NCT00448825

Brief Summary

The purpose of this study is to evaluate the effects of Topiramate and Cognitive Behavioral Therapy for the treatment of alcohol and cocaine dependence.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2007

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

March 15, 2013

Status Verified

March 1, 2013

Enrollment Period

6.3 years

First QC Date

March 15, 2007

Last Update Submit

March 14, 2013

Conditions

Alcohol DependenceCocaine Dependence

Keywords

alcohol dependencealcoholismcocaine addictioncocaine dependence

Outcome Measures

Primary Outcomes (1)

  • The topiramate group will be superior to the placebo group on the following outcome measures:increasing the weekly mean proportion of cocaine-free days, decreasing self-reported drinking, and decreasing craving for cocaine and alcohol.

    Alcohol - assessed by self-report of use (TLFB,DD,DDD,PDA, PHDD), biochemical markers (GGT, CDT), OCDS Cocaine - assessed by self-report of use (CTFB, substance use inventory, QFI),urine assay for benzoylecgonine, and CCQ-NOW

    According to Preston Rules from weeks 6 to 12.

Secondary Outcomes (1)

  • a. Cocaine free weeks; b. Topiramate, compared with placebo, will be associated with an improvement in psychosocial functioning as exemplified by improved general well-being, social functioning, and quality of life.

    According to Preston Rules from weeks 1 to 12

Study Arms (2)

Topiramate

EXPERIMENTAL

Topiramate + Cognitive Behavioral Therapy

Drug: Topiramate + Cognitive Behavioral Therapy

Placebo

PLACEBO COMPARATOR

Placebo + Cognitive Behavioral Therapy

Drug: Placebo + Cognitive Behavioral Therapy

Interventions

Topiramate + Cognitive Behavioral TherapyDRUG

Topiramate up to 300 mg per day

Also known as: Topamax
Topiramate
Placebo + Cognitive Behavioral TherapyDRUG

Placebo twice a day

Also known as: Sugar Pill
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will be men and women between the ages of 18 years and older.
  • Must meet at least three of the seven DSM IV diagnostic criteria for alcohol and cocaine dependence.
  • Express a desire for treatment.
  • Literacy in English and ability to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments are required.
  • Prospective subjects must report cocaine use of at least once per month and alcohol consumption of ≥21 drinks/week and ≥14 drinks/week for men and women respectively, during the past 30 days
  • At least one positive urine drug screen for cocaine at screen or baseline prior to randomization.

You may not qualify if:

  • Please contact site for additional information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Virginia Center for Addiction Research and Education

Charlottesville, Virginia, 22911, United States

RECRUITING

University of Virginia Center for Addiction Research and Education

Richmond, Virginia, 23294, United States

RECRUITING

MeSH Terms

Conditions

AlcoholismCocaine-Related Disorders

Interventions

TopiramateCognitive Behavioral TherapySugars

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesCarbohydratesKetosesBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Bankole Johnson, DSc, MD, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mindy Borszich

CONTACT

1-888-882-2345mcb3x@virginia.edu

Eva Jenkins-Mendoza

CONTACT

(434)243-0562emj9c@virginia.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chair of Psychiatry and Neurobehavioral Sciences

Study Record Dates

First Submitted

March 15, 2007

First Posted

March 19, 2007

Study Start

March 1, 2007

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

March 15, 2013

Record last verified: 2013-03

Locations

US(2)