be used in both inpatient and outpatient settings to reproducibly rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. Scores range between 0 and 48 where total score is the sum of all the items. A higher score indicates more severe withdrawal symptoms. Scores between 5 and 12 indicate mild withdrawal, scores between 13 and 24 indicate moderate withdrawal, scores between 25 and 36 indicate moderately severe withdrawal and scores greater than 36 indicate severe withdrawal. A COWS score reduction of 15% or greater for a given individual is considered clinically significant.
Measured: Daily on Days 2-7 of Phase I
Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)
The SOWS-Gossop is an appropriate, precise, and sensitive measure to evaluate the symptoms of acute opioid withdrawal in research or clinical settings. The scale was derived from the original 32-item Opiate Withdrawal Scale to reduce redundancy while providing an equally sensitive measure of opioid withdrawal symptom severity appropriate for research and clinical practice. The assessment is a self-administered test used for the assessment of opiate withdrawal symptoms. The scale contains ten items: yawning, muscular tension, runny eyes, muscle twitching, pains, and aches, feeling of coldness, stomach cramps, insomnia, heart pounding, and feeling sick, making it easy and rapid to administer. The tool has a 4-point rating scale: 0 for 'none,' 1 for 'mild,' 2 for 'moderate,' and 3 for 'severe', with scores ranging from 0 to 30.
Measured: Daily on Days 2-7 of Phase I
Opioid Craving Scale (OCS)
The 3-item Opioid Craving Scale was adapted from the 3-item Cocaine Craving Scale for use with opioids. The original 5-item version was found to be valid and unidimensional among cocaine-dependent individuals. Participants are asked to answer the following three questions with responses ranging from 0-10, where 0 = Not at all and 10 = Extremely. Total possible score ranges from 0 to 30 with greater scores indicating higher opioid craving.
- How much do you currently crave opiates?
- 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?
- 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?
Measured: Weekly throughout Phase II (13 weeks)
Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)
The SOWS-Gossop is an appropriate, precise, and sensitive measure to evaluate the symptoms of acute opioid withdrawal in research or clinical settings. The scale was derived from the original 32-item Opiate Withdrawal Scale to reduce redundancy while providing an equally sensitive measure of opioid withdrawal symptom severity appropriate for research and clinical practice. The assessment is a self-administered test used for the assessment of opiate withdrawal symptoms. The scale contains ten items: yawning, muscular tension, runny eyes, muscle twitching, pains, and aches, feeling of coldness, stomach cramps, insomnia, heart pounding, and feeling sick, making it easy and rapid to administer. The tool has a 4-point rating scale: 0 for 'none,' 1 for 'mild,' 2 for 'moderate,' and 3 for 'severe', with scores ranging from 0 to 30.
Measured: Weekly throughout Phase II (13 weeks)
Proportion of patients who receive and tolerate an XR-NTX injection after acute detox treatment (Phase I)
Measured: One hour after receiving first XR-NTX injection (Phase II Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start27 May 2022
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a prospective, randomized, controlled, multi-center, clinical trial in which participants with a history of dependence on prescriptive or non-prescriptive opioids will be randomized 2:1 into one of four treatment groups during Phase I (acute detoxification). Phase I will occur during the participant's treatment in a residential detox center. Participants will have the option to continue into Phase II of the trial at the conclusion of their stay in the residential detox treatment program. In Phase II, participants will be re-randomized 1:1 into one of two treatment groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spark Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hazelden Betty Ford Foundation, Gaudenzia, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053503
- Sponsor's protocol ID
- SBM-OWP-03
- Acronym
- RESTORE
- Status last verified
- Jul 2025
- First submitted
- 16 Aug 2021
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05053503
- Acronym / sponsor ID
- RESTORE / SBM-OWP-03
- Conditions
- Opioid-use Disorder, Opioid Withdrawal
- Keywords
- auricular neurostimulation, vagus nerve stimulation, transcutaneous, withdrawal symptoms, relapse prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Spark Biomedical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hazelden Betty Ford Foundation, Gaudenzia, Inc.
- Study start
- 27 May 2022 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 22 Sep 2021 (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 primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II.
