Overview

Patient Driven Recovery With Nalmefene and Coaching

Status:
Completed

Trial end date:
2019-12-30

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Yale University

Collaborator:

First Pavlov State Medical University in St. Petersburg, Russia

Treatments:

Nalmefene
Naltrexone

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)