drugset / Trial / NCT01811940
Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence
Phase 2/3
Completed
169 enrolled
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The proposed protocol is a multi-site double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (MAS-ER) and topiramate in the treatment of cocaine dependence. 198 patients will be enrolled and 176 patients randomized in a 14-week trial. The proportion of participants achieving sustained cocaine abstinence for three consecutive weeks at the end of the study will be significantly greater for the combined pharmacotherapies group compared to the placebo group.
Timeline
- Start
- 2013-07
- Primary completion
- 2017-06
- Completion
- 2017-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adderall-ER | Unknown | 60 mg | — |
| Subject | Topiramate | Small molecule | 100 mg | — |