Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02088177
Study type Interventional
Source New York State Psychiatric Institute
Contact
Status Completed
Phase Phase 1/Phase 2
Start date October 2014
Completion date March 2016

See also
  Status Clinical Trial Phase
Completed NCT01005810 - A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana Phase 2
Completed NCT00114439 - Lithium Cannabis Withdrawal Study Phase 2
Completed NCT00350285 - The Teen Marijuana Check-Up Phase 2
Completed NCT01618656 - Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal Phase 2
Completed NCT01153490 - Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users With Quetiapine Phase 4
Completed NCT02946489 - Facilitating the Behavioral Treatment of Cannabis Use Disorder Phase 1
Not yet recruiting NCT01565174 - The Pharmaco-genetic and Brain Mechanisms Associated With Cannabis- Induced Psychosis N/A
Completed NCT01697709 - Quetiapine Pharmacotherapy for Cannabis Dependence Phase 2
Recruiting NCT04721353 - Reducing Cannabis Overuse With Prazosin Phase 4
Completed NCT01603992 - Quiting Marijuana Use: Self-report Study of Quitting Straegies and Withdrawal Symptoms
Completed NCT00167297 - Atomoxetine for the Treatment of Cannabis Dependence Phase 2
Terminated NCT01598896 - Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia Phase 2/Phase 3
Completed NCT01611948 - Treatment for Cannabis Withdrawal and Dependence Phase 2
Recruiting NCT03221231 - N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms Phase 4
Not yet recruiting NCT03366909 - Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness N/A
Completed NCT01639872 - Clozapine for Cannabis Use in Schizophrenia Phase 4
Not yet recruiting NCT06334016 - Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream Early Phase 1
Completed NCT01793961 - Effects of Chronic Intake of Cannabis on Contrast Sensitivity N/A
Completed NCT01747850 - Sativex and Behavioral-relapse Prevention Strategy in Cannabis Dependence Phase 2
Completed NCT01834794 - Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders N/A