Dronabinol Naltrexone Treatment for Opioid Dependence (Domino)
|ClinicalTrials.gov Identifier: NCT01024335|
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : September 5, 2014
Last Update Posted : September 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Opioid Dependence||Drug: injectable naltrexone and dronabinol Drug: Naltrexone and placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Dronabinol Naltrexone Treatment for Opioid Dependence|
|Study Start Date :||January 2010|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024335
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Adam Bisaga, MD||Columbia University|