NCT03279562

Patient Driven Recovery With Nalmefene and Coaching

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Nalmefene	Educational and behaviorally oriented drug counseling

Timeline

• Start date: 2017-09-01
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2017-09-12
• Last updated: 2021-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study