Study of Long-Acting Injectable Naltrexone to Treat Cannabis Dependence

Completed · Phase 1/Phase 2

Conditions studied: Cannabis Dependence

In brief

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.

Key facts

Study ID

NCT02088177

Run by

New York State Psychiatric Institute

People needed

12

Starts

2014-10-01

Expected to finish

2016-03-01

Last updated by the study team

2019-04-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between the ages of 18 - 60 years
• Meets DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, edition IV-TR) criteria for cannabis dependence
• Seeking treatment for cannabis dependence
• Reports using cannabis an average of 5 days per week over the past 28 days
• Capable of giving informed consent and complying with study procedures

You may not qualify if…

• Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder
• Currently meeting DSM-IV criteria for a psychiatric disorder that, according to the investigator's judgment, may require pharmacological or non-pharmacological intervention during the course of the study
• Receiving opioid analgesic medication
• Known history of allergy, intolerance, or hypersensitivity to naltrexone
• Pregnancy, lactation, or failure to use adequate contraceptive methods in female participants who are actively engaging in sexual activity with men
• Unstable medical conditions, such as poorly controlled hypertension or liver disease, which might make participation hazardous
• Chronic pain conditions
• Liver dysfunction as indicated by elevated liver transaminases greater than 2 times the upper limit of normal
• Current DSM-IV diagnosis of substance dependence other than nicotine or cannabis dependence
• Legally mandated to participate in a substance use disorder treatment program
• Risk for suicide

Where it is running

• STARS Downtown, Columbia-Presbyterian and New York State Psychiatric Institute — New York, New York, United States
• STARS clinic, Columbia-New York Presbyterian and New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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