drugset / Trial / NCT02538744

Complementary Combination Therapy for Cocaine Dependence

NCT02538744

Phase 1 Completed 45 enrolled Baylor College of Medicine
RandomizedParallel-groupDouble-blindTreatment

Summary

The investigators will assess the impact of treatment with doxazosin and modafinil, alone and in combination, on the subjective and reinforcing effects of cocaine in non-treatment-seeking, cocaine-dependent volunteers. The investigators will use a hybrid design in which participants will be randomized into two groups: placebo and doxazosin 8 mg/d. They will remain in their assigned group for the duration of the study. After titrating doxazosin to the target dose, study procedures will be completed three times, once during treatment with each dose of modafinil (0, 200, and 300 mg/d), in pseudo-random order such that 200 mg precedes 300 mg).

Timeline

Start
2015-08
Primary completion
2018-08-21
Completion
2018-08-21

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cocaine Small molecule 20 mg Intravenous
Comparator Cocaine Small molecule 40 mg Intravenous
Comparator Doxazosin Small molecule 8 mg Oral
Comparator Modafinil Small molecule 200 mg Oral
Comparator Modafinil Small molecule 300 mg Oral

Indications