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Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

Combining Medications Treatment for Alcoholism

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00006205
Enrollment
320
Registered
2000-09-12
Start date
2005-03-31
Completion date
2013-12-31
Last updated
2013-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism

Keywords

alcoholism, alcohol addiction

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.

Interventions

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

topiramate (up to 300 mg/day)

DRUGondansetron + topiramate + cognitive behavioral therapy

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

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Bankole Johnson
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumptionThroughout the studyDrinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT

Secondary

MeasureTime frameDescription
Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factorsThroughout the studyPill Count, Q-LES-Q, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM

Countries

United States

Contacts

Primary ContactMindy Borszich
mcb3x@virginia.edu1-888-882-2345
Backup ContactEva Jenkins-Mendoza
emj9c@virginia.edu(434) 243-0562

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026