Study of Long-Acting Injectable Naltrexone to Treat Cannabis Dependence

NCT02088177 | Completed Phase 1 Results DMC

• 2 other identifiers: #6799DA009236
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Cannabis Dependence

Keywords

Cannabis; Cannabis Dependence; Cannabis Use Disorder; Marijuana; Naltrexone; Long Acting Injectable Naltrexone; Treatment

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Weeks 1 - 5

Study Arms (1)

Long-acting injectable naltrexone

EXPERIMENTAL

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

Interventions

Long-acting injectable naltrexone DRUG

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

Long-acting injectable naltrexone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (2)

STARS Downtown, Columbia-Presbyterian and New York State Psychiatric Institute

New York, New York, 10019, United States

Location

STARS clinic, Columbia-New York Presbyterian and New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• Johnson BA, Ait-Daoud N, Roache JD. The COMBINE SAFTEE: a structured instrument for collecting adverse events adapted for clinical studies in the alcoholism field. J Stud Alcohol Suppl. 2005 Jul;(15):157-67; discussion 140. doi: 10.15288/jsas.2005.s15.157.

  PMID: 16223067 RESULT

MeSH Terms

Conditions

Marijuana Abuse

Interventions

vivitrol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

Our study is open-label, uncontrolled and with a small sample size, and is not designed to test a priori hypotheses as to the safety, efficacy or effectiveness of our treatment intervention beyond its feasibility for further study.

Results Point of Contact

• Title: Dr. Frances R. Levin
• Organization: NYSPI

frl2@cumc.columbia.edu

Study Officials

• Daniel P Notzon, M.D.

  Columbia and NY Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Substance Use Disorder

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: March 14, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 24, 2019
• Results First Posted: August 18, 2017

Record last verified: 2019-04

Locations

US (2)