Status:
COMPLETED
Patient Driven Recovery With Nalmefene and Coaching
Lead Sponsor:
Yale University
Collaborating Sponsors:
First Pavlov State Medical University in St. Petersburg, Russia
Conditions:
Opioid-use Disorder
Harmful; Use, Alcohol
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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, acce...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03279562
Start Date
September 1 2017
End Date
December 30 2019
Last Update
January 22 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University, Department
New Haven, Connecticut, United States, 06519