Effectiveness of Topiramate in Treating Cocaine Dependent Individuals - 1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Virginia.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bankole Johnson, University of Virginia
ClinicalTrials.gov Identifier:
NCT00249691
First received: November 3, 2005
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Cocaine-Related Disorders
Drug: Topiramate + Cognitive Behavioral Therapy
Drug: Placebo + Cognitive Behavioral Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medication Development for Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: October 2005
Estimated Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249691

Locations
United States, Virginia
UVA CARE
Charlottesville, Virginia, United States, 22911
UVA CARE Richmond
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Bankole Johnson
Investigators
Principal Investigator: Bankole Johnson University of Virginia
  More Information

Additional Information:
No publications provided by University of Virginia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bankole Johnson, Chair of Psychiatry and Neurobehavioral Sciences, University of Virginia
ClinicalTrials.gov Identifier: NCT00249691     History of Changes
Other Study ID Numbers: 11578, R01DA017296, DPMC
Study First Received: November 3, 2005
Last Updated: March 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
cocaine addiction
cocaine dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Topiramate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Anticonvulsants
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents

ClinicalTrials.gov processed this record on August 28, 2014