Detailed description
This is a prospective, randomized, controlled, multi-center, clinical trial in which participants with a history of dependence on prescriptive or non-prescriptive opioids will be randomized 2:1 into one of four treatment groups during Phase I (acute detoxification, 7 days):
- Group 1: Active tAN + placebo
- Group 2: Active tAN + lofexidine
- Group 3: Sham tAN + placebo
- Group 4: Sham tAN + lofexidine
Phase I will occur during the participant's treatment in a residential detox center. Participants will have the option to continue into Phase II of the trial at the conclusion of their stay in the residential detox treatment program. In Phase II, participants will be re-randomized 1:1 into one of two treatment groups and will return weekly for 90 days:
- Group 1: Extended-release injectable naltrexone
- Group 2: Active tAN + extended-release injectable naltrexone
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- This is a prospective, randomized, controlled, multi-center, clinical trial in which participants with a history of dependence on prescriptive or non-prescriptive opioids will be randomized 2:1 into one of four treatment groups during Phase I (acute detoxification). Phase I will occur during the participant's treatment in a residential detox center. Participants will have the option to continue into Phase II of the trial at the conclusion of their stay in the residential detox treatment program. In Phase II, participants will be re-randomized 1:1 into one of two treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Active tAN + placebo | Placebo comparator | Device: Sparrow Ascent Therapy SystemtAN will be delivered at a duty cycle of for 5 minutes ON and 10 seconds OFF for up to 168 hours (7 days) therapy duration. Stimulation intensity will be customized to the participants comfort level and within range of therapeutic effectiveness. Participants will receive 3 placebo pills four times per day for 7 days. The placebo will appear similar to lofexidine in size, shape, color, and smell to lofexidine. |
| Active tAN + lofexidine | Active comparator | Device: Sparrow Ascent Therapy System, Drug: LofexidinetAN will be delivered at a duty cycle of for 5 minutes ON and 10 seconds OFF for up to 168 hours (7 days) therapy duration. Stimulation intensity will be customized to the participants comfort level and within range of therapeutic effectiveness. Participants will receive 3 lofexidine 0.18 mg/tablets four times per day (daily dose of 2.16 mg) for 7 days. |
| Sham tAN + placebo | No intervention | –Participants will have the earpiece applied and the cable connected to the Patient Controller, but tAN stimulation will not be turned on. Participants will receive 3 placebo pills four times per day for 7 days. The placebo will appear similar to lofexidine in size, shape, color, and smell to lofexidine. |
| Sham tAN + lofexidine | Sham comparator | Drug: LofexidineParticipants will have the earpiece applied and the cable connected to the Patient Controller, but tAN stimulation will not be turned on. Participants will receive 3 lofexidine 0.18 mg/tablets four times per day (daily dose of 2.16 mg) for 7 days. |
| extended-release injectable naltrexone | Active comparator | Drug: Extended-release injectable naltrexoneExtended-release injectable naltrexone will be administered according to the clinical site's standard of care. |
| Active tAN + extended-release injectable naltrexone | Experimental | Device: Sparrow Ascent Therapy System, Drug: Extended-release injectable naltrexoneExtended-release injectable naltrexone will be administered according to the clinical site's standard of care. Participants will be provided with a Spark Sparrow Ascent Therapy System and instructed to administer therapy according to the specified frequencies: * Month 1 (Days 1 - 28): a minimum of 2 hours per day at least 5 days a week * Month 2 (Days 29 - 56): a minimum of 2 hours per day at least 3 days a week * Month 3 (Days 57 - 90: a minimum of 2 hours per day at least 1 day per week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant shows signs of current opioid dependence; prescription or non-prescription
- Participant COWS score is ≥ 8 or in the opinion of the investigator the participant is in mild to moderate withdrawal at the baseline assessment
- Participant is between 18 and 65 years of age
- Participant is English proficient
- Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
Key exclusion criteria (12 listed)
- Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
- Participant has a history of epileptic seizures
- Participant has a history of neurological diseases or traumatic brain injury
- Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment
- Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
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 |
|---|---|---|
| Sparrow Ascent Therapy SystemTranscutaneous auricular neurostimulation (tAN) | Device | Active tAN + extended-release injectable naltrexone, Active tAN + lofexidine, Active tAN + placebo |
| LofexidineParticipants will receive 3 lofexidine 0.18 mg/tablets four times per day (daily dose of 2.16 mg) for 7 days. | Drug | Active tAN + lofexidine, Sham tAN + lofexidine |
| Extended-release injectable naltrexoneParticipants will receive extended-release injectable naltrexone based on the clinical site's standard of care. | Drug | Active tAN + extended-release injectable naltrexone, extended-release injectable naltrexone |
Primary outcome
14-Panel Urine Drug Screen
Time frame: Weekly throughout Phase II (13 weeks)
In Phase II, participants will provide a weekly urine sample to determine if opioids have been used in the past week (in conjunction with a self-report). A urine drug screen cup will be used to detect presence of: Amphetamines, Buprenorphine, Benzodiazepines, Cocaine, Ethyl Glucuronide, Fentanyl, Synthetic Marijuana, Ecstasy, Methamphetamines, Methadone, Opiates / Morphine, Oxycodone, Cannabinoid (Marijuana), and Tramadol. The urine drug screen cup also contains a temperature strip to confirm appropriate temperature of the sample and an adulteration panel for determination of sample tampering.
Self-Report of Drug Use
Time frame: Weekly throughout Phase II (13 weeks)
In Phase II, participants will be asked weekly to self-report any use of opioids to determine if opioids have been used in the past week (in conjunction with a UDS sample).
9 secondary outcomes
Clinical Opiate Withdrawal Scale (COWS)
Time frame: 60 minutes after treatment initiation (Day 1, Phase I)
Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)
Time frame: 60 minutes after treatment initiation (Day 1, Phase I)
Clinical Opiate Withdrawal Scale (COWS)
Time frame: 6 hours after treatment initiation (Day 1, Phase I)
Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)
Time frame: 6 hours after treatment initiation (Day 1, Phase I)
Clinical Opiate Withdrawal Scale (COWS)
Time frame: Daily on Days 2-7 of Phase I
Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)
Time frame: Daily on Days 2-7 of Phase I
Opioid Craving Scale (OCS)
Time frame: Weekly throughout Phase II (13 weeks)
Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)
Time frame: Weekly throughout Phase II (13 weeks)
Proportion of patients who receive and tolerate an XR-NTX injection after acute detox treatment (Phase I)
Time frame: One hour after receiving first XR-NTX injection (Phase II Day 1)
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 4 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sparrow Ascent Therapy System, Lofexidine and Extended-release injectable naltrexone in people with Opioid-use Disorder and Opioid Withdrawal, run by Spark Biomedical, Inc. at 4 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 5 inclusion and 12 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 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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?
14-Panel Urine Drug Screen (time frame: Weekly throughout Phase II (13 weeks)). The study lists 2 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 4 Jul 2025.