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Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01641445
Recruitment Status : Completed
First Posted : July 16, 2012
Results First Posted : September 17, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Robert Miranda, Brown University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Drug: Topiramate Drug: Placebo Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms
Study Start Date : July 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : April 12, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Topiramate
Topiramate (200 mg) taken orally daily
 Drug: Topiramate
Topiramate (200 mg daily)
Other Name: Topamax
Placebo Comparator: Sugar pill
Placebo ("sugar pill") taken orally daily
 Drug: Placebo
Matching placebo capusules ("sugar pills"
Other Name: "Sugar Pill"


Outcome Measures
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Primary Outcome Measures :
  1. Alcohol Use [ Time Frame: Study Weeks 5-8 ]
    Percent drinking days at the target medication dose

  2. 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 Outcome Measures :
  1. Alcohol Use [ Time Frame: 6-month follow-up assessment ]
    Percent drinking days at the 6-month follow-up assessment

  2. Alcohol Use [ Time Frame: 12-month follow-up assessment ]
    Percent drinking days at the 12-month follow-up assessment


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641445


Locations
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United States, Rhode Island
Brown University, Center for Alcohol and Addiction Studies
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
Investigators
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Principal Investigator: Robert Miranda, Ph.D. Brown University
  Study Documents (Full-Text)

Documents provided by Robert Miranda, Brown University:
Informed Consent Form  [PDF] January 15, 2016

More Information
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Responsible Party: Robert Miranda, Associate Professor (Research), Brown University
ClinicalTrials.gov Identifier: NCT01641445    
Other Study ID Numbers: R01AA007850-21 ( U.S. NIH Grant/Contract )
First Posted: July 16, 2012    Key Record Dates
Results First Posted: September 17, 2020
Last Update Posted: October 20, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Alcohol Drinking
Underage Drinking
Drinking Behavior
Topiramate
 Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs