Effectiveness of Topiramate in Treating Cocaine Dependent Individuals - 1

Condition(s) targeted: Cocaine-Related Disorders

Intervention: Topiramate (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Bankole Johnson, Principal Investigator, Affiliation: University of Virginia

Overall contact:
Mindy Borszich, Phone: (434)243-0549, Email: mcb3x@virginia.edu

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.

Official title: Medication Development for Cocaine Dependence

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Efficacy Study

Primary outcome: 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).

Secondary outcome: Improved psychosocial functioning; measured throughout the study, and at 2 weeks and 1, 2, and 3 months following completion of treatment

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Mindy Borszich, Phone: (434)243-0549, Email: mcb3x@virginia.edu

UVA CARE, Charlottesville, Virginia 22911, United States; Recruiting
MIndy Borszich, Phone: 434-243-0549, Email: mcbx@virginia.edu

UVA CARE Richmond, Richmond, Virginia 23294, United States; Recruiting

UVA CARE website

Starting date: October 2005
Ending date: October 2011
Last updated: August 5, 2008