Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University of Virginia
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bankole Johnson, University of Virginia
ClinicalTrials.gov Identifier:
NCT00006205
First received: September 11, 2000
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.


Condition Intervention Phase
Alcoholism
Drug: ondansetron + cognitive behavioral therapy
Drug: topiramate + cognitive behavioral therapy
Drug: Placebo + cognitive behavioral therapy
Drug: ondansetron + topiramate + cognitive behavioral therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combining Medications Treatment for Alcoholism

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
    Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT


Secondary Outcome Measures:
  • Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
    Pill Count, Q-LES-Q, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM


Estimated Enrollment: 320
Study Start Date: March 2005
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ondansetron
Ondansetron + cognitive behavioral therapy
Drug: ondansetron + cognitive behavioral therapy
ondansetron (4 mcg/kg b.i.d)
Other Name: Zofran
Experimental: Topiramate
Topiramate + cognitive behavioral therapy
Drug: topiramate + cognitive behavioral therapy
topiramate (up to 300 mg/day)
Other Name: Topamax
Placebo Comparator: Placebo
Placebo + cognitive behavioral therapy
Drug: Placebo + cognitive behavioral therapy
placebo
Other Name: sugar pill
Experimental: Ondansetron + Topiramate
Ondansetron + Topiramate + cognitive behavioral therapy
Drug: ondansetron + topiramate + cognitive behavioral therapy
ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)
Other Name: zofran, topamax

Detailed Description:

This study is a 13 week clinical trial. During the 13 weeks participants receive placebo, ondansetron and topiramate alone or in combination. During the 13 weeks participants come to an outpatient clinic to receive the study medication, physical checks, and cognitive behavioral therapy. The duration of the weekly visit is 3 hours. There is a 1, 2, and 3 month post-study follow up visit. Screening for this study is initially done over the telephone and takes 15-20 minutes. If there is nothing found to make someone ineligible to participate, they come to the out-patient clinic for a more thorough in-clinic screening.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current diagnosis of alcohol dependence and drinking greater than or equal to 14 alcohol drinks/week for women and greater than or equal to 21 alcohol drinks/week for men in the last 30 days.
  • Provide a written, informed consent.
  • Good physical health and must weigh within at least 40 kg and no more than 140 kg.
  • Literate in English and able to read, understand, follow instructions, and complete questionnaires accurately.
  • Willingness to participate in behavioral treatments for alcoholism.
  • Provide evidence of stable residence in the last month prior to enrollment in the study and have no plans to move during the next three months.

Exclusion Criteria:

Please contact site for additional information

  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: NCT00006205

Contacts
Contact: Mindy Borszich 1-888-882-2345 mcb3x@virginia.edu
Contact: Eva Jenkins-Mendoza (434) 243-0562 emj9c@virginia.edu

Locations
United States, Virginia
University of Virginia Center for Addiction Research and Education Recruiting
Charlottesville, Virginia, United States, 22911
Contact: Mindy Borszich    888-882-2345    mcb3x@virginia.edu   
Contact: Eva Jenkins-Mendoza    (434)243-0562    emj9c@virginia.edu   
Principal Investigator: Bankole Johnson, DSc, MD, PhD         
Sub-Investigator: Nassima Ait-Daoud Tiouririne, MD         
University of Virginia Center for Addiction Research and Education Recruiting
Richmond, Virginia, United States, 23294
Contact: Mindy Borszich    888-882-2345    mcb3x@virginia.edu   
Contact: Eva Jenkins-Mendoza    (434)243-0562    emj9c@virginia.edu   
Principal Investigator: Bankole Johnson, DSc, MD, PhD         
Sub-Investigator: Nassima Ait-Daoud Tiouririne, MD         
Sponsors and Collaborators
Bankole Johnson
Investigators
Principal Investigator: Bankole Johnson, DSc, MD, PhD University of Virginia
  More Information

Additional Information:
Publications:
Responsible Party: Bankole Johnson, Chair of Psychiatry and Neurobehavioral Sciences, University of Virginia
ClinicalTrials.gov Identifier: NCT00006205     History of Changes
Other Study ID Numbers: NIAAAJOH1052207A1, R01AA013964
Study First Received: September 11, 2000
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
alcoholism
alcohol addiction

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Ondansetron
Topiramate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents
Anticonvulsants
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents

ClinicalTrials.gov processed this record on July 22, 2014