Purpose

The 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.

Type of Study: Clinical Trial
Setting of Study: outpatient
Clinical Trials.gov number: NCT00421603
Providing Clinical Treatment?: Yes
No Cost Treatment?: Yes
Care is provided in languages: English

Study Activities

Filling Out Forms
Computer Tasks
Blood Samples
Psychophysiology measurements
Provides Payment: Reimbursement for transportation
Provides Payment: Compensation for study related procedures

Eligibility

Ages Eligible for Study: 18 Years - 60 Years
Genders Eligible for Study: Both
This study is not recruiting Healthy Volunteers.

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.



Links
Drug treatment and research service. Treating marijauna, cocaine and opiate addiction.

Location: 513 west 166th street STARS-3rd floor New York, NY 10032
Clinic: Substance Treatment and Research Services
Division: Substance Abuse

Study chairs or principal investigators:
Frances Rudnick Levin M.D., Principal Investigator

Co-investigators:
adam bisaga,
john mariani,