Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 14 - 24 |
| Updated: | 4/21/2016 |
| Start Date: | July 2012 |
| End Date: | August 2016 |
| Contact: | Robert M Jr. |
| Email: | Robert_Miranda_Jr@Brown.EDU |
| Phone: | 4018636658 |
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.
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.
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.
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.
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
We found this trial at
1
site
Providence, Rhode Island 02903
Phone: 401-863-6658
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