Phase 2 N=82 Randomized Triple-blind Treatment

Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms

Alcohol Drinking

Bottom Line

View on ClinicalTrials.gov: NCT01641445 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Alcohol Use — 29.59; 27.08 Percent of days

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Topiramate (Drug); Placebo (Drug)
Age: Pediatric, Adult · 14+ yrs
Sex: All
Sponsor: Brown University
Primary completion: May 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Alcohol Use	25.55; 21.93	—
PRIMARY Heavy Drinking Days	9.34; 6.78	—
SECONDARY Alcohol Use	25.55; 21.93	—
SECONDARY Alcohol Use	25.55; 21.93	—

Summary

This study will help to determine whether the medication, topiramate, reduces alcohol use among adolescents with alcohol dependence. It will also help answer the question, "How does topiramate reduce drinking in teenagers?" Understanding how topiramate may reduce drinking in adolescents would allow for a more targeted pharmacotherapeutic approach to treatment and help to identify additional medications that may hold promise for improving treatment outcomes for youth.

Eligibility Criteria

Inclusion Criteria

14-24 years old (inclusive)
Non-treatment seeking for alcohol abuse or dependence
Interest in reducing alcohol use
Self-reported alcohol use at least 2 days/week during prior 28 days
Able to read simple English

Exclusion Criteria

Alcohol or substance abuse treatment in the past 30 days
Clinically significant medical abnormalities
History of renal impairment, renal stones, or unstable hypertension
History of progressive neurodegenerative disorders or clinical significant neurological disorders
Body mass index lower than 18
Pregnant, nursing, or refusal to use reliable birth control, if female
Non-stabilized psychotropic medication and/or taking medication that is contraindicated for use with topiramate
Medications that may effect alcohol use or a carbonic anhydrase inhibitor
Suicidal or psychotic
Current coexisting substance use disorders other than alcohol, caffeine, cannabis, or nicotine use disorders
Clinically significant alcohol withdrawal symptoms
Impaired cognitive functioning
Living with an active study participant
Compelled to treatment by the juvenile justice system

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01641445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.