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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA026778 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Cannabis use is a significant public health concern that disproportionately affect youth. Although promising psychosocial interventions are being developed, most youth do not benefit from these interventions alone. Given the clinical demand for effective treatments, the National Institute on Drug Abuse (NIDA) identified the critical need for data on the tolerability and potential efficacy of medications in adolescents. The purpose of this two-year study is to test if and how topiramate, a medication under intense study for treating several drugs of abuse, reduces cannabis use among teenagers. To this end, the investigators will randomize 56 nontreatment-seeking regular cannabis users (15 or 20 years old) to receive topiramate or placebo for 6 weeks. Youth will monitor their cannabis use for the 6-week period using handheld electronic diaries and complete assessments of reactivity to cannabis-related cues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topiramate | Experimental | Topiramate (200 mg daily) |
|
| Sugar pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate | Drug | Topiramate (200 mg daily) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Cannabis Use | Frequency of Cannabis Use (Percent Use Days Per Week) | Weeks 1-6 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantity of Cannabis Use | Total Grams of Cannabis Use Per week | Weeks 1-6 |
| Amount of Cannabis Use Per Use Day | Average Grams of Cannabis Used Per Use Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Miranda, Ph.D. | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University, Center for Alcohol and Addiction Studies | Providence | Rhode Island | 02912 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34014688 | Derived | Meisel SN, Carpenter RW, Treloar Padovano H, Miranda R. Day-level shifts in social contexts during youth cannabis use treatment. J Consult Clin Psychol. 2021 Apr;89(4):251-263. doi: 10.1037/ccp0000647. | |
| 29672090 | Derived | Treloar Padovano H, Miranda R. Subjective cannabis effects as part of a developing disorder in adolescents and emerging adults. J Abnorm Psychol. 2018 Apr;127(3):282-293. doi: 10.1037/abn0000342. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topiramate | Topiramate (200 mg daily) Topiramate: Topiramate (200 mg daily) |
| FG001 | Sugar Pill | Placebo: Placebo (daily) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topiramate | Topiramate (200 mg daily) Topiramate: Topiramate (200 mg daily) |
| BG001 | Sugar Pill | Placebo: Placebo (daily) |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Cannabis Use | Frequency of Cannabis Use (Percent Use Days Per Week) | Posted | Mean | Standard Deviation | Percentage of use days | Weeks 1-6 |
|
|
Data were collected during the 6-week medication (or placebo pill) period.
We followed the same definition as clinicaltrials.gov.
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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 | Topiramate | Topiramate (200 mg daily) Topiramate: Topiramate (200 mg daily) | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Miranda | Brown University | 401.863.6658 | Robert_Miranda_Jr@brown.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 |
|---|---|
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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| Placebo | Drug | Placebo (daily) |
|
| Weeks 1-6 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
|
| Secondary | Quantity of Cannabis Use | Total Grams of Cannabis Use Per week | Posted | Mean | Standard Deviation | Grams Per Week | Weeks 1-6 |
|
|
|
| Secondary | Amount of Cannabis Use Per Use Day | Average Grams of Cannabis Used Per Use Day | Posted | Mean | Standard Deviation | Average Grams Per Use Day | Weeks 1-6 |
|
|
|
| 40 |
| 0 |
| 40 |
| 35 |
| 40 |
| EG001 | Sugar Pill | Placebo: Placebo (daily) | 0 | 26 | 0 | 26 | 24 | 26 |
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Cough, Cold Symptoms | General disorders | Systematic Assessment |
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| Injury | General disorders | Systematic Assessment |
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| Parasthesias | General disorders | Systematic Assessment |
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| Sore Throat | General disorders | Systematic Assessment |
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| Runny Nose, Sinus Problems, Sneezing | General disorders | Systematic Assessment |
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| Stomach Pain, Cramps | Gastrointestinal disorders | Systematic Assessment |
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| Changes in Vision | Eye disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Decrease in Appetite | General disorders | Systematic Assessment |
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| Weight Loss | General disorders | Systematic Assessment |
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| Irritability | Psychiatric disorders | Systematic Assessment |
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| Nervousness | Psychiatric disorders | Systematic Assessment |
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| Confusion | Psychiatric disorders | Systematic Assessment |
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| Difficulty with Coordination or Balance | General disorders | Systematic Assessment |
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| Difficulty with Memory | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Difficulty with Concentration or Attention | General disorders | Systematic Assessment |
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| Word Finding Difficulties | General disorders | Systematic Assessment |
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| Slow Thinking or Reactions | General disorders | Systematic Assessment |
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| Drowsiness or Sleepiness | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
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| Carbohydrates |
| D007661 | Ketoses |