Cocaine-Related Disorders Clinical Trial
Official title:
Pharmacotherapy Dosing Regimen (Cocaine Dependence Population)
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.
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) 200 mg dose of modafinil; 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. Participants assigned to the 400 mg modafinil treatment group will
then receive double the initial dose of modafinil for the duration of the study.
Participants in the combined group (modafinil and d-amphetamine) will receive 15 and then 30
mg of d-amphetamine over 4 days.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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