Patient Driven Recovery With Nalmefene and Coaching

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.

Study Overview

• Status: Completed
• Conditions: Opioid-use Disorder; Harmful; Use, Alcohol
• Intervention / Treatment: Drug: Nalmefene

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University, Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nalmefene and recovery coaching; 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; Educational and behaviorally oriented drug counseling; Other Names: Recovery coaching

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: First Pavlov State Medical University in St. Petersburg, Russia

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Nalmefene
• Other Study ID Numbers: 1610018492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No