NCT01778010

Modafinil for Smoked Cocaine Self-Administration

Modafinil in a Human Laboratory Model of Cocaine Relapse

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2 days/week), but the effects of modafinil on cocaine self-administration in the laboratory have not been studied. The present study investigated the effects of modafinil maintenance on cocaine self-administration by frequent users (4 days/week) under controlled laboratory conditions. During this 48-day double-blind, crossover design study, the effects of modafinil maintenance (0, 200, and 400mg/day) on response to smoked cocaine (0, 12, 25, and 50 mg) were examined in nontreatment seeking cocaine-dependent individuals (n = 8).

Conditions

• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Modafinil 0 mg	Modafinil (0 mg/day)
DRUG	Modafinil 200 mg	Modafinil (200 mg/day)
DRUG	Modafinil 400 mg	Modafinil (400 mg/day)
DRUG	Cocaine 0 mg	Cocaine (0 mg/day)
DRUG	Cocaine 12 mg	Cocaine (12 mg/day)
DRUG	Cocaine 25 mg	Cocaine (25 mg/day)
DRUG	Cocaine 50 mg	Cocaine (50 mg/day)

Timeline

• Start date: 2009-03-01
• Primary completion: 2013-03-01
• Completion: 2013-06-01
• First posted: 2013-01-29
• Last updated: 2018-01-09
• Results posted: 2018-01-09

Locations

1 site across 1 country: United States