Effectiveness of Topiramate in Treating Cocaine Dependent Individuals - 1 - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	University of Virginia
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00249691

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	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Efficacy Study
Official Title:	Medication Development for Cocaine Dependence

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride Topiramate

U.S. FDA Resources

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

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 2011
Estimated Primary Completion Date:	October 2010 (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:

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
Seeking treatment for cocaine dependence
At least one positive urine drug screen, within the 2 weeks prior to study entry
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
Organic brain disease
Dementia
Bulimia and/or anorexia nervosa
Seizure disorders or epilepsy
History of suicide attempts and/or current suicidal ideation, as determined by the SCID, within the 30 days prior to study entry
Mandated by the court to obtain treatment for cocaine dependence
Expected to relocate from the study area
AIDS diagnosis, or a CD4 cell count less than 500 mm
Active or history of syphilis
Severe or life-threatening adverse reaction to any medications the year prior to study entry
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 pharmacotherapy with psychotropics, including antidepressants, anxiolytics, antipsychotics, anticonvulsants, and psychomotor stimulant-type medications, within the two weeks prior to study entry
Use of St. John's Wort, yohimbine, ginko biloba, horehound, or any other central nervous system active herbal preparations within the 2 weeks prior to study entry
Use of any opiate substitutes (e.g., methadone, levo-alpha acetyl methadol, buprenorphine), within the month prior to study entry
Clinically significant test results that, in the investigator's opinion, may interfere with study participation
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

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

Contacts

Contact: Mindy Borszich

(434)243-0549

mcb3x@virginia.edu

Locations

United States, Virginia
UVA CARE	Recruiting
Charlottesville, Virginia, United States, 22911
Contact: MIndy Borszich 434-243-0549 mcbx@virginia.edu
UVA CARE Richmond	Recruiting
Richmond, Virginia, United States, 23294

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

University of Virginia

Investigators

Principal Investigator:

Bankole Johnson

University of Virginia

More Information

Additional Information:

UVA CARE website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Virginia ( Bankole Johnson, DSc, M.D., Ph.D. )
Study ID Numbers:	NIDA-17296-1, R01-17296-1, DPMC
Study First Received:	November 3, 2005
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00249691 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):

cocaine addiction
cocaine dependence

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Disorders of Environmental Origin
Anesthetics
Neuroprotective Agents
Mental Disorders
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Substance-Related Disorders

Topiramate
Cocaine
Cocaine-Related Disorders
Central Nervous System Depressants
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Anesthetics, Local
Anti-Obesity Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 30, 2009