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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA026782 | U.S. NIH Grant/Contract | View source | |
| DPMCDA |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy of buspirone for reducing marijuana use in marijuana-dependent adults. A contingency management (CM) intervention and motivational enhancement therapy (MET) will be incorporated to encourage study engagement and retention. It is hypothesized that buspirone combined with MET and CM will reduce the percent of marijuana-positive urine drug screen results in marijuana-dependent individuals as compared to a placebo treatment combined with MET and CM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buspirone | Experimental | Buspirone |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buspirone | Drug | Flexible dose, up to 60 mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Marijuana-negative Urine Drug Screens (UDS) | Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group. | Participants provided a once-weekly urine sample for twelve weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Retention in the Study | Number of days subjects remained active in the study | participants were followed for twelve weeks |
| Marijuana Craving | The Marijuana Craving Questionnaire (MCQ) is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1 (least craving) - 7 (most craving) with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. It was administered weekly- reported here is the mean composite score across the 8 week treatment course. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aimee McRae-Clark, Pharm.D. | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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Participants recruited between November 2009 and March 2014 primarily through media and internet advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Buspirone | Buspirone: Flexible dose up to 60 mg/day |
| FG001 | Placebo | Placebo: Flexible dose up to 60mg/day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Buspirone | Buspirone: 30 mg capsules twice daily |
| BG001 | Placebo | Placebo: 30 mg capsules twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percent Marijuana-negative Urine Drug Screens (UDS) | Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group. | Posted | Number | percentage of UDS | Participants provided a once-weekly urine sample for twelve weeks | UDS samples | Participants |
|
|
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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 | Buspirone | Buspirone: Flexible dose up to 60 mg/day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety or Depression | Psychiatric disorders | Non-systematic Assessment |
Limitations included significant attrition during the course of the 12-week trial, difficulty with UCT interpretation due to the long excretion half-life of marijuana in urine, and likelihood that the genetic analysis was underpowered.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aimee McRae-Clark | MUSC | 843.792.5216 | mcraeal@musc.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 |
|---|---|
| D002065 | Buspirone |
| ID | Term |
|---|---|
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Flexible dose, up to 60 mg daily |
|
| 8 Weeks |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
| UDS samples |
|
|
| Secondary | Retention in the Study | Number of days subjects remained active in the study | Posted | Median | Inter-Quartile Range | Day | participants were followed for twelve weeks |
|
|
|
| Secondary | Marijuana Craving | The Marijuana Craving Questionnaire (MCQ) is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1 (least craving) - 7 (most craving) with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. It was administered weekly- reported here is the mean composite score across the 8 week treatment course. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 Weeks |
|
|
|
| 0 |
| 88 |
| 73 |
| 88 |
| EG001 | Placebo | Placebo: Flexible dose up to 60mg/day | 0 | 87 | 66 | 87 |
| Dizziness or lightheaded | Nervous system disorders | Non-systematic Assessment |
|
| Drowsiness | Nervous system disorders | Non-systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | Non-systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Sinus/allergies/flu | General disorders | Non-systematic Assessment |
|
| Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment |
|
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| D010879 |
| Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D011083 | Polycyclic Compounds |