Modafinil for Smoked Cocaine Self-Administration

NCT01778010 | Completed Phase 2 Results

• 2 other identifiers: 5738R01DA023650
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

cocaine; modafinil; self-administration; DRD4

Outcome Measures

Primary Outcomes (1)

• Cocaine Self-administration

  The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition.

  48 days

Secondary Outcomes (2)

• Drug Quality Cluster

  48 days

• Heart Rate

  48 days

Study Arms (3)

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

PLACEBO COMPARATOR

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

Drug: Modafinil 0 mg; Drug: Cocaine 0 mg; Drug: Cocaine 12 mg; Drug: Cocaine 25 mg; Drug: Cocaine 50 mg

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

EXPERIMENTAL

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

Drug: Modafinil 200 mg; Drug: Cocaine 0 mg; Drug: Cocaine 12 mg; Drug: Cocaine 25 mg; Drug: Cocaine 50 mg

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

EXPERIMENTAL

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

Drug: Modafinil 400 mg; Drug: Cocaine 0 mg; Drug: Cocaine 12 mg; Drug: Cocaine 25 mg; Drug: Cocaine 50 mg

Interventions

Modafinil 0 mg DRUG

Modafinil (0 mg/day)

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

Modafinil 200 mg DRUG

Modafinil (200 mg/day)

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

Modafinil 400 mg DRUG

Modafinil (400 mg/day)

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

Cocaine 0 mg DRUG

Cocaine (0 mg/day)

Modafinil 0mg + Cocaine 0, 12, 25, 50 mg; Modafinil 200mg + Cocaine 0, 12, 25, 50 mg; Modafinil 400mg + Cocaine 0, 12, 25, 50 mg

Cocaine 12 mg DRUG

Cocaine (12 mg/day)

Modafinil 0mg + Cocaine 0, 12, 25, 50 mg; Modafinil 200mg + Cocaine 0, 12, 25, 50 mg; Modafinil 400mg + Cocaine 0, 12, 25, 50 mg

Cocaine 25 mg DRUG

Cocaine (25 mg/day)

Modafinil 0mg + Cocaine 0, 12, 25, 50 mg; Modafinil 200mg + Cocaine 0, 12, 25, 50 mg; Modafinil 400mg + Cocaine 0, 12, 25, 50 mg

Cocaine 50 mg DRUG

Cocaine (50 mg/day)

Modafinil 0mg + Cocaine 0, 12, 25, 50 mg; Modafinil 200mg + Cocaine 0, 12, 25, 50 mg; Modafinil 400mg + Cocaine 0, 12, 25, 50 mg

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 -

You may not qualify if:

• 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 -

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Modafinil; Cocaine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Limitations and Caveats

This study is limited by the small, non-diverse sample.

Results Point of Contact

• Title: Margaret Haney, Ph.D.
• Organization: New York State Psychiatric Institute at Columbia University Medical Center

meg.haney@nyspi.columbia.edu

646-774-6153

Study Officials

• Margaret Haney, Ph.D.

  NYS Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 29, 2013
• Study Start: March 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 9, 2018
• Results First Posted: January 9, 2018

Record last verified: 2017-12

Locations

US (1)