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| ID | Type | Description | Link |
|---|---|---|---|
| DA009236 | Other Grant/Funding Number | National Institutes on Drug Abuse |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel P Notzon, M.D. | Columbia and NY Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| STARS Downtown, Columbia-Presbyterian and New York State Psychiatric Institute | New York | New York | 10019 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16223067 | Result | 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. |
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All participants were assigned to treatment with injectable naltrexone under open-label conditions. The first injection was given on study day 1.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Group | open label group receiving injections of long acting naltrexone |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Group | open label group receiving injections of long acting naltrexone |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | days | Weeks 1 - 8 |
|
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label Group | open label group receiving injections of long acting naltrexone |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| insomnia | General disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frances R. Levin | NYSPI | frl2@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000624616 | vivitrol |
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|
| STARS clinic, Columbia-New York Presbyterian and New York State Psychiatric Institute |
| New York |
| New York |
| 10032 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| education level | Count of Participants | Participants |
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| Primary | 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. | Posted | Count of Participants | Participants | Weeks 1 - 5 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 12 |
| 12 |
| nausea | Gastrointestinal disorders | Systematic Assessment |
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| appetite change | Gastrointestinal disorders | Systematic Assessment |
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| induration | Injury, poisoning and procedural complications | Systematic Assessment |
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| anxiety | Psychiatric disorders | Systematic Assessment |
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| vomitting | Gastrointestinal disorders | Systematic Assessment |
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| irritability | General disorders | Systematic Assessment |
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| fatigue | General disorders | Systematic Assessment |
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| headache | General disorders | Systematic Assessment |
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| muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| vivid dreams | General disorders | Systematic Assessment |
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| diaphoresis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| lightheadedness | General disorders | Systematic Assessment |
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| chills | General disorders | Systematic Assessment |
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| dry heaves | Gastrointestinal disorders | Systematic Assessment |
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