Phase 2
N=73
Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals
Cocaine-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00218062 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment — 9.25; 6.09; 6; 4.91 number of cocaine negative urines
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- D-Amphetamine 30mg (Drug); D-Amphetamine 60mg (Drug); Modafinil 200mg (Drug); Modafinil 400mg (Drug); Therapy (Behavioral); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment |
9.25; 6.09; 6; 4.91 | — |
| PRIMARY Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment |
7; 4; 3; 3 | — |
| PRIMARY Retention as Indicated by the Number of Participants Who Remained in the Study |
7; 4; 3; 3 | — |
| SECONDARY Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report |
80.2; 34.5; 65.8; 73.2 | — |
| SECONDARY Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples |
67.1; 70; 76.8; 66.7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00218062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.