Effectiveness of Topiramate in Treating Cocaine Dependent Individuals - 1

March 6, 2012 updated by: Bankole Johnson

Medication Development for Cocaine Dependence

Although a great amount of research has been conducted to resolve cocaine dependence, an effective treatment has yet to be discovered. Topiramate is a drug that was found to be useful in treating alcohol dependence. The purpose of this study is to determine the effectiveness of topiramate in treating cocaine dependent individuals.

Study Overview

Detailed Description

Despite considerable scientific effort in the last two decades to develop treatment for cocaine dependent individuals, no medication has proven to be effective for treating cocaine dependence. Cocaine's rewarding effects are primarily a result of altering nerve pathways involving dopamine, a naturally-occurring chemical in the brain. Past research has focused on developing medications that either block dopamine or inhibit its release. However, these medications have not proven effective in treating cocaine dependence. This study will evaluate a new strategy of treating cocaine dependence by altering dopamine's functional expression. Dopamine-associated expression may be mediated through inhibition of gamma-aminobutyric acid (GABA), another brain chemical. Topiramate is a GABA inhibitor that has proven effective in treating alcohol dependent individuals. The purpose of this study is to determine the efficacy of topiramate in treating cocaine dependent individuals.

Participants 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, and will include evaluations of cocaine use and psychosocial functioning.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • UVA CARE
      • Richmond, Virginia, United States, 23294
        • UVA CARE Richmond

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current DSM-IV diagnosis of cocaine dependence
  • Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters
  • Seeking treatment for cocaine dependence
  • At least one positive urine drug screen for cocaine at screen or baseline prior to randomization
  • If female, a negative pregnancy test prior to study entry
  • Agrees to use an effective method of contraception for the duration of the study
  • Reads and writes English
  • Willing to participate in behavioral treatment for cocaine dependence

Exclusion Criteria:

  • Current DSM-IV diagnosis of dependence on any psychoactive substance other than cocaine, alcohol, nicotine, caffeine, or marijuana
  • Physiological dependence on alcohol and requires medical detoxification
  • Neurological or psychiatric disorders
  • Any Axis 1 disorder that warrants treatment or would preclude safe participation
  • Organic brain disease
  • Dementia
  • Bulimia and/or anorexia nervosa
  • Seizure disorders or epilepsy
  • Any disorder which would require ongoing treatment or which would make study agent compliance difficult
  • History of suicide attempts and/or current suicidal ideation, as determined by the SCID, within the 30 days prior to screening
  • Serious medical illnesses
  • Mandated by the court to obtain treatment for cocaine dependence
  • Expected to relocate from the study area
  • AIDS diagnosis
  • HIV with a CD4 positive T cell count less than 500 mm
  • Any subjects on any pharmacotherapy for the treatment of AIDS or HIV will be excluded
  • Active syphilis that has not been treated, or refused treatment for syphilis
  • Severe or life-threatening adverse reactions to medications (including topiramate) in the past or during this clinical trial
  • Currently receiving active treatment with topiramate
  • Use of a drug with known potential for toxicity to a major organ system (e.g., isoniazid, methotrexate), within 30 days prior to study entry
  • Pregnant or breastfeeding
  • Concurrent regular use of psychotropics, including but not limited to antidepressants, anxiolytics, antipsychotics, anticonvulsants, and psychomotor stimulant-type medications, St. John's Wort, yohimbine, ginko biloba, horehound, or any other central nervous system active herbal preparations
  • Use of any opiate substitutes (e.g., methadone, levo-alpha acetyl methadol, buprenorphine), within the month prior to screening
  • Clinically significant test results that, in the investigator's opinion, require immediate or urgent treatment
  • Fever of unknown origin or neuroleptic malignant syndrome
  • Serious medical co-morbidity requiring medical intervention or close supervision
  • Received inpatient or outpatient treatment for cocaine dependence within the 4 weeks prior to study entry
  • Past participation in a clinical trial utilizing topiramate
  • Treatment with electroconvulsive therapy within the 3 months prior to study entry
  • Member of the same household of an individual enrolled in the present study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo twice a day
Other Names:
  • Sugar Pill
Experimental: Topiramate
Topiramate up to 300 mg per day
Other Names:
  • Topamax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effectiveness of topiramate to reduce cocaine use(assessed by a combination of self-report of use and urine assays for benzoylecgonine, the major metabolite of cocaine).
Time Frame: Throughout the study (Visit 0 to Visit 12, and at 2 weeks, 1, 2, and 3 months following completion of treatment)
Throughout the study (Visit 0 to Visit 12, and at 2 weeks, 1, 2, and 3 months following completion of treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
Improved psychosocial functioning; measured throughout the study, and at 2 weeks and 1, 2, and 3 months following completion of treatment
Time Frame: measured throughout the study, and at 2 weeks and 1, 2, and 3 months following completion of treatment
measured throughout the study, and at 2 weeks and 1, 2, and 3 months following completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Bankole Johnson, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

October 1, 2011

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

November 3, 2005

First Submitted That Met QC Criteria

November 3, 2005

First Posted (Estimate)

November 7, 2005

Study Record Updates

Last Update Posted (Estimate)

March 8, 2012

Last Update Submitted That Met QC Criteria

March 6, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 11578
  • DPMC (Other Identifier: NIDA)
  • R01DA017296 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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