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Dronabinol Naltrexone Treatment for Opioid Dependence (Domino)

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ClinicalTrials.gov Identifier: NCT01024335
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : September 5, 2014
Last Update Posted : June 18, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Adam Bisaga, National Institute on Drug Abuse (NIDA)

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Opioid Dependence Drug: injectable naltrexone and dronabinol Drug: Naltrexone and placebo Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dronabinol Naltrexone Treatment for Opioid Dependence
Study Start Date : January 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01024335


Locations
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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Adam Bisaga, MD Columbia University
More Information
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Responsible Party: Adam Bisaga, Research Psychiatrist, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT01024335    
Other Study ID Numbers: #5962 DA027124
R01DA027124 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Posted: December 2, 2009    Key Record Dates
Results First Posted: September 5, 2014
Last Update Posted: June 18, 2018
Last Verified: May 2018
Keywords provided by Adam Bisaga, National Institute on Drug Abuse (NIDA):
opioid dependence
naltrexone
vivitrol
dronabinol
marinol
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Dronabinol
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists