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Novel Pharmacotherapy for Dual Dependence

Primary Purpose

Alcohol Dependence, Cocaine Dependence

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Topiramate + Cognitive Behavioral Therapy
Placebo + Cognitive Behavioral Therapy
Sponsored by
Bankole Johnson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring alcohol dependence, alcoholism, cocaine addiction, cocaine dependence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

Please contact site for additional information

Sites / Locations

  • University of Virginia Center for Addiction Research and EducationRecruiting
  • University of Virginia Center for Addiction Research and EducationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Topiramate

Placebo

Arm Description

Topiramate + Cognitive Behavioral Therapy

Placebo + Cognitive Behavioral Therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Cocaine free weeks is assessed by a combination of self-report of use and urine assays; Assessed by increased scores in the following assessments: CGI, BSI, Q-LES-Q, DrInC, SFQ, medication compliance, CIWA-Ar, POMS, BIS

Full Information

First Posted
March 15, 2007
Last Updated
March 14, 2013
Sponsor
Bankole Johnson
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00448825
Brief Title
Novel Pharmacotherapy for Dual Dependence
Official Title
Novel Pharmacotherapy for Dual Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bankole Johnson
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Our objective is to understand the basic mechanisms that underpin substance dependence, and to develop efficacious treatments for individuals with comorbid cocaine and alcohol dependence. Participants in this study will be randomly assigned to receive either 300 mg per day of topiramate or placebo. In addition, participants will receive weekly cognitive behavioral therapy for 12 weeks.Follow-up visits will occur at 2 weeks and 1,2,, and 3 months following completion of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Cocaine Dependence
Keywords
alcohol dependence, alcoholism, cocaine addiction, cocaine dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topiramate
Arm Type
Experimental
Arm Description
Topiramate + Cognitive Behavioral Therapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + Cognitive Behavioral Therapy
Intervention Type
Drug
Intervention Name(s)
Topiramate + Cognitive Behavioral Therapy
Other Intervention Name(s)
Topamax
Intervention Description
Topiramate up to 300 mg per day
Intervention Type
Drug
Intervention Name(s)
Placebo + Cognitive Behavioral Therapy
Other Intervention Name(s)
Sugar Pill
Intervention Description
Placebo twice a day
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
According to Preston Rules from weeks 6 to 12.
Secondary Outcome Measure Information:
Title
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.
Description
Cocaine free weeks is assessed by a combination of self-report of use and urine assays; Assessed by increased scores in the following assessments: CGI, BSI, Q-LES-Q, DrInC, SFQ, medication compliance, CIWA-Ar, POMS, BIS
Time Frame
According to Preston Rules from weeks 1 to 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Please contact site for additional information
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mindy Borszich
Phone
1-888-882-2345
Email
mcb3x@virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Jenkins-Mendoza
Phone
(434)243-0562
Email
emj9c@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bankole Johnson, DSc, MD, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Center for Addiction Research and Education
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mindy Borszich
Phone
888-882-2345
Email
mcb3x@virginia.edu
First Name & Middle Initial & Last Name & Degree
Eva Jenkins-Mendoza
Phone
(434)243-0562
Email
emj9c@virginia.edu
First Name & Middle Initial & Last Name & Degree
Bankole Johnson, DSc,MD,PhD
First Name & Middle Initial & Last Name & Degree
Nassima Ait-Daoud, MD
Facility Name
University of Virginia Center for Addiction Research and Education
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mindy Borszich
Phone
888-882-2345
Email
mcb3x@virginia.edu
First Name & Middle Initial & Last Name & Degree
Eva Jenkins-Mendoza
Phone
(434)243-0562
Email
emj9c@virginia.edu
First Name & Middle Initial & Last Name & Degree
Bankole Johnson, DSc,MD,PhD
First Name & Middle Initial & Last Name & Degree
Nassima Ait-Daoud, MD

12. IPD Sharing Statement

Learn more about this trial

Novel Pharmacotherapy for Dual Dependence

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