- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05053503
Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder (RESTORE)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Caroline Benner
- Email: caroline.benner@sparkbiomedical.com
Study Contact Backup
- Name: Puja Patel
- Phone Number: 919-986-1619
- Email: ppatel@mcra.com
Study Locations
-
-
California
-
Rancho Mirage, California, United States, 92270
- Recruiting
- Hazelden Betty Ford Foundation
-
Principal Investigator:
- Alta DeRoo, MD
-
Sub-Investigator:
- Jacqueline Braughton, PhD
-
Sub-Investigator:
- Olatunde Bosu, MD
-
Contact:
- Susan Serice, MA
- Email: sserice@hazeldenbettyford.org
-
Sub-Investigator:
- Quyen Ngo, PhD
-
-
Maryland
-
Crownsville, Maryland, United States, 21032
- Recruiting
- Gaudenzia, Inc.
-
Contact:
- Eshawn Bell, LPN
- Email: ebell@gaudenzia.org
-
Contact:
- Michelle Sobek, LPN
- Email: msobek@gaudenzia.org
-
Principal Investigator:
- Philip Moore, DO
-
Sub-Investigator:
- Mary Lilly, RN
-
-
Minnesota
-
Center City, Minnesota, United States, 55012
- Recruiting
- Hazelden Betty Ford Foundation
-
Principal Investigator:
- Alta DeRoo, MD
-
Sub-Investigator:
- Jacqueline Braughton, PhD
-
Sub-Investigator:
- Quyen Ngo, PhD
-
Contact:
- Tara Cantwell, MPH
- Email: tcantwell@hazeldenbettyford.org
-
Contact:
- Mariam Lekuti
- Email: mlekuti@hazeldenbettyford.org
-
Plymouth, Minnesota, United States, 55441
- Recruiting
- Hazelden Betty Ford Foundation
-
Principal Investigator:
- Alta DeRoo, MD
-
Sub-Investigator:
- Jacqueline Braughton, PhD
-
Sub-Investigator:
- Quyen Ngo, PhD
-
Contact:
- Tara Cantwell, MPH
- Email: tcantwell@hazeldenbettyford.org
-
Contact:
- Mariam Lekuti
- Email: mlekuti@hazeldenbettyford.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Active tAN + placebo
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.
|
Transcutaneous auricular neurostimulation (tAN)
|
Active Comparator: Active tAN + lofexidine
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.
|
Transcutaneous auricular neurostimulation (tAN)
Participants will receive 3 lofexidine 0.18 mg/tablets four times per day (daily dose of 2.16 mg) for 7 days.
|
No Intervention: Sham tAN + placebo
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 Comparator: Sham tAN + lofexidine
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.
|
Participants will receive 3 lofexidine 0.18 mg/tablets four times per day (daily dose of 2.16 mg) for 7 days.
|
Active Comparator: extended-release injectable naltrexone
Extended-release injectable naltrexone will be administered according to the clinical site's standard of care.
|
Participants will receive extended-release injectable naltrexone based on the clinical site's standard of care.
|
Experimental: Active tAN + extended-release injectable naltrexone
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:
|
Transcutaneous auricular neurostimulation (tAN)
Participants will receive extended-release injectable naltrexone based on the clinical site's standard of care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Weekly throughout Phase II (13 weeks)
|
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).
|
Weekly throughout Phase II (13 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Opiate Withdrawal Scale (COWS)
Time Frame: 60 minutes after treatment initiation (Day 1, Phase I)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
6 hours after treatment initiation (Day 1, Phase I)
|
Clinical Opiate Withdrawal Scale (COWS)
Time Frame: Daily on Days 2-7 of Phase I
|
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.
|
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
|
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.
|
Daily on Days 2-7 of Phase I
|
Opioid Craving Scale (OCS)
Time Frame: Weekly throughout Phase II (13 weeks)
|
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.
|
Weekly throughout Phase II (13 weeks)
|
Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)
Time Frame: Weekly throughout Phase II (13 weeks)
|
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.
|
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)
|
One hour after receiving first XR-NTX injection (Phase II Day 1)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire (PHQ-9) in Phase I
Time Frame: Baseline and Day 7
|
The PHQ-9 is a validated tool in mental health and considered a powerful tool to assist clinicians with diagnosing depression and monitoring treatment response.
The relationship between opioid use and depression is bidirectional.
The PHQ-9 is a nine-item depression scale and is based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV.
Each of the nine items is rated on a 0 (not at all) to 3 (nearly every day) scale.
A total score is calculated by summing the nine items.
Scores range from 0 to 27 and higher scores indicate a higher degree of depression.
|
Baseline and Day 7
|
Patient Health Questionnaire (PHQ-9) in Phase II
Time Frame: Monthly throughout Phase II (Day 28, 56, and 90)
|
The PHQ-9 is a validated tool in mental health and considered a powerful tool to assist clinicians with diagnosing depression and monitoring treatment response.
