Patient Driven Recovery With Nalmefene and Coaching

Opioid-use Disorder Clinical Trial

Official title:

Patient Driven Recovery With Nalmefene and Coaching

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279562
• Other study ID #: 1610018492
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Harmful; Use, Alcohol
• Opioid-use Disorder

Intervention

Drug:
• Nalmefene
Educational and behaviorally oriented drug counseling

Locations

Country	Name	City	State
United States	Yale University, Department	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	First Pavlov State Medical University in St. Petersburg, Russia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of abstinence from illicit opioids	Days of abstinence from illicit opioids, based on urine tests and self-report	Past 30 days
Secondary	Treatment retention	Duration of treatment participation, number of days in treatment	6 months