A Phase 1 interventional study of Nalmefene in Opioid-use Disorder and Harmful; Use, Alcohol, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by Yale University · Phase 1, Interventional, and Treatment
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.
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.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 10 is below the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
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Exclusion Criteria:
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
Drug: Nalmefene
Educational and behaviorally oriented drug counseling
Also known as: Recovery coaching
Duration of abstinence from illicit opioids
Days of abstinence from illicit opioids, based on urine tests and self-report
Time frame: Past 30 days
Treatment retention
Duration of treatment participation, number of days in treatment
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Dec 2019, 27 months.
Of 53 non-industry phase 1 interventional studies under Opioid-Related Disorders, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 47. This study's 27 months is close to that.
Counting every sponsor, half of 77 studies reached it within 19 months; a quarter within 9 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nalmefene