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Effectiveness of Topiramate in Treating Cocaine Dependent Individuals - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00249691
Recruitment Status : Unknown
Verified March 2012 by Bankole Johnson, University of Virginia.
Recruitment status was:  Active, not recruiting
First Posted : November 7, 2005
Last Update Posted : March 8, 2012
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Bankole Johnson, University of Virginia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: Topiramate + Cognitive Behavioral Therapy Drug: Placebo + Cognitive Behavioral Therapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medication Development for Cocaine Dependence
Study Start Date : October 2005
Actual Primary Completion Date : October 2011
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Topiramate Drug: Topiramate + Cognitive Behavioral Therapy
Topiramate up to 300 mg per day
Other Name: Topamax

Placebo Comparator: Placebo Drug: Placebo + Cognitive Behavioral Therapy
Placebo twice a day
Other Name: Sugar Pill

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00249691

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United States, Virginia
Charlottesville, Virginia, United States, 22911
UVA CARE Richmond
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Bankole Johnson
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Bankole Johnson University of Virginia
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bankole Johnson, Chair of Psychiatry and Neurobehavioral Sciences, University of Virginia Identifier: NCT00249691    
Other Study ID Numbers: 11578
R01DA017296 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012
Keywords provided by Bankole Johnson, University of Virginia:
cocaine addiction
cocaine dependence
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Hypoglycemic Agents
Physiological Effects of Drugs