Patient Driven Recovery With Nalmefene and Coaching

Phase 1

Completed

• Conditions: Harmful; Use, Alcohol; Opioid-use Disorder
• Interventions: Drug: Nalmefene

• Registration Number: NCT03279562
• Lead Sponsor: Yale University

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nalmefene and recovery coaching	Nalmefene	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

Primary Outcome Measures

Name	Time	Method
Duration of abstinence from illicit opioids	Past 30 days	Days of abstinence from illicit opioids, based on urine tests and self-report

Secondary Outcome Measures

Name	Time	Method
Treatment retention	6 months	Duration of treatment participation, number of days in treatment

Trial Locations

Locations (1)

Yale University, Department; 🇺🇸 New Haven, Connecticut, United States