Back to resultsDronabinol Naltrexone Treatment for Opioid Dependence (Domino)
Primary Purpose
Opioid Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
injectable naltrexone and dronabinol
Naltrexone and placebo
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Dependence focused on measuring opioid dependence, naltrexone, vivitrol, dronabinol, marinol
Eligibility 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
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Naltrexone and placebo
Naltrexone and dronabinol
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) .
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.
Retention
Of those participants randomized to the naltrexone and dronabinol arm, the number that completed all 8 weeks of treatment.
Secondary Outcome Measures
Full Information
NCT ID
NCT01024335
First Posted
November 30, 2009
Last Updated
May 17, 2018
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01024335
Brief Title
Dronabinol Naltrexone Treatment for Opioid Dependence
Acronym
Domino
Official Title
Dronabinol Naltrexone Treatment for Opioid Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence
Keywords
opioid dependence, naltrexone, vivitrol, dronabinol, marinol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naltrexone and placebo
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Naltrexone and dronabinol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
injectable naltrexone and dronabinol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Naltrexone and placebo
Intervention Description
Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks.
Primary Outcome Measure Information:
Title
Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) .
Description
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.
Time Frame
3x/week during 8 weeks of the trial or study participation
Title
Retention
Description
Of those participants randomized to the naltrexone and dronabinol arm, the number that completed all 8 weeks of treatment.
Time Frame
retention over 8 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Bisaga, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
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Dronabinol Naltrexone Treatment for Opioid Dependence
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