Modafinil for Smoked Cocaine Self-Administration

Cocaine Dependence Clinical Trial

Official title:

Modafinil in a Human Laboratory Model of Cocaine Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01778010
• Other study ID #: 5738
• Secondary ID: R01DA023650
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2013
• Last updated: December 11, 2017
• Start date: March 2009
• Est. completion date: June 2013

Study information

• Verified date: December 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Modafinil 0 mg
Modafinil (0 mg/day)
• Modafinil 200 mg
Modafinil (200 mg/day)
• Modafinil 400 mg
Modafinil (400 mg/day)
• Cocaine 0 mg
Cocaine (0 mg/day)
• Cocaine 12 mg
Cocaine (12 mg/day)
• Cocaine 25 mg
Cocaine (25 mg/day)
• Cocaine 50 mg
Cocaine (50 mg/day)

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cocaine Self-administration	The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition.	48 days
Secondary	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
Secondary	Heart Rate	Values for heart rate as a function of cocaine dose and modafinil maintenance condition.	48 days