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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
Sponsor:
Information provided by (Responsible Party):
Frances R Levin, New York State Psychiatric Institute

Brief 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.


Condition or disease Intervention/treatment Phase
Cannabis Dependence Drug: Long-acting injectable naltrexone Phase 1 Phase 2

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
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Principal Investigator: Daniel P Notzon, M.D. Columbia and NY Psychiatric Institute

Publications of Results:
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Responsible Party: Frances R Levin, Director of Substance Use Disorder, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02088177     History of Changes
Other Study ID Numbers: #6799
DA009236 ( Other Grant/Funding Number: National Institutes on Drug Abuse )
First Posted: March 14, 2014    Key Record Dates
Results First Posted: August 18, 2017
Last Update Posted: April 24, 2019
Last Verified: April 2019
Keywords provided by Frances R Levin, New York State Psychiatric Institute:
Cannabis
Cannabis Dependence
Cannabis Use Disorder
Marijuana
Naltrexone
Long Acting Injectable Naltrexone
Treatment
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents