NCT00218062

Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals

Pharmacotherapy Dosing Regimen (Cocaine Dependence Population)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effects of d-amphetamine and modafinil, when given alone and in combination, in treating cocaine dependent individuals.

Detailed description

Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Modafinil is a glutamate-enhancing agent. D-amphetamine is a central nervous system stimulant that is approved to treat individuals with narcolepsy and attention deficit disorder. Both modafinil and d-amphetamine may be effective treatments for cocaine dependence. The purpose of this study is to examine the effectiveness of modafinil and d-amphetamine, alone and in combination, in treating cocaine dependent individuals. This study will last 16 weeks. Participants will be randomly assigned to one of four groups: 1) 60 mg dose of d-amphetamine; 2) 400 mg dose of modafinil; 3) 30 mg dose of d-amphetamine combined with 200 mg dose of modafinil; and 4) placebo. All participants will receive 200 mg of modafinil over 4 days.

Conditions

• Cocaine-Related Disorders

Interventions

Type	Name	Description
DRUG	D-Amphetamine 30mg
DRUG	D-Amphetamine 60mg
DRUG	Modafinil 200mg
DRUG	Modafinil 400mg
BEHAVIORAL	Therapy	Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
DRUG	Placebo

Timeline

• Start date: 2006-03-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2005-09-22
• Last updated: 2017-06-21
• Results posted: 2017-06-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study