NCT01811940

Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators hypothesize that the combination of an agent that increased baseline dopamine signaling (amphetamine) with one that reduced cocaine-induced dopamine release (topiramate) will improve dopamine regulation and be associated with improved cocaine use outcomes. 99 subjects at each of the two sites whom meet criteria for cocaine dependence, and all other study inclusion and exclusion criteria will be assigned to the 14-week double-blind, placebo-controlled treatment trial. Subjects will be randomized to receive either placebo or MAS-ER and topiramate. This proposal will test the hypothesis that MAS-ER and topiramate will promote cocaine abstinence. Participants who are randomized to the combination medication arm will have their dose titrated to 60 mg MAS-ER daily (over 2 weeks) and 200 mg topiramate a day (over 6 weeks) and maintained on this dose through week 13 of the trial. During week 14, participants will be tapered off both medications. All participants will receive a supportive behavioral treatment that emphasizes study procedure adherence. Starting in week one, all patients will receive incentives for compliance with study procedures on an escalating reinforcement schedule similar to that developed previously and not contingent on urine results. The purpose of the lead-out is to blind patients to the exact point of medication discontinuation and to provide naturalistic data on the effects of medication discontinuation. Moreover, a 3 month follow-up will be conducted to determine what happens to cocaine use after treatment discontinuation.

Conditions

• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Adderall-ER	MAS-ER 60mg/day
DRUG	Topiramate	Topiramate 100 mg bid.
OTHER	Placebo	Placebo

Timeline

• Start date: 2013-07-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2013-03-15
• Last updated: 2019-04-24
• Results posted: 2018-10-12

Locations

2 sites across 1 country: United States