Modafinil for Smoked Cocaine Self-Administration

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Armodafinil; Cocaine; Modafinil

Criteria

Inclusion Criteria:

1. Smokes cocaine

2. Has patterns of smoked cocaine use in terms of frequency and amount which parallel or exceed those administered in the study.

3. Age 21-50.

4. Able to give informed consent, and comply with study procedures.

5. Normal body weight Within normal weight range (for appropriate frame) according to 1983 Metropolitan Weight tables -

Exclusion Criteria:

1. Current seizure disorder, heart disease or a history of serious adverse effects due to cocaine.

2. Dependence on substances (other than cocaine or nicotine) or a history of dependence on alcohol

3. Request for drug treatment

4. Judged to be noncompliant with study protocol.

5. Current use of any psychotropic medication.

6. 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)

7. History of myocardial infarction or ischemia, clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse

8. Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other than transient psychosis due to drug abuse

9. Current parole or probation Self-report during interview -