Modafinil for Smoked Cocaine Self-Administration

New York State Psychiatric Institute

Status and phase: Completed; Phase 2

Conditions: Cocaine Dependence

Treatments: Drug: Cocaine 25 mg; Drug: Cocaine 12 mg; Drug: Modafinil 200 mg; Drug: Modafinil 400 mg; Drug: Modafinil 0 mg; Drug: Cocaine 0 mg; Drug: Cocaine 50 mg

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01778010

5738

R01DA023650 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 8 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

8 participants in 3 patient groups, including a placebo group

Modafinil 0mg + Cocaine 0, 12, 25, 50 mg

Placebo Comparator group

Description:

Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine.

Treatment:

Drug: Cocaine 50 mg

Drug: Cocaine 0 mg

Drug: Modafinil 0 mg

Drug: Cocaine 12 mg

Drug: Cocaine 25 mg

Modafinil 200mg + Cocaine 0, 12, 25, 50 mg

Experimental group

Description:

Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine.

Treatment:

Drug: Cocaine 50 mg

Drug: Cocaine 0 mg

Drug: Modafinil 200 mg

Drug: Cocaine 12 mg

Drug: Cocaine 25 mg

Modafinil 400mg + Cocaine 0, 12, 25, 50 mg

Experimental group

Description:

Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine.

Treatment:

Drug: Cocaine 50 mg

Drug: Cocaine 0 mg

Drug: Modafinil 400 mg

Drug: Cocaine 12 mg

Drug: Cocaine 25 mg