Topiramate for Alcohol and Cocaine Dependence
Condition: Alcoholism; Cocaine Dependence
MeSH terms: Alcoholism; Cocaine-Related Disorders
Intervention: Topiramate; placebo
Intervention description: 300mg/day for 13 weeks; placebo pills
Intervention MeSH terms: Topiramate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Topiramate; alcoholism; cocaine dependence

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and females, 18 years or older.

          -  Meets DSM(Diagnostic and Statistical Manual)-IV criteria for current diagnoses of
             cocaine and alcohol dependence, determined by the SCID (Structured Clinical Interview
             for the DSM)-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.

          -  Two 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,. Subjects will be
             encouraged to achieve 3 consecutive days of abstinence, however, subjects who have
             achieved 2 consecutive days of abstinence will be included with the approval of the
             principal investigator. We anticipate that these subjects will comprise less than 5%
             of total enrolled subjects. Subjects will be given 2 additional weeks beyond the
             screening week to attain the appropriate period of cocaine and alcohol abstinence
             prior to randomization.

          -  Lives a commutable distance from the Treatment Research Center (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 and cannabis), determined by the SCID.

          -  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 schizophrenia or any psychotic disorder, or organic mental
             disorder. Subject meets current DSM-IV diagnosis of any other clinically significant
             psychiatric disorder that will interfere with study participation.

          -  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 milliequivalent (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.

          -  A history of glaucoma