Clinical Trial of Topiramate for Cocaine Addiction
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders; Behavior, Addictive
Intervention: topiramate; Contingency Reinforcement; placebo + NonCR
Intervention description: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial; monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results; participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence
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: 250.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: addiction; drug dependence; stimulant

Summary:

      This is an outpatient clinical trial of topiramate for addressing cocaine dependence and
      reduction of cocaine associated behaviors in opiate dependent drug users maintained on
      methadone treatment.

      The study aims to answer whether topiramate

        1. is safe and acceptable to methadone patients

        2. reduces cocaine use

        3. helps with collateral problems such as alcohol abuse, tobacco dependence, anxiety, PTSD
           and/or pain symptoms. The study will also evaluate topiramate effect on neuro-cognitive
           performance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 - 55 years old

          -  active opioid and cocaine dependence

          -  seeking treatment for cocaine and opioid dependence

          -  eligible for methadone maintenance per state and federal regulations

          -  able and willing to provide a urine sample thrice a week

          -  willing to answer questionnaires on a weekly basis

          -  willing to provide breath samples for presence of alcohol thrice weekly

          -  fluent in the English language

        Exclusion Criteria:

          -  allergy to sulfonamide drugs

          -  diabetes, respiratory insufficiency, renal tubular acidosis, renal insufficiency,
             heart failure, liver insufficiency, chronic diarrhea, other chronic diseases
             predisposing to a risk of acidosis

          -  history of nephrolithiasis

          -  HIV positive individuals who meet AIDS criteria by CDC criteria or are taking
             antiretroviral medications

          -  serious psychiatric illness (psychosis, dementia)

          -  glaucoma or family history of glaucoma

          -  prostate hyperplasia, shy bladder, irritable bladder, difficulty providing urine
             samples on demand

          -  female participants: being pregnant, lactating, or unwilling to use an effective
             method of contraception

          -  use of antiepileptic agents

          -  benzodiazepine dependence

          -  latex allergy