Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

Alcoholism Clinical Trial

Official title:

Combining Medications Treatment for Alcoholism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00006205
• Other study ID #: NIAAAJOH1052207A1
• Secondary ID: R01AA013964
• Status: Recruiting
• Phase: Phase 2
• First received: September 11, 2000
• Last updated: March 14, 2013
• Start date: March 2005
• Est. completion date: December 2013

Study information

• Verified date: March 2013
• Source: University of Virginia
• Contact: Mindy Borszich
• Phone: 1-888-882-2345
• Email: mcb3x[@]virginia.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• ondansetron + cognitive behavioral therapy
ondansetron (4 mcg/kg b.i.d)
• topiramate + cognitive behavioral therapy
topiramate (up to 300 mg/day)
• Placebo + cognitive behavioral therapy
placebo
• ondansetron + topiramate + cognitive behavioral therapy
ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)

Locations

Country	Name	City	State
United States	University of Virginia Center for Addiction Research and Education	Charlottesville	Virginia
United States	University of Virginia Center for Addiction Research and Education	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Bankole Johnson	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption	Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT	Throughout the study	No
Secondary	Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors	Pill Count, Q-LES-Q, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM	Throughout the study	Yes

External Links

•   (UVA CARE Website)