A Phase 1/2 interventional study of Long-acting injectable naltrexone in Cannabis Dependence, sponsored by New York State Psychiatric Institute. Completed at 2 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-04-24.
Sponsored by New York State Psychiatric Institute · Phase 1/2, Interventional, and Treatment
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.
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.
530 studies on the registry are indexed under Marijuana Abuse; 114 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 431 interventional studies indexed under Marijuana Abuse.
Browse Marijuana Abuse studies →New York State Psychiatric Institute is the lead sponsor of 433 studies on the registry; 25 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
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Exclusion Criteria:
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.
Also known as: Vivitrol
Change in Marijuana Use
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
Time frame: Weeks 1 - 8
Number of Participants Receiving the Second Injection of Study Medication
The number of participants who accept the second injection at week 5 will be used as one measure of tolerability.
Time frame: Weeks 1 - 5
This trial was conducted at the Substance Treatment and Research Service (STARS), a research clinic at Columbia University Medical Center and the New York State Psychiatric Institute in New York, NY. Participant recruitment began in October 2014 and concluded in January 2016, with data collection completed in March 2016.
| Milestone | Open Label Group |
|---|---|
| Started | 12 |
| Completed | 9 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 3 |
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
| days | Open Label Group |
|---|---|
| Change in Marijuana Use | -1.7 ± .51 |
The number of participants who accept the second injection at week 5 will be used as one measure of tolerability.
| Participants | Open Label Group |
|---|---|
| Number of Participants Receiving the Second Injection of Study Medication | 6 |
Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open Label Group | 0/12 (0%) | 0/12 (0%) | 12/12 (100%) |
| Event | Open Label Group |
|---|---|
| insomniaGeneral disorders | 6/12 |
| nauseaGastrointestinal disorders | 6/12 |
| appetite changeGastrointestinal disorders | 4/12 |
| indurationInjury, poisoning and procedural complications | 4/12 |
| anxietyPsychiatric disorders | 3/12 |
| vomittingGastrointestinal disorders | 2/12 |
| irritabilityGeneral disorders | 2/12 |
| fatigueGeneral disorders | 1/12 |
| headacheGeneral disorders | 1/12 |
| muscle painMusculoskeletal and connective tissue disorders | 1/12 |
| Age, Continuous(years) | Open Label Group |
|---|---|
| Mean | 35.42 ± 9.73 |
| Sex: Female, Male(Participants) | Open Label Group |
|---|---|
| Female | 5 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | Open Label Group |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Open Label Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| education level(Participants) | Open Label Group |
|---|---|
| High School | 6 |
| Some College | 1 |
| post high school technical training | 1 |
| College Graduate | 4 |
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vivitrol
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