Modafinil for Smoked Cocaine Self-Administration

NCT ID: NCT01778010

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2013-06-30

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).

Conditions

Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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

Group Type: PLACEBO_COMPARATOR

Modafinil 0 mg

Intervention Type: DRUG

Modafinil (0 mg/day)

Cocaine 0 mg

Intervention Type: DRUG

Cocaine (0 mg/day)

Cocaine 12 mg

Intervention Type: DRUG

Cocaine (12 mg/day)

Cocaine 25 mg

Intervention Type: DRUG

Cocaine (25 mg/day)

Cocaine 50 mg

Intervention Type: DRUG

Cocaine (50 mg/day)

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

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

Group Type: EXPERIMENTAL

Modafinil 200 mg

Intervention Type: DRUG

Modafinil (200 mg/day)

Cocaine 0 mg

Intervention Type: DRUG

Cocaine (0 mg/day)

Cocaine 12 mg

Intervention Type: DRUG

Cocaine (12 mg/day)

Cocaine 25 mg

Intervention Type: DRUG

Cocaine (25 mg/day)

Cocaine 50 mg

Intervention Type: DRUG

Cocaine (50 mg/day)

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

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

Group Type: EXPERIMENTAL

Modafinil 400 mg

Intervention Type: DRUG

Modafinil (400 mg/day)

Cocaine 0 mg

Intervention Type: DRUG

Cocaine (0 mg/day)

Cocaine 12 mg

Intervention Type: DRUG

Cocaine (12 mg/day)

Cocaine 25 mg

Intervention Type: DRUG

Cocaine (25 mg/day)

Cocaine 50 mg

Intervention Type: DRUG

Cocaine (50 mg/day)

Interventions

Modafinil 0 mg

Modafinil (0 mg/day)

Intervention Type: DRUG

Modafinil 200 mg

Modafinil (200 mg/day)

Intervention Type: DRUG

Modafinil 400 mg

Modafinil (400 mg/day)

Intervention Type: DRUG

Cocaine 0 mg

Cocaine (0 mg/day)

Intervention Type: DRUG

Cocaine 12 mg

Cocaine (12 mg/day)

Intervention Type: DRUG

Cocaine 25 mg

Cocaine (25 mg/day)

Intervention Type: DRUG

Cocaine 50 mg

Cocaine (50 mg/day)

Intervention Type: DRUG

Eligibility 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 -

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret Haney, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

NYS Psychiatric Institute

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

R01DA023650

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5738

Identifier Type: -

Identifier Source: org_study_id