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

This study is currently recruiting participants.
Verified July 2012 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 12, 2012
Last verified: July 2012
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Alcohol
Drug Information available for: Topiramate
U.S. FDA Resources

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 Drug: Topiramate
Topiramate (200 mg daily)
Other Name: Topamax
Placebo Comparator: Sugar pill Drug: Placebo
Non-active sugar pill

  Eligibility

Ages Eligible for Study:   14 Years to 20 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
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
  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 12, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013