A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Adderall-XR and Topiramate; Placebo
Intervention description: Adderall-XR 60mg/day and Topiramate 300mg/day; Placebo
Intervention MeSH terms: Topiramate; Adderall
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Cocaine; Adderall; Topiramate; ADHD

Summary:

      The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety
      and efficacy of Adderall-XR (ER-MAS) and topiramate in the treatment of cocaine dependence.
      Since both of these medications have independently shown promise in helping with cocaine
      abuse we are proposing that together they may be even more successful in the treatment of
      cocaine abuse. We plan to enroll 120 subjects in a 14-week trial. The primary objective of
      the study is to determine the efficacy of ER-MAS and topiramate in promoting cocaine
      abstinence among cocaine-dependent patients. This study includes free treatment for cocaine
      dependence that includes medication.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women between the ages of 18-60 who meet DSM-IV criteria for current cocaine
             dependence (DSM-IV-TR).

          2. Used cocaine at least four days in the past month, with at least weekly cocaine use.

          3. Must have a Body Mass Index (BMI) > 18 kg/m2

          4. Alcohol Breathalyzer (BraC) at consent of < 0.04%

          5. Individuals must be capable of giving informed consent and capable of complying with
             study procedures.

          6. Women of child bearing age will be included in the study provided that they are not
             pregnant, based on the results of a blood pregnancy test drawn at the time of
             screening. They must also agree to use a method of contraception with proven efficacy
             and agree not to become pregnant during the study. To confirm this, blood pregnancy
             tests will be repeated monthly. Women will be provided a full explanation of the
             potential dangers of pregnancy while on the study medication. If a woman becomes
             pregnant, the study medication will be discontinued.

        Exclusion Criteria:

          1. Meets DSM-IV-TR criteria for bipolar disorder, Schizophrenia, or any psychotic
             disorder other than transient psychosis due to drug abuse

          2. Individuals with any current Axis I psychiatric disorder as defined by DSM-IV-TR
             supported by the SCID-I/P that in the investigator's judgment are unstable or would be
             disrupted by study medication or are likely to require pharmacotherapy during the
             study period.

          3. Individuals with current major depressive disorder.

          4. Individuals physiologically dependent on any other drugs (excluding nicotine or
             cannabis) which require medical intervention.

          5. Individuals with current psycho stimulant abuse or dependence.

          6. Individuals with current suicidal risk.

          7. Individuals with coronary vascular disease as indicated by history or suspected by
             abnormal ECG or history of cardiac symptoms.

          8. Unstable physical disorders which might make participation hazardous such as
             uncontrolled hypertension (SBP > 150, DBP> 90, or HR > 100 when sitting quietly),
             acute hepatitis (patients with chronic mildly elevated transaminases < 3x upper limit
             of normal are acceptable), or uncontrolled diabetes.

          9. Individuals with a history of seizures

         10. History of allergic reaction to candidate medication (amphetamine and/or ER-MAS or
             topiramate).

         11. Women who are pregnant or nursing.

         12. Use of carbonic anhydrase inhibitors*

         13. History of glaucoma, kidney stones*

         14. History of failure to respond to a previous Adequate trial of either candidate
             medication for Cocaine dependence

         15. Currently being prescribed psychotropic medication by another physician (other than
             sleep medication)

         16. Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other
             penalties, etc.) to participate in substance abuse treatment program -