Patient Driven Recovery With Nalmefene and Coaching

NCT ID: NCT03279562

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-12-30

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.

Conditions

Opioid-use Disorder; Harmful; Use, Alcohol

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Nalmefene

Intervention Type: DRUG

Educational and behaviorally oriented drug counseling

Interventions

Nalmefene

Educational and behaviorally oriented drug counseling

Intervention Type: DRUG

Other Intervention Names

Recovery coaching

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Pavlov State Medical University in St. Petersburg, Russia

UNKNOWN

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yale University, Department

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1610018492

Identifier Type: -

Identifier Source: org_study_id