Opioid-use Disorder Clinical Trial
Official title:
Patient Driven Recovery With Nalmefene and Coaching
Verified date | January 2021 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | Yale University, Department | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | First Pavlov State Medical University in St. Petersburg, Russia |
United States,
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 |
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