Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms
Overview
- Phase
- Phase 1
- Intervention
- Topiramate
- Conditions
- Alcohol Drinking
- Sponsor
- Brown University
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Alcohol Use
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed Description
Adolescent alcohol use is associated with myriad adverse legal, health, and educational consequences and contributes to the leading causes of mortality among youth. Yet despite the magnitude of this public health problem, treatment initiatives for youth remain inadequate. Given these data, the National Institute on Alcohol Abuse and Alcoholism identified the critical need for medications development research for youth with the goal of identifying promising agents for which large-scale clinical trials are justified. The long-term goal of this research program is to improve pharmacotherapy for alcoholism. The major objective of this project is to address the urgent need for empirical data on medications that may benefit youth. For the past 10 years our research program has successfully paired human laboratory paradigms with ecological momentary assessment (EMA), whereby research participants use handheld electronic diaries to monitor their drinking, craving, and sensitivity to alcohol in real time in their natural environment. Using this approach, we identified mechanisms by which medications act and patient characteristics that moderate these effects. The proposed study will test if and how topiramate (TPM), an anticonvulsant shown to be efficacious for treating adults, reduces drinking in youth. To this end, we will randomize adolescent problem drinkers to TPM or placebo for 8 weeks, in combination with biweekly motivational enhancement therapy sessions, using a two-group, double-blind design. While at the target dose (200 mg/day) youth will complete EMA in their natural environment. In addition, youth will complete alcohol cue reactivity assessments in the laboratory to test the effects of TPM on cue-elicited craving and physiological reactivity in a controlled environment. Youth will complete 6- and 12-month follow-up assessments to determine whether any benefits are sustained. This study will provide much needed data on the tolerability and efficacy of TPM with adolescents, while adding important new information about the biobehavioral mechanisms of TPM action in youth.
Investigators
Robert Miranda
Associate Professor (Research)
Brown University
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
Arms & Interventions
Topiramate
Topiramate (200 mg) taken orally daily
Intervention: Topiramate
Sugar pill
Placebo ("sugar pill") taken orally daily
Intervention: Placebo
Outcomes
Primary Outcomes
Alcohol Use
Time Frame: Study Weeks 5-8
Percent drinking days at the target medication dose
Heavy Drinking Days
Time Frame: Study Weeks 5-8
Percent heavy drinking days at the target medication dose. Heavy drinking is defined as 4 or more standard alcoholic drinks per day for females and 5 or more standard drinks per day for males.
Secondary Outcomes
- Alcohol Use(12-month follow-up assessment)