Clinical trial NCT01641445: Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms
Official title: Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alcohol Drinking
Lead sponsor: Brown University
Sponsor class: OTHER
First posted: 2012-07-16
Enrollment: 82
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Alcohol Use
timeFrame: Study Weeks 5-8
measure: Heavy Drinking Days
timeFrame: Study Weeks 5-8
Secondary outcomes:
measure: Alcohol Use
timeFrame: 6-month follow-up assessment
measure: Alcohol Use
timeFrame: 12-month follow-up assessment
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University, Center for Alcohol and Addiction Studies
state: Rhode Island
Study officials:
affiliation: Brown University
name: Robert Miranda, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: