Study of Long-Acting Injectable Naltrexone to Treat Cannabis Dependence
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|ClinicalTrials.gov Identifier: NCT02088177|
Recruitment Status : Completed
First Posted : March 14, 2014
Results First Posted : August 18, 2017
Last Update Posted : April 24, 2019
This is an 8 week, outpatient research study testing the use of long-acting naltrexone (Vivitrol) as a treatment for marijuana dependence. Vivitrol is a medication that is effective in treating dependence on opiates and opioids, and in treating dependence on alcohol. It is FDA approved for these disorders. It is a long-acting medication that contains enough medicine in each injection to last for one month. One way it works is by blocking the effects of opiates, including opiates released by the body in response to drugs and alcohol. In this study, we are interested in testing the effects of Vivitrol in people with marijuana dependence.
Individuals participating in this study will receive two Vivitrol injections, each given four weeks apart, (week 1 and week 5). The injection is given in the muscle of the buttock on one side. Participants will attend clinic visits two times a week during this 8-week study for medical management for drug use and for monitoring of physical and psychological health.
|Condition or disease||Intervention/treatment||Phase|
|Cannabis Dependence||Drug: Long-acting injectable naltrexone||Phase 1 Phase 2|
This is an 8 week, outpatient, open-label clinical trial of long-acting injectable naltrexone as a treatment for cannabis dependence.
The purpose of the study will be to evaluate marijuana use patterns and tolerability of long-acting naltrexone in 7 treatment-seeking, cannabis-dependent outpatients; also to assess feasibility of conducting a larger trial with this medication. Cannabis dependent patients will have twice weekly clinic visits where they will receive injections of Vivitrol four weeks apart, in Week 1 and in Week 5. The psychosocial intervention for this study will be Medical Management, designed to facilitate adherence to the study medication and monitoring procedures, as well as to support the participant in achieving his or her marijuana use goals.
Participants will self-report cannabis use, will provide urine toxicology for quantitative assessment of THC (Tetrahydrocannabinol, the active ingredient in marijuana), and will provide serum samples for safety monitoring, and will answer questionnaires and will report on their physical and psychological health weekly.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Pilot Study of Long-Acting Injectable Naltrexone Treatment for Cannabis Dependence|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Experimental: Long-acting injectable naltrexone
Two doses of long-acting injectable naltrexone, 380 mg by intramuscular injection in the gluteal muscle at study day 1 and again between study days 28-30.
Drug: Long-acting injectable naltrexone
Vivitrol is a long-acting opioid antagonist which blocks opioid agonists from binding at opioid receptors. It be administered as described above.
Other Name: Vivitrol
- Change in Marijuana Use [ Time Frame: Weeks 1 - 8 ]Change in marijuana use, as measured by comparing the mean number of self reported days of marijuana use per week in the final study week, which will be week 8 or earlier if the participant discontinues as compared to the mean number of self reported days of marijuana use in week 1
- Number of Participants Receiving the Second Injection of Study Medication [ Time Frame: Weeks 1 - 5 ]The number of participants who accept the second injection at week 5 will be used as one measure of tolerability.
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): NCT02088177
|United States, New York|
|STARS Downtown, Columbia-Presbyterian and New York State Psychiatric Institute|
|New York, New York, United States, 10019|
|STARS clinic, Columbia-New York Presbyterian and New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Daniel P Notzon, M.D.||Columbia and NY Psychiatric Institute|