Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms

Alcohol Drinking Clinical Trial

— IMPACT  

Official title:

Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01641445
• Other study ID #: R01AA007850-21
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2012
• Est. completion date: April 12, 2017

Study information

• Verified date: September 2020
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 12, 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Underage Drinking

Intervention

Drug:
• Topiramate
Topiramate (200 mg daily)
• Placebo
Matching placebo capusules ("sugar pills"

Locations

Country	Name	City	State
United States	Brown University, Center for Alcohol and Addiction Studies	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol Use	Percent drinking days at the target medication dose	Study Weeks 5-8
Primary	Heavy Drinking Days	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.	Study Weeks 5-8
Secondary	Alcohol Use	Percent drinking days at the 6-month follow-up assessment	6-month follow-up assessment
Secondary	Alcohol Use	Percent drinking days at the 12-month follow-up assessment	12-month follow-up assessment