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Novel Pharmacotherapy for Dual Dependence
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), April 2009
First Received: March 15, 2007   Last Updated: April 29, 2009   History of Changes
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
University of Virginia
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00448825
  Purpose

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


Condition Intervention Phase
Alcohol Dependence
Cocaine Dependence
Drug: Topiramate
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title: Novel Pharmacotherapy for Dual Dependence

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

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 and decreasing self-reported drinking. [ Time Frame: Throughout the study (Visit 0 to Visit 12, and at 2 weeks, 1, 2, and 3 months following completion of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Measured throughout the study, and at 2 weeks and 1,2, and 3 months following completion of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: March 2007
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Topiramate: Experimental Drug: Topiramate
Topiramate up to 300 mg per day
Placebo: Placebo Comparator Drug: Topiramate
Topiramate up to 300 mg per day

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 within the two-week baseline prior to randomization with a minimum of four samples tested.

Exclusion Criteria:

  • Individuals likely to require hospitalization for severe medical complications or surgery, or those whose severity of illness precludes utilization of the behavioral treatments.
  • Women who are pregnant, breastfeeding, or unwilling to use effective birth control to prevent becoming pregnant during the study
  • Certain physical or psychiatric conditions that would compromise participation
  • Current dependence, defined by DSM-IV criteria, on any psychoactive substance other than cocaine, alcohol, nicotine, caffeine, or marijuana or physiological dependence on alcohol requiring medical detoxification.
  • Mandated by court to obtain treatment for alcohol and/or cocaine dependence.
  • Elevation of liver enzymes (SGOT), serum glutamic pyruvic transaminase (SGPT), blood urea nitrogen (BUN), or lactate dehydrogenase (LDH).
  • Anyone who, in the opinion of the investigator, would not be expected to complete the study protocol because of probable incarceration or relocation from the clinic area.
  • Severe or life-threatening adverse reactions to topiramate in the past or during this clinical trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448825

Contacts
Contact: Mindy Borszich, BA 1-888-882-2345 uvacare@virginia.edu

Locations
United States, Virginia
UVA CARE Recruiting
Charlottesville, Virginia, United States, 22911
Principal Investigator: Bankole Johnson, DSc,MD,PhD            
Sub-Investigator: Nassima Ait-Daoud, MD            
UVA CARE Richmond Recruiting
Richmond, Virginia, United States, 23294
Principal Investigator: Bankole Johnson, DSc,MD,PhD            
Sub-Investigator: Nassima Ait-Daoud, MD            
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Bankole Johnson, DSc, MD, PhD University of Virginia
  More Information

Additional Information:
No publications provided

Responsible Party: University of Virginia ( Bankole Johnson, DSc, M.D., Ph.D. )
Study ID Numbers: 1 R01 DA019804-01A1, R01 DA019804, DPMCDA
Study First Received: March 15, 2007
Last Updated: April 29, 2009
ClinicalTrials.gov Identifier: NCT00448825     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
alcohol dependence
alcoholism
cocaine addiction
cocaine dependence

Study placed in the following topic categories:
Cocaine-Related Disorders
Behavior, Addictive
Disorders of Environmental Origin
Neuroprotective Agents
Anti-Obesity Agents
Mental Disorders
Alcoholism
Substance-Related Disorders
Topiramate
Alcohol-Related Disorders
Cocaine
Anticonvulsants
Ethanol

Additional relevant MeSH terms:
Cocaine-Related Disorders
Physiological Effects of Drugs
Disorders of Environmental Origin
Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Anti-Obesity Agents
Mental Disorders
Therapeutic Uses
Alcoholism
Substance-Related Disorders
Topiramate
Alcohol-Related Disorders
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on September 02, 2009