Modafinil for Smoked Cocaine Self-Administration

Phase 2

Completed

Conditions: Cocaine Dependence

Interventions: Drug: Modafinil 200 mg
Drug: Modafinil 400 mg
Drug: Modafinil 0 mg
Drug: Cocaine 0 mg
Drug: Cocaine 12 mg
Drug: Cocaine 25 mg
Drug: Cocaine 50 mg

Registration Number: NCT01778010

Lead Sponsor: New York State Psychiatric Institute

Brief 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8

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 -

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Modafinil 0mg + Cocaine 0, 12, 25, 50 mg	Cocaine 12 mg	Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine.
Modafinil 400mg + Cocaine 0, 12, 25, 50 mg	Cocaine 0 mg	Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine.
Modafinil 200mg + Cocaine 0, 12, 25, 50 mg	Cocaine 12 mg	Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine.
Modafinil 0mg + Cocaine 0, 12, 25, 50 mg	Cocaine 25 mg	Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine.
Modafinil 0mg + Cocaine 0, 12, 25, 50 mg	Cocaine 50 mg	Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine.
Modafinil 200mg + Cocaine 0, 12, 25, 50 mg	Cocaine 25 mg	Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine.
Modafinil 400mg + Cocaine 0, 12, 25, 50 mg	Cocaine 50 mg	Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine.
Modafinil 200mg + Cocaine 0, 12, 25, 50 mg	Modafinil 200 mg	Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine.
Modafinil 200mg + Cocaine 0, 12, 25, 50 mg	Cocaine 50 mg	Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine.
Modafinil 400mg + Cocaine 0, 12, 25, 50 mg	Cocaine 12 mg	Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine.
Modafinil 400mg + Cocaine 0, 12, 25, 50 mg	Cocaine 25 mg	Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine.
Modafinil 200mg + Cocaine 0, 12, 25, 50 mg	Cocaine 0 mg	Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine.
Modafinil 400mg + Cocaine 0, 12, 25, 50 mg	Modafinil 400 mg	Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine.
Modafinil 0mg + Cocaine 0, 12, 25, 50 mg	Modafinil 0 mg	Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine.
Modafinil 0mg + Cocaine 0, 12, 25, 50 mg	Cocaine 0 mg	Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine.

Primary Outcome Measures

Name	Time	Method
Cocaine Self-administration	48 days	The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition.

Secondary Outcome Measures

Name	Time	Method
Heart Rate	48 days	Values for heart rate as a function of cocaine dose and modafinil maintenance condition.
Drug Quality Cluster	48 days	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: 1. "the choice was of high quality" 2. "the choice was potent" 3. "I liked the choice" Higher scores indicate increasing agreement with the statement, which would indicate a poorer outcome.