Cannabis Abuse, Cannabis Dependence
Conditions
Brief summary
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.
Interventions
DRUGTopiramate
Topiramate (200 mg daily)
DRUGPlacebo
Placebo (daily)
Sponsors
National Institute on Drug Abuse (NIDA)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 20 Years
Healthy volunteers
Yes
Inclusion criteria
* 15 to 20 years old (inclusive) * Non-treatment seeking for cannabis abuse or dependence * Able to read English, understand their rights as provided by the informed consent process, and be willing to sign an informed consent form to participant in the study * If younger than 18 years old, informed consent from a parent or legal guardian is required * Used cannabis at least 2 days per week during the past 30 days
Exclusion criteria
* Treatment seeking or a recent history of treatment for cannabis abuse or dependence * Endorses a current commitment to stop using cannabis * Clinically significant physical abnormalities as indicated by physical exam, hematological assessment, bilirubin concentration or urinalysis * History of renal impairment, renal stones, seizures, or unstable hypertension * Underweight (i.e., less than the 5th percentile) or overweight (equal to or greater than the 95th percentile), as determined by the Body Mass Index * Positive urine toxicology screen for narcotics, amphetamines, or sedative hypnotics or self-reported drug use, other than cannabis, alcohol or nicotine, in the past 30 days * Pregnant, nursing, or refusal to use reliable barrier method of birth control (e.g., condom), if female * Took a psychotropic medication in the past 30 days * Taking medications with a potential effect on cannabis use or a carbonic anhydrase inhibitor * Suicidal * A current DSM-IV-TR Axis I diagnosis other than attention- deficit/hyperactivity disorder or a disruptive behavior disorder * A current substance use disorder other than a cannabis, alcohol, and nicotine use disorders * Significant alcohol withdrawal symptoms * Known sensitivity to topiramate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cannabis Use | Weeks 1-6 | Frequency of Cannabis Use (Percent Use Days Per Week) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of Cannabis Use | Weeks 1-6 | Total Grams of Cannabis Use Per week |
| Amount of Cannabis Use Per Use Day | Weeks 1-6 | Average Grams of Cannabis Used Per Use Day |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Topiramate Topiramate (200 mg daily)
Topiramate: Topiramate (200 mg daily) | 40 |
| Sugar Pill Placebo: Placebo (daily) | 26 |
| Total | 66 |
Baseline characteristics
| Characteristic | Topiramate | Sugar Pill | Total |
|---|---|---|---|
| Age, Continuous | 20.30 years STANDARD_DEVIATION 2.03 | 18.81 years STANDARD_DEVIATION 2.08 | 19.71 years STANDARD_DEVIATION 2.16 |
| Sex: Female, Male Female | 20 Participants | 12 Participants | 32 Participants |
| Sex: Female, Male Male | 20 Participants | 14 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 26 |
| other Total, other adverse events | 35 / 40 | 24 / 26 |
| serious Total, serious adverse events | 0 / 40 | 0 / 26 |
Outcome results
Primary
Cannabis Use
Frequency of Cannabis Use (Percent Use Days Per Week)
Time frame: Weeks 1-6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topiramate | Cannabis Use | 55.89 Percentage of use days | Standard Deviation 32.35 |
| Sugar Pill | Cannabis Use | 63.10 Percentage of use days | Standard Deviation 34.91 |
Secondary
Amount of Cannabis Use Per Use Day
Average Grams of Cannabis Used Per Use Day
Time frame: Weeks 1-6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topiramate | Amount of Cannabis Use Per Use Day | 0.46 Average Grams Per Use Day | Standard Deviation 0.32 |
| Sugar Pill | Amount of Cannabis Use Per Use Day | 0.60 Average Grams Per Use Day | Standard Deviation 0.48 |
Secondary
Quantity of Cannabis Use
Total Grams of Cannabis Use Per week
Time frame: Weeks 1-6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topiramate | Quantity of Cannabis Use | 1.87 Grams Per Week | Standard Deviation 2.11 |
| Sugar Pill | Quantity of Cannabis Use | 2.85 Grams Per Week | Standard Deviation 3.29 |