The relationship between opioid use and depression is bidirectional.
The PHQ-9 is a nine-item depression scale and is based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV.
Each of the nine items is rated on a 0 (not at all) to 3 (nearly every day) scale.
A total score is calculated by summing the nine items.
Scores range from 0 to 27 and higher scores indicate a higher degree of depression.
|
Monthly throughout Phase II (Day 28, 56, and 90)
|
PTSD Checklist for DSM-5 (PCL-5) in Phase I
Time Frame: Baseline and Day 7
|
Symptoms of post-traumatic stress disorder (PTSD) and opiate dependency may overlap, to which, opioid withdrawal symptoms may emulate PTSD hyperactive startle response.
This is indicative a common physiological mechanism.
The PCL-5 scale is the gold standard in PTSD assessment.
It consisted of a 20-item self-report measurement that is capable of measuring symptom change during and after treatment.
Additionally, the scale can provide a provisional PTSD diagnosis.
Each of the 20 items is rated on a 0 (not at all) to 4 (extremely) scale.
A total symptom severity score is calculated by summing the 20 items.
Scores range from 0 and 80 and higher scores indicating a higher degree of PTSD symptomology.
Evidence suggests that a10 to 20-point reduction in score represents a clinically significant change in PTSD symptoms.
|
Baseline and Day 7
|
PTSD Checklist for DSM-5 (PCL-5) in Phase II
Time Frame: Monthly throughout Phase II (Day 28, 56, and 90)
|
Symptoms of post-traumatic stress disorder (PTSD) and opiate dependency may overlap, to which, opioid withdrawal symptoms may emulate PTSD hyperactive startle response.
This is indicative a common physiological mechanism.
The PCL-5 scale is the gold standard in PTSD assessment.
It consisted of a 20-item self-report measurement that is capable of measuring symptom change during and after treatment.
Additionally, the scale can provide a provisional PTSD diagnosis.
Each of the 20 items is rated on a 0 (not at all) to 4 (extremely) scale.
A total symptom severity score is calculated by summing the 20 items.
Scores range from 0 and 80 and higher scores indicating a higher degree of PTSD symptomology.
Evidence suggests that a10 to 20-point reduction in score represents a clinically significant change in PTSD symptoms.
|
Monthly throughout Phase II (Day 28, 56, and 90)
|
Generalized Anxiety Disorder (GAD-7) in Phase I
Time Frame: Baseline and Day 7
|
The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
The questionnaire consists of 7 questions in which participants are asked to rate each item on a 0 (not at all) to 3 (nearly every day).
GAD-7 total score for the seven items ranges from 0 to 21 where 0-4 represents minimal anxiety, 5-9 represents mild anxiety, 10-14 represents moderate anxiety and 15-21 represent severe anxiety.
|
Baseline and Day 7
|
Generalized Anxiety Disorder (GAD-7) in Phase II
Time Frame: Monthly throughout Phase II (Day 28, 56, and 90)
|
The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
The questionnaire consists of 7 questions in which participants are asked to rate each item on a 0 (not at all) to 3 (nearly every day).
GAD-7 total score for the seven items ranges from 0 to 21 where 0-4 represents minimal anxiety, 5-9 represents mild anxiety, 10-14 represents moderate anxiety and 15-21 represent severe anxiety.
|
Monthly throughout Phase II (Day 28, 56, and 90)
|
World Health Organization Quality of Life (WHOQOL-BREF) in Phase I
Time Frame: Baseline and Day 7
|
The WHOQOL-BREF is a shorter version of the original assessment tool and is commonly used in clinical trials with participants undergoing substance use disorder intervention.
The WHOQOL-BREF is comprised of 26-items and assesses the participant's quality of life across specific domains: physical health, psychological health, social relationships, and environment.
In addition, there are 2 items that measure overall quality of life and general health.
Participants rate how much they have experienced each item in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely).
Domain scores are scaled in a positive direction with higher scores denoting higher quality of life.
The mean score of items within each domain is used to calculate the domain score.
Raw domain scores will be converted to a 0 to 100 scale.
|
Baseline and Day 7
|
World Health Organization Quality of Life (WHOQOL-BREF) in Phase II
Time Frame: Monthly throughout Phase II (Day 28, 56, and 90)
|
The WHOQOL-BREF is a shorter version of the original assessment tool and is commonly used in clinical trials with participants undergoing substance use disorder intervention.
The WHOQOL-BREF is comprised of 26-items and assesses the participant's quality of life across specific domains: physical health, psychological health, social relationships, and environment.
In addition, there are 2 items that measure overall quality of life and general health.
Participants rate how much they have experienced each item in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely).
Domain scores are scaled in a positive direction with higher scores denoting higher quality of life.
The mean score of items within each domain is used to calculate the domain score.
