Clinical trial NCT00218062: Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals
Official title: Pharmacotherapy Dosing Regimen (Cocaine Dependence Population)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-09-22
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Meets Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-IV (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

Primary outcomes:
measure: Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment
timeFrame: 16 weeks
measure: Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment
timeFrame: 16 weeks
measure: Retention as Indicated by the Number of Participants Who Remained in the Study
timeFrame: 16 weeks
Secondary outcomes:
measure: Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report
timeFrame: 16 weeks
measure: Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas
name: Joy M. Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmitz JM, Rathnayaka N, Green CE, Moeller FG, Dougherty AE, Grabowski J. Combination of Modafinil and d-amphetamine for the Treatment of Cocaine Dependence: A Preliminary Investigation. Front Psychiatry. 2012 Aug 30;3:77. doi: 10.3389/fpsyt.2012.00077. eCollection 2012.