Combination Therapy With Modafinil and Escitalopram for the Treatment of Cocaine Dependence

NCT01601730 Phase 1 COMPLETED

The purpose of this study is to improve the efficacy of modafinil as a potential treatment for cocaine dependence.

Details

Lead sponsor	Baylor College of Medicine
Phase	Phase 1
Status	COMPLETED
Enrolment	68
Start date	2010-08
Completion	2011-07

Conditions

• Cocaine Dependence
• Cocaine Abuse
• Cocaine Addiction
• Substance Abuse

Interventions

• Modafinil and Escitalopram
• Placebo
• Modafinil
• Escitalopram

Primary outcomes

• The effects of modafinil and/or escitalopram and cocaine on cardiovascular measures
  Before and after each cocaine infusion, physiologic responses will be closely monitored using repeated HR, BP, and ECG readings. To evaluate safety, a DSMB will meet annually and following any serious AE to examine data as well as any new published information on modafinil and/or escitalopram relevant to the project. The number of AEs (including arrhythmias and ECG changes), changes in BP and HR, changes in cocaine PKs, and changes in mood and psychiatric symptoms (using the BSI, BDI, POMS, and BPRS) will also be assessed throughout the study.

Countries

United States