Patient Driven Recovery With Nalmefene and Coaching

NCT03279562 | Completed Phase 1 FDA Drug

• 1 other identifier: 1610018492
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder; Harmful; Use, Alcohol

Outcome Measures

Primary Outcomes (1)

• Duration of abstinence from illicit opioids

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

  Past 30 days

Secondary Outcomes (1)

• Treatment retention

  6 months

Study Arms (1)

Nalmefene and recovery coaching

EXPERIMENTAL

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

Interventions

Nalmefene DRUG

Educational and behaviorally oriented drug counseling

Also known as: Recovery coaching

Nalmefene and recovery coaching

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• First Pavlov State Medical University in St. Petersburg, Russia: collaborator

Study Sites (1)

Yale University, Department

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

nalmefene

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot, open label, non-randomized clinical trial

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 12, 2017
• Study Start: September 1, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)