Back to resultsPatient Driven Recovery With Nalmefene and Coaching
Primary Purpose
Opioid-use Disorder, Harmful; Use, Alcohol
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nalmefene
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder
Eligibility Criteria
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)
Sites / Locations
- Yale University, Department
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nalmefene and recovery coaching
Arm Description
Nalmefene prescribed for daily ingestion during the first 3 months of treatment; patients who maintain a successful recovery during the first 3 months of treatment will be offered an option to take Nalmefene on as needed basis, always before encountering situations or circumstances with heightened risk of alcohol or opioid use
Outcomes
Primary Outcome Measures
Duration of abstinence from illicit opioids
Days of abstinence from illicit opioids, based on urine tests and self-report
Secondary Outcome Measures
Treatment retention
Duration of treatment participation, number of days in treatment
Full Information
NCT ID
NCT03279562
First Posted
September 6, 2017
Last Updated
January 19, 2021
Sponsor
Yale University
Collaborators
First Pavlov State Medical University in St. Petersburg, Russia
1. Study Identification
Unique Protocol Identification Number
NCT03279562
Brief Title
Patient Driven Recovery With Nalmefene and Coaching
Official Title
Patient Driven Recovery With Nalmefene and Coaching
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
First Pavlov State Medical University in St. Petersburg, Russia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Harmful; Use, Alcohol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Pilot, open label, non-randomized clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nalmefene and recovery coaching
Arm Type
Experimental
Arm Description
Nalmefene prescribed for daily ingestion during the first 3 months of treatment; patients who maintain a successful recovery during the first 3 months of treatment will be offered an option to take Nalmefene on as needed basis, always before encountering situations or circumstances with heightened risk of alcohol or opioid use
Intervention Type
Drug
Intervention Name(s)
Nalmefene
Other Intervention Name(s)
Recovery coaching
Intervention Description
Educational and behaviorally oriented drug counseling
Primary Outcome Measure Information:
Title
Duration of abstinence from illicit opioids
Description
Days of abstinence from illicit opioids, based on urine tests and self-report
Time Frame
Past 30 days
Secondary Outcome Measure Information:
Title
Treatment retention
Description
Duration of treatment participation, number of days in treatment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Yale University, Department
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patient Driven Recovery With Nalmefene and Coaching
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