Raw domain scores will be converted to a 0 to 100 scale.
|
Monthly throughout Phase II (Day 28, 56, and 90)
|
Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop) in Phase II
Time Frame: Weekly throughout Phase II (13 weeks)
|
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.
|
Weekly throughout Phase II (13 weeks)
|
14-Panel Urine Drug Screen in Phase I
Time Frame: Baseline and Day 7
|
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.
|
Baseline and Day 7
|
Brief Assessment of Recovery Capital (BARC-10) from Phase I to Phase II
Time Frame: Baseline, Day 7, and monthly throughout Phase II (Day 28, 56, and 90)
|
The BARC-10 is a short,10-item measure that examines recovery capital globally.
Items were selected from the ARC for the BARC-10 using item response theory.
The BARC-10 measures a unidimensional (i.e., global) construct of recovery capital across all the original 10 domains of the ARC.
On average, it takes 2-5 minutes to complete.
Scores range from 6-60.
Individuals who have a recovery capital score of 47 or higher are likely to reach or sustain a year or longer of recovery from substance use disorder.
|
Baseline, Day 7, and monthly throughout Phase II (Day 28, 56, and 90)
|
Xylazine Test Strip Screen in Phase I and Phase II
Time Frame: Baseline, Phase I Day 7, and weekly throughout Phase II (13 weeks)
|
In addition to the 14-Panel Urine Drug Screen cup, a xylazine test strip will be used to detect the presence of xylazine in the urine.
|
Baseline, Phase I Day 7, and weekly throughout Phase II (13 weeks)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Disease Attributes
- Narcotic-Related Disorders
- Substance-Related Disorders
- Recurrence
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Narcotic Antagonists
- Alcohol Deterrents
- Naltrexone
- Lofexidine
Other Study ID Numbers
- SBM-OWP-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Opioid-use Disorder
-
Hennepin Healthcare Research InstituteNational Institute on Drug Abuse (NIDA); The Emmes Company, LLCRecruitingSubstance Use Disorder | Opioid Use Disorder, Moderate | Opioid Use Disorder, SevereUnited States
-
Aurora Health CareUniversity of Chicago; University of California, Santa Cruz; Rogers Behavioral...RecruitingSubstance Use | Methamphetamine-dependence | Opioid Use | Opioid-use Disorder | Cocaine Use Disorder | Cocaine Use | Methamphetamine AbuseUnited States
-
Hennepin Healthcare Research InstituteNational Institute on Drug Abuse (NIDA); The Emmes Company, LLCRecruitingSubstance Use Disorders | Opioid Use Disorder, Moderate | Opioid Use Disorder, SevereUnited States
-
Emory UniversityNational Institute on Drug Abuse (NIDA); Georgia Institute of Technology; CUNYCompletedSubstance-Related Disorders | Substance Abuse, Intravenous | Substance Use Disorders | Opioid Use | Substance Abuse | Opioid-use Disorder | Opioid Use Disorder, Severe | Substance WithdrawalUnited States
-
Vanderbilt University Medical CenterCompletedOpioid Use | Opioid-use DisorderUnited States
-
Indiana UniversityCompletedOpioid Use | Opioid-use DisorderUnited States
-
Albert Einstein College of MedicineNational Institute on Drug Abuse (NIDA); Pfizer; National Institutes of Health...Active, not recruitingTobacco Use Disorder | Opioid-use DisorderUnited States
-
University of ZurichCompletedOpioid Use, Unspecified With Other Opioid-induced DisorderSwitzerland
-
Virginia Commonwealth UniversityNational Institute on Drug Abuse (NIDA)CompletedOpioid-use Disorder | Cocaine Use Disorder | Healthy Controls | Marijuana Use DisorderUnited States
-
Brigham and Women's HospitalOhio State UniversityActive, not recruitingOpioid Dependence | Opioid Use | Opioid-use DisorderUnited States
Clinical Trials on Sparrow Ascent Therapy System
-
University of CincinnatiSpark Biomedical, Inc.Not yet recruitingOpioid Use Disorder | Posttraumatic Stress DisorderUnited States
-
University of Texas Southwestern Medical CenterNot yet recruitingPain, Postoperative | Opioid Use | Lumbar Spine InjuryUnited States
-
Spark Biomedical, Inc.Medical University of South Carolina; University of Texas Southwestern Medical...RecruitingNeonatal Abstinence Syndrome | Neonatal Opioid Withdrawal SyndromeUnited States
-
Spark Biomedical, Inc.CompletedNovel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid WithdrawalOpioid-use Disorder | Opioid WithdrawalUnited States
-
University of North Carolina, GreensboroCompleted
-
Regenesis Biomedical, Inc.CompletedDiabetic Neuropathy PeripheralUnited States
-
Regenesis Biomedical, Inc.CompletedDiabetic Peripheral NeuropathyUnited States
-
Cyberonics, Inc.PRA Health SciencesCompletedEpilepsyNorway, Germany, United Kingdom, Belgium, Netherlands
-
Cyberonics, Inc.Completed
-
ReShape LifesciencesCompletedObesityUnited States, Australia