Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals
Information source: The University of Texas Health Science Center, Houston
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine-Related Disorders
Intervention: Dextro amphetamine sulfate and Modafinil (Drug); modafinil (Drug); Modafinil 400 mg (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: The University of Texas Health Science Center, Houston Official(s) and/or principal investigator(s): Joy M. Schmitz, PhD, Principal Investigator, Affiliation: University of Texas
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.
Clinical Details
Official title: Pharmacotherapy Dosing Regimen (Cocaine Dependence Population)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Substance use
Secondary outcome: Medication compliancemedication side effects
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) 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Meets SCID criteria for cocaine abuse or dependence
- In general good health. Individuals who are HIV-positive will not be excluded if in
good general health, unless medication interactions exist.
Exclusion Criteria:
- Meets diagnostic criteria for psychiatric disorders, including other forms of drug
dependence, other than nicotine
- Current cardiovascular disease, as determined by an electrocardiogram
- On probation or parole if the circumstances do not allow study completion or if
ethical constraints of supervision do not allow confidentiality
- Previously received treatment with d-amphetamine, modafinil, or aripiprazole
- Currently receiving prescribed medication
Locations and Contacts
University of Texas Health Science Center, Houston, Texas 77030, United States
Additional Information
Starting date: March 2006
Last updated: March 2, 2012
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