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Study of Long-Acting Injectable Naltrexone to Treat Cannabis Dependence

Primary Purpose

Cannabis Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Long-acting injectable naltrexone
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Dependence focused on measuring Cannabis, Cannabis Dependence, Cannabis Use Disorder, Marijuana, Naltrexone, Long Acting Injectable Naltrexone, Treatment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Long-acting injectable naltrexone

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
February 25, 2014
Last Updated
April 22, 2019
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02088177
Brief Title
Study of Long-Acting Injectable Naltrexone to Treat Cannabis Dependence
Official Title
Open-Label Pilot Study of Long-Acting Injectable Naltrexone Treatment for Cannabis Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence
Keywords
Cannabis, Cannabis Dependence, Cannabis Use Disorder, Marijuana, Naltrexone, Long Acting Injectable Naltrexone, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Long-acting injectable naltrexone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Long-acting injectable naltrexone
Other Intervention Name(s)
Vivitrol
Intervention Description
Vivitrol is a long-acting opioid antagonist which blocks opioid agonists from binding at opioid receptors. It be administered as described above.
Primary Outcome Measure Information:
Title
Change in Marijuana Use
Description
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
Title
Number of Participants Receiving the Second Injection of Study Medication
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel P Notzon, M.D.
Organizational Affiliation
Columbia and NY Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
STARS Downtown, Columbia-Presbyterian and New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
STARS clinic, Columbia-New York Presbyterian and New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16223067
Citation
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.
Results Reference
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Study of Long-Acting Injectable Naltrexone to Treat Cannabis Dependence

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