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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Brown University
Sponsor:
Information provided by (Responsible Party):
Robert Miranda, Brown University
ClinicalTrials.gov Identifier:
NCT01641445
First received: July 11, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Alcohol Drinking
Drug: Topiramate
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Alcohol use [ Time Frame: 9-week medication phase ] [ Designated as safety issue: No ]
    Days of abstinence from drinking and of clinically significant drinking


Secondary Outcome Measures:
  • Alcohol craving [ Time Frame: Weekly for 9 weeks, 6- and 12-month follow-up assessments ] [ Designated as safety issue: No ]
    Probability and intensity of subjective craving

  • Cognitive functioning [ Time Frame: Baseline, week 5, and 6-month follow-up assessment ] [ Designated as safety issue: No ]
    Neuropsychological test battery


Estimated Enrollment: 160
Study Start Date: July 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Topiramate
Topiramate (200 mg) taken orally twice daily
Drug: Topiramate
Topiramate (200 mg daily)
Other Name: Topamax
Placebo Comparator: Sugar pill
Placebo ("sugar pill") taken twice daily
Drug: Placebo
Non-active sugar pill

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

Ages Eligible for Study:   14 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641445

Contacts
Contact: Robert M Jr. 4018636658 Robert_Miranda_Jr@Brown.EDU
Contact: Peter Monti 4018636661 Peter_Monti@brown.edu

Locations
United States, Rhode Island
Brown University, Center for Alcohol and Addiction Studies Recruiting
Providence, Rhode Island, United States, 02912
Contact: Robert Jr.    401-863-6658    Robert_Miranda_Jr@Brown.EDU   
Contact: Peter Monti    4018636661    Peter_Monti@brown.edu   
Sub-Investigator: 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.         
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Robert Miranda, Ph.D. Brown University
  More Information

No publications provided

Responsible Party: Robert Miranda, Associate Professor (Research), Brown University
ClinicalTrials.gov Identifier: NCT01641445     History of Changes
Other Study ID Numbers: R01 AA007850-21
Study First Received: July 11, 2012
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Topiramate
Anti-Obesity Agents
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014