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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03279562
Other study ID # 1610018492
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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