CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
Topiramate +1 moredrug
Likely dose
Topiramate 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01110434
NCT01110434Phase 2Completed

Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents

Brown University·interventional·Posted Apr 26, 2010·Updated Sep 16, 2020

In Brief

A Phase 2 clinical trial evaluating Topiramate and Placebo for Cannabis Abuse and Cannabis Dependence. Completed, enrolled 66 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 26, 2010
Enrollment StartDec 1, 2009
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 16.2 years ago

Interventions

Topiramatedrug

Topiramate (200 mg daily)

Placebodrug

Placebo (daily)