Modafinil for Smoked Cocaine Self-Administration



Status:Completed
Conditions:Psychiatric, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:21 - 50
Updated:1/11/2018
Start Date:March 2009
End Date:June 2013

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Modafinil in a Human Laboratory Model of Cocaine Relapse

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).


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 -
We found this trial at
1
site
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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from
New York, NY
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