Phase 2
N=13
Modafinil for Smoked Cocaine Self-Administration
Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01778010 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Cocaine Self-administration — 0; 0; 0; 2.2 Number of doses purchased
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Modafinil 0 mg (Drug); Modafinil 200 mg (Drug); Modafinil 400 mg (Drug); Cocaine 0 mg (Drug); Cocaine 12 mg (Drug); Cocaine 25 mg (Drug); Cocaine 50 mg (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cocaine Self-administration |
0; 0; 0; 2.2; 1.5; 2.1 | — |
| SECONDARY Drug Quality Cluster |
2; 2; 2; 30; 28; 29 | — |
| SECONDARY Heart Rate |
88; 86; 91; 102; 101; 97 | — |
Summary
Modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2 days/week), but the effects of modafinil on cocaine self-administration in the laboratory have not been studied. The present study investigated the effects of modafinil maintenance on cocaine self-administration by frequent users (4 days/week) under controlled laboratory conditions. During this 48-day double-blind, crossover design study, the effects of modafinil maintenance (0, 200, and 400mg/day) on response to smoked cocaine (0, 12, 25, and 50 mg) were examined in nontreatment seeking cocaine-dependent individuals (n = 8).
Eligibility Criteria
Inclusion Criteria
- Smokes cocaine
- Has patterns of smoked cocaine use in terms of frequency and amount which parallel or exceed those administered in the study.
- Age 21-50.
- Able to give informed consent, and comply with study procedures.
- Normal body weight Within normal weight range (for appropriate frame) according to 1983 Metropolitan Weight tables -
Exclusion Criteria
- Current seizure disorder, heart disease or a history of serious adverse effects due to cocaine.
- Dependence on substances (other than cocaine or nicotine) or a history of dependence on alcohol
- Request for drug treatment
- Judged to be noncompliant with study protocol.
- Current use of any psychotropic medication.
- Clinical laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP > 140/90; BUN, creatinine, LFTs > 3x ULN; hematocrit < 34 for women, < 36 for men; pseudocholinesterase deficiency)
- History of myocardial infarction or ischemia, clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse
- Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other than transient psychosis due to drug abuse
- Current parole or probation Self-report during interview -
Data sourced from ClinicalTrials.gov (NCT01778010). 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.