Patient Driven Recovery With Nalmefene and Coaching

Yale University10 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Opioid-use Disorder Harmful; Use, Alcohol

Interventions

NalmefeneDRUG

Educational and behaviorally oriented drug counseling

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

Yale University, Department

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Duration of abstinence from illicit opioids

Days of abstinence from illicit opioids, based on urine tests and self-report

Time frame: Past 30 days

Secondary Outcomes

Treatment retention

Duration of treatment participation, number of days in treatment

Time frame: 6 months

Data from ClinicalTrials.gov

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