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Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms

Information source: Brown University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcohol Drinking

Intervention: Topiramate (Drug); Placebo (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Brown University

Official(s) and/or principal investigator(s):
Robert Miranda, Ph.D., Principal Investigator, Affiliation: Brown University

Overall contact:
Robert M Jr., Phone: 4018636658, Email: Robert_Miranda_Jr@Brown.EDU


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.

Clinical Details

Official title: Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Alcohol use

Secondary outcome:

Alcohol craving

Cognitive functioning

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.


Minimum age: 14 Years. Maximum age: 24 Years. Gender(s): Both.


Inclusion Criteria:

- 14-20 years old (inclusive)

- Non-treatment seeking for alcohol abuse or dependence

- Interest in reducing alcohol use

- 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

- Body mass index lower than 18

- Pregnant, nursing, or refusal to use reliable birth control, if female

- Non-stabilized psychotropic medication

- Medications that may effect alcohol use or a carbonic anhydrase inhibitor

- Suicidal or psychotic

- Clinically significant alcohol withdrawal symptoms

- Impaired cognitive functioning

- Living with an active study participant

Locations and Contacts

Robert M Jr., Phone: 4018636658, Email: Robert_Miranda_Jr@Brown.EDU

Brown University, Center for Alcohol and Addiction Studies, Providence, Rhode Island 02912, United States; Recruiting
Robert Jr., Phone: 401-863-6658, Email: Robert_Miranda_Jr@Brown.EDU
Peter Monti, Phone: 4018636661, Email: Peter_Monti@brown.edu
Peter Monti, Ph.D., Sub-Investigator
Jennifer Tidey, Ph.D., Sub-Investigator
Robert Swift, MD, Ph.D., Sub-Investigator
Damaris Rohsenow, Ph.D., Sub-Investigator
Chad Gwaltney, Ph.D., Sub-Investigator
Alicia Justus, Ph.D., Sub-Investigator
Additional Information

Starting date: July 2012
Last updated: July 15, 2014

Page last updated: August 23, 2015

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