Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

NCT ID: NCT00006205

Last Updated: 2013-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2013-12-31

Brief Summary

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.

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.

Conditions

Alcoholism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ondansetron

Ondansetron + cognitive behavioral therapy

Group Type: EXPERIMENTAL

ondansetron + cognitive behavioral therapy

Intervention Type: DRUG

ondansetron (4 mcg/kg b.i.d)

Topiramate

Topiramate + cognitive behavioral therapy

Group Type: EXPERIMENTAL

topiramate + cognitive behavioral therapy

Intervention Type: DRUG

topiramate (up to 300 mg/day)

Placebo

Placebo + cognitive behavioral therapy

Group Type: PLACEBO_COMPARATOR

Placebo + cognitive behavioral therapy

Intervention Type: DRUG

placebo

Ondansetron + Topiramate

Ondansetron + Topiramate + cognitive behavioral therapy

Group Type: EXPERIMENTAL

ondansetron + topiramate + cognitive behavioral therapy

Intervention Type: DRUG

ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)

Interventions

ondansetron + cognitive behavioral therapy

ondansetron (4 mcg/kg b.i.d)

Intervention Type: DRUG

topiramate + cognitive behavioral therapy

topiramate (up to 300 mg/day)

Intervention Type: DRUG

Placebo + cognitive behavioral therapy

placebo

Intervention Type: DRUG

ondansetron + topiramate + cognitive behavioral therapy

ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)

Intervention Type: DRUG

Other Intervention Names

Zofran; Topamax; sugar pill; zofran, topamax

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Bankole Johnson

OTHER

Sponsor Role: lead

Responsible Party

Bankole Johnson

Chair of Psychiatry and Neurobehavioral Sciences

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bankole Johnson, DSc, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Center for Addiction Research and Education

Charlottesville, Virginia, United States

Site Status: RECRUITING

University of Virginia Center for Addiction Research and Education

Richmond, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mindy Borszich

Role: CONTACT

mcb3x@virginia.edu

1-888-882-2345

Eva Jenkins-Mendoza

Role: CONTACT

emj9c@virginia.edu

(434) 243-0562

Facility Contacts

Mindy Borszich

Role: primary

mcb3x@virginia.edu

888-882-2345

Eva Jenkins-Mendoza

Role: backup

emj9c@virginia.edu

(434)243-0562

Mindy Borszich

Role: primary

mcb3x@virginia.edu

888-882-2345

Eva Jenkins-Mendoza

Role: backup

emj9c@virginia.edu

(434)243-0562

References

Johnson BA. An overview of the development of medications including novel anticonvulsants for the treatment of alcohol dependence. Expert Opin Pharmacother. 2004 Sep;5(9):1943-55. doi: 10.1517/14656566.5.9.1943.

Reference Type: BACKGROUND

PMID: 15330732 (View on PubMed)

Other Identifiers

R01AA013964

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAAAJOH1052207A1

Identifier Type: -

Identifier Source: org_study_id