Study of Long-Acting Injectable Naltrexone to Treat Cannabis Dependence
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Marijuana Use [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
- Number of Participants Receiving the Second Injection of Study Medication [Weeks 1 - 5]
The number of participants who accept the second injection at week 5 will be used as one measure of tolerability.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | STARS Downtown, Columbia-Presbyterian and New York State Psychiatric Institute | New York | New York | United States | 10019 |
| 2 | 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
- Principal Investigator: Daniel P Notzon, M.D., Columbia and NY Psychiatric Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- #6799
- DA009236
Study Results
Participant Flow
| Recruitment Details | This trial was conducted at the Substance Treatment and Research Service (STARS), a research clinic at Columbia University Medical Center and the New York State Psychiatric Institute in New York, NY. Participant recruitment began in October 2014 and concluded in January 2016, with data collection completed in March 2016. |
|---|---|
| Pre-assignment Detail | All participants were assigned to treatment with injectable naltrexone under open-label conditions. The first injection was given on study day 1. |
| Arm/Group Title | Open Label Group |
|---|---|
| Arm/Group Description | open label group receiving injections of long acting naltrexone |
| Period Title: Overall Study | |
| STARTED | 12 |
| COMPLETED | 9 |
| NOT COMPLETED | 3 |
Baseline Characteristics
| Arm/Group Title | Open Label Group |
|---|---|
| Arm/Group Description | open label group receiving injections of long acting naltrexone |
| Overall Participants | 12 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
35.42
(9.73)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
5
41.7%
|
| Male |
7
58.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
1
8.3%
|
| Not Hispanic or Latino |
9
75%
|
| Unknown or Not Reported |
2
16.7%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
7
58.3%
|
| White |
2
16.7%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
3
25%
|
| education level (Count of Participants) | |
| High School |
6
50%
|
| Some College |
1
8.3%
|
| post high school technical training |
1
8.3%
|
| College Graduate |
4
33.3%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Label Group |
|---|---|
| Arm/Group Description | open label group receiving injections of long acting naltrexone |
| Measure Participants | 12 |
| Mean (Standard Deviation) [days] |
-1.7
(.51)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Label Group |
|---|---|
| Arm/Group Description | open label group receiving injections of long acting naltrexone |
| Measure Participants | 12 |
| Count of Participants [Participants] |
6
50%
|
Adverse Events
| Time Frame | 8 weeks | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Open Label Group | |
| Arm/Group Description | open label group receiving injections of long acting naltrexone | |
All Cause Mortality |
||
| Open Label Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | |
Serious Adverse Events |
||
| Open Label Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Open Label Group | ||
| Affected / at Risk (%) | # Events | |
| Total | 12/12 (100%) | |
| Gastrointestinal disorders | ||
| nausea | 6/12 (50%) | 6 |
| appetite change | 4/12 (33.3%) | 4 |
| vomitting | 2/12 (16.7%) | 2 |
| dry heaves | 1/12 (8.3%) | 1 |
| General disorders | ||
| insomnia | 6/12 (50%) | 6 |
| irritability | 2/12 (16.7%) | 2 |
| fatigue | 1/12 (8.3%) | 1 |
| headache | 1/12 (8.3%) | 1 |
| vivid dreams | 1/12 (8.3%) | 1 |
| lightheadedness | 1/12 (8.3%) | 1 |
| chills | 1/12 (8.3%) | 1 |
| Injury, poisoning and procedural complications | ||
| induration | 4/12 (33.3%) | 4 |
| Musculoskeletal and connective tissue disorders | ||
| muscle pain | 1/12 (8.3%) | 1 |
| Psychiatric disorders | ||
| anxiety | 3/12 (25%) | 3 |
| Skin and subcutaneous tissue disorders | ||
| diaphoresis | 1/12 (8.3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Frances R. Levin |
|---|---|
| Organization | NYSPI |
| Phone | |
| frl2@cumc.columbia.edu |
- #6799
- DA009236