Patient Driven Recovery With Nalmefene and Coaching

Study Overview
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Brief Summary
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In collaboration with the First Pavlov State Medical University in St. Petersburg, Russia, we are proposing a pilot, open label, non-randomized clinical trial to evaluate the safety, feasibility, acceptability, and preliminary efficacy of treatment for alcohol and opioid use disorders combining Nalmefene and recovery coaching (educational and behaviorally oriented drug counseling). The proposed pilot study will also be used to further develop and refine the recovery coaching/counseling intervention and to train additional cadre of clinicians and researchers in St. Petersburg, Russia.

Detailed Description
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The specific aims and hypotheses of the proposed study are as follows: Specific Aim 1: To evaluate the safety, feasibility, acceptability, and preliminary efficacy of treatment of alcohol and opioid use disorders combining Nalmefene and recovery coaching for rehabilitation of detoxified opioid dependent individuals in Russia. Specific Aim 2: To further develop and refine the recovery coaching/counseling intervention and to train additional cadre of clinicians and researchers in St. Petersburg, Russia.

Official Title
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Patient Driven Recovery With Nalmefene and Coaching

Conditions
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Opioid-use Disorder, Harmful; Use, Alcohol

Intervention / Treatment
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* Drug: Nalmefene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: individuals who meet DSM IV criteria for opioid dependence, who use street methadone (the main, most frequently used street opioid in Saint Petersburg, Russia) by intravenous injections, who have a history of alcohol use disorder or high risk alcohol use, who successfully completed inpatient, medically supervised detoxification, who are seeking a rehabilitation treatment following detoxification, and who pass a naloxone challenge (indicating the current lack of physiological dependence on opioids) Exclusion Criteria: current suicide or homicide risk; current psychotic disorder or major depression; inability to understand the consent form or assessments; pregnancy; acute medical conditions requiring medical treatment, co-occurring dependence/abuse of other drugs including alcohol, benzodiazepines, or amphetamine type stimulants (ATS)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot, open label, non-randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nalmefene and recovery coaching<br>Nalmefene prescribed for daily ingestion during the first 3 months of treatment; patients who maintain a successful recovery during the first 3 months of treatment will be offered an option to take Nalmefene on as needed basis, always before encountering situations or circumstances with heightened risk of alcohol or opioid use | Drug: Nalmefene<br>* Educational and behaviorally oriented drug counseling<br>* Other names: Recovery coaching;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of abstinence from illicit opioids | Days of abstinence from illicit opioids, based on urine tests and self-report | Past 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment retention | Duration of treatment participation, number of days in treatment | 6 months |