Official Title: “A Phase II, Randomized, Double-Blind, Placebo-Controlled, Pilot Trial of Topiramate for Alcohol and Comorbid Cocaine Dependence”

The primary purpose of this study is to test the effectiveness of topiramate for the treatment of combined alcohol and cocaine dependence. Topiramate is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2009

The purpose of this study is to evaluate the efficacy of 300 mg/day of topiramate for the treatment of 200 treatment-seeking alcohol dependent outpatients with comorbid cocaine dependence in a double-blind, placebo-controlled 14-week trial, with a 6-month follow-up (3months after completing medications).

Intervention(s) in this Clinical Trial

• Drug: Topiramate
  • 300mg/day for 13 weeks
• Drug: placebo
  • placebo pills

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Group 1
  • topiramate
• Placebo Comparator: Group 2

Primary Measures

• Days abstinent from drinking and frequency of heavy drinking days as measured by the Time Line Follow-Back
  • Time Frame: 14 weeks
    Safety Issue?: No
• Fewer days of cocaine use as measured by the Time Line Follow Back and confirmed by urine drug screen.
  • Time Frame: 14 weeks
    Safety Issue?: No

Inclusion Criteria:

• Male and females, 18-70 years old.
• Meets DSM-IV criteria for current diagnoses of cocaine and alcohol dependence, determined by the SCID-IV.
• In the past 30 days, used no less than $200-worth of cocaine and meets the following drinking criteria as measured by the Timeline Followback (TLFB) (Sobell and Sobell, 1995) a. drank within 30 days of intake day, b. reports a minimum of 48 standard alcoholic drinks (avg. 12 drinks/wk) in a consecutive 30-day period over the 90-day period prior to starting intake (i.e., a minimum of 40% days drinking), and c. has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males and 4 or more drinks per day in females) in this same pre-treatment period.
• Three consecutive days of abstinence from cocaine and alcohol, determined by self-reports and confirmed by negative urine toxicology screens, a negative breathalyzer tests, and collateral report, a Clinical Institute Withdrawal Scale for
• Alcohol (CIWA-AR) (Sullivan et al., 1989) score below eight,.
• Lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits.
• Speaks, understands, and prints in English.

Exclusion Criteria:

• Abstinent from cocaine or alcohol for 30 consecutive days prior to signing consent form.
• Meets DSM-IV criteria for dependence on any substance other than cocaine and alcohol (except nicotine), determined by the SCID. Subjects who test positive on the urine drug screen (with the exception of cocaine) in the week prior to the randomization visit will be excluded (only one repeat testing permitted).
• Needs treatment with any psychoactive medications including any anti-seizure medications (with the exception of Benadryl used sparingly, if necessary, for sleep).
• Current use of phenytoin or any drug of similar class.
• Meets DSM-IV criteria for the following current Axis I disorders: panic, obsessive-compulsive, post-traumatic stress, or eating disorders. Subjects who meet current or lifetime DSM-IV criteria for schizophrenia or any psychotic disorder, or organic mental disorder.
• Has evidence of a history of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease.
• Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels (>1.3), or elevated levels (over 3.5x normal) of aspartate aminotransferase (AST), and serum glutamic-pyruvic transaminase (SGPT) after the required 3 days of abstinence, or severe renal disease, severe respiratory diseases or severe diarrhea with resulting metabolic acidosis, serum bicarbonate (< 20 mEq/L)
• History of epilepsy or seizure disorder.
• Use of an investigational medication in the 30 days prior to randomization.
• History of nephrolithiasis (kidney stones).
• History of hypersensitivity to topiramate.
• Is female and tests positive on a pregnancy test, is contemplating pregnancy in the next 6 months, is nursing, or is not using an effective contraceptive method (if relevant). Acceptable methods of contraception include barrier methods (diaphragm or condom with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, and medroxyprogesterone acetate contraceptive injection).
• Current use of a carbonic anhydrase inhibitor.
• Current use of an oral contraceptive.
• A history of glaucoma

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pennsylvania

Overall Clinical Trial Officials and Contacts

Kyle M Kampman, MD Principal Investigator University of Pennsylvania  

Overall Contact: Kyle M Kampman, MD 215-222-3200 kampman_k@mail.trc.upenn.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00167245

Study ID Number: 801385

ClinicalTrials.gov Identifier: NCT00167245

Health Authority: United States: Food and Drug Administration