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Patient Driven Recovery With Nalmefene and Coaching

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279562
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
First Pavlov State Medical University in St. Petersburg, Russia
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Harmful; Use, Alcohol Drug: Nalmefene Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot, open label, non-randomized clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Driven Recovery With Nalmefene and Coaching
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nalmefene and recovery coaching
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
Other Name: Recovery coaching




Primary Outcome Measures :
  1. Duration of abstinence from illicit opioids [ Time Frame: Past 30 days ]
    Days of abstinence from illicit opioids, based on urine tests and self-report


Secondary Outcome Measures :
  1. Treatment retention [ Time Frame: 6 months ]
    Duration of treatment participation, number of days in treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279562


Locations
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United States, Connecticut
Yale University, Department Recruiting
New Haven, Connecticut, United States, 06519
Contact: Marek C Chawarski, PhD    203-974-7602    marek.chawarski@yale.edu   
Principal Investigator: Marek C Chawarski, PhD         
Sub-Investigator: Evgeny Krupitsky, MD         
Sponsors and Collaborators
Yale University
First Pavlov State Medical University in St. Petersburg, Russia
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03279562    
Other Study ID Numbers: 1610018492
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Nalmefene
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents