Modafinil for Smoked Cocaine Self-Administration

Study Overview
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Brief Summary
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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).

Official Title
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Modafinil in a Human Laboratory Model of Cocaine Relapse

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Drug: 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


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Modafinil 0mg + Cocaine 0, 12, 25, 50 mg<br>Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine. | Drug: Modafinil 0 mg<br>* Modafinil (0 mg/day)<br>Drug: Cocaine 0 mg<br>* Cocaine (0 mg/day)<br>Drug: Cocaine 12 mg<br>* Cocaine (12 mg/day)<br>Drug: Cocaine 25 mg<br>* Cocaine (25 mg/day)<br>Drug: Cocaine 50 mg<br>* Cocaine (50 mg/day)<br>|
| Experimental: Modafinil 200mg + Cocaine 0, 12, 25, 50 mg<br>Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine. | Drug: Modafinil 200 mg<br>* Modafinil (200 mg/day)<br>Drug: Cocaine 0 mg<br>* Cocaine (0 mg/day)<br>Drug: Cocaine 12 mg<br>* Cocaine (12 mg/day)<br>Drug: Cocaine 25 mg<br>* Cocaine (25 mg/day)<br>Drug: Cocaine 50 mg<br>* Cocaine (50 mg/day)<br>|
| Experimental: Modafinil 400mg + Cocaine 0, 12, 25, 50 mg<br>Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine. | Drug: Modafinil 400 mg<br>* Modafinil (400 mg/day)<br>Drug: Cocaine 0 mg<br>* Cocaine (0 mg/day)<br>Drug: Cocaine 12 mg<br>* Cocaine (12 mg/day)<br>Drug: Cocaine 25 mg<br>* Cocaine (25 mg/day)<br>Drug: Cocaine 50 mg<br>* Cocaine (50 mg/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine Self-administration | The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition. | 48 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Quality Cluster | Visual analogue scale ratings on the 'Drug Quality' cluster as a function of cocaine dose and modafinil maintenance condition. A cluster score was derived by taking the arithmetic average of the items in the cluster. Scores range from 0-100, with higher scores indicating greater agreement with the term. The Drug Quality Cluster consisted of three items: the choice was of high quality the choice was potent I liked the choice Higher scores indicate increasing agreement with the statement, which would indicate a poorer outcome. | 48 days | 
| Heart Rate | Values for heart rate as a function of cocaine dose and modafinil maintenance condition. | 48 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cocaine, modafinil, self-administration, DRD4