Dronabinol Naltrexone Treatment for Opioid Dependence (Domino)

May 17, 2018 updated by: Adam Bisaga, New York State Psychiatric Institute
The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We hypothesize that administering dronabinol during detoxification and during the first few weeks of naltrexone treatment will lead to improved naltrexone tolerability, resulting in better naltrexone compliance and treatment retention, and ultimately a reduction in opioid use and relapse rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We are proposing a randomized, double-blind, placebo controlled, parallel-groups, 8 week study of relapse prevention in opioid-dependent individuals. Participants will be randomized into one of two conditions (1) Naltrexone and Placebo (N=20) and (2) Naltrexone and dronabinol 15 mg bid (N=40). Treatment will be delivered in an outpatient setting except for the initial phase of inpatient detoxification, lasting 8 days. A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections), while dronabinol or placebo will be taken daily. In addition, patients will receive a psychosocial intervention that will include elements of motivational interviewing and cognitive-behavioral relapse prevention therapy. The primary aim is to test the efficacy of dronabinol in improving tolerability of naltrexone induction and reducing attrition during detoxification and the first two months of naltrexone treatment. The primary outcome will be the severity of opiate withdrawal and craving. The secondary outcome will be will be retention in treatment at study's end.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Adult, aged 18-60.
  • 2. Meets Diagnostic and Statistical Manual -IV criteria for current opiate dependence disorder of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear.
  • 3. Have a history of marijuana use (more than 30 occasions lifetime)
  • 4. Voluntarily seeking treatment for opioid dependence
  • 5. In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges.
  • 6. Able to give informed consent.

Exclusion Criteria:

  • 1. Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal.
  • 2. Patients meeting current criteria for cannabis abuse or dependence, and those who used cannabis in the week prior to study entry as documented by the positive toxicology
  • 3. Current Diagnostic and Statistical Manual -IV criteria of other substance use disorders. Exceptions include cannabis abuse or dependence, nicotine dependence, cocaine abuse or dependence, alcohol abuse or alcohol dependence without physiological dependence as long as opioid dependence is a primary disorder. Alcohol dependence with physiological dependence is exclusionary.
  • 4. Significant current suicidal risk or 1 or more suicide attempts within the past year
  • 5. History of accidental drug overdose in the last three years defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
  • 6. Positive serum pregnancy test, lactation, or unwillingness to use a satisfactory method of birth control
  • 7. Active psychiatric disorder which might interfere with participation or make participation hazardous, including Diagnostic and Statistical Manual -IV organic mental disorder, psychotic disorder, or bipolar disorder with mania
  • 8. History of allergic reaction, adverse reaction, or sensitivity to any study medication.
  • 9. Acute hepatitis with serum glutamic-oxaloacetic transaminase or serum glutamic-pyruvic transaminase > 3 times the upper end of the laboratory normal range (chronic hepatitis is acceptable as we have found naltrexone treatment well tolerate and safe among patients with chronic hepatitis)
  • 10. Currently prescribed or regularly taking opiates for chronic pain or medical illness.
  • 11. Current participation in a methadone maintenance treatment program and/or regular use of illicit methadone (>30 mg per week).
  • 12. Current participation in another intensive psychotherapy or substance abuse treatment program or participation in another treatment study.
  • 13. Concurrent treatment with psychotropic medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Naltrexone and placebo
A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.
Drug: Naltrexone and placebo
Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks.
Experimental: Naltrexone and dronabinol
A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.
Drug: injectable naltrexone and dronabinol
Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) .
Time Frame: 3x/week during 8 weeks of the trial or study participation
The Subjective Opiate Withdrawal Scale is a self-administered 16 scale containing 16 symptoms ranging in severity from 0 (not at all) to 4 (extremely). The SOWS total score is the sum of 16 items, ranging from 0 (no opiate withdrawal ) to 64 ( severe opiate withdrawal). Values from multiple assessments during the 8-week outpatient phase were averaged.
3x/week during 8 weeks of the trial or study participation
Retention
Time Frame: retention over 8 weeks.
Of those participants randomized to the naltrexone and dronabinol arm, the number that completed all 8 weeks of treatment.
retention over 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Adam Bisaga, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

November 30, 2009

First Posted (Estimate)

December 2, 2009

Study Record Updates

Last Update Posted (Actual)

June 18, 2018

Last Update Submitted That Met QC Criteria

May 17, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #5962 DA027124
  • DPMC (Other Identifier: NIDA)
  • R01DA027124 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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