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Modafinil for Smoked Cocaine Self-Administration

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ClinicalTrials.gov Identifier: NCT01778010
Recruitment Status : Completed
First Posted : January 29, 2013
Results First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Description
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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).

Condition or disease Intervention/treatment Phase
Cocaine Dependence 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 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Modafinil in a Human Laboratory Model of Cocaine Relapse
Study Start Date : March 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 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.
 Drug: Modafinil 0 mg
Modafinil (0 mg/day)

Drug: Cocaine 0 mg
Cocaine (0 mg/day)

Drug: Cocaine 12 mg
Cocaine (12 mg/day)

Drug: Cocaine 25 mg
Cocaine (25 mg/day)

Drug: Cocaine 50 mg
Cocaine (50 mg/day)
Experimental: 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.
 Drug: Modafinil 200 mg
Modafinil (200 mg/day)

Drug: Cocaine 0 mg
Cocaine (0 mg/day)

Drug: Cocaine 12 mg
Cocaine (12 mg/day)

Drug: Cocaine 25 mg
Cocaine (25 mg/day)

Drug: Cocaine 50 mg
Cocaine (50 mg/day)
Experimental: 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.
 Drug: Modafinil 400 mg
Modafinil (400 mg/day)

Drug: Cocaine 0 mg
Cocaine (0 mg/day)

Drug: Cocaine 12 mg
Cocaine (12 mg/day)

Drug: Cocaine 25 mg
Cocaine (25 mg/day)

Drug: Cocaine 50 mg
Cocaine (50 mg/day)


Outcome Measures
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Primary Outcome Measures :
  1. Cocaine Self-administration [ Time Frame: 48 days ]
    The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition.


Secondary Outcome Measures :
  1. Drug Quality Cluster [ Time Frame: 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.

  2. Heart Rate [ Time Frame: 48 days ]
    Values for heart rate as a function of cocaine dose and modafinil maintenance condition.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778010


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Margaret Haney, Ph.D. NYS Psychiatric Institute
More Information
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Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01778010    
Other Study ID Numbers: 5738
R01DA023650 ( U.S. NIH Grant/Contract )
First Posted: January 29, 2013    Key Record Dates
Results First Posted: January 9, 2018
Last Update Posted: January 9, 2018
Last Verified: December 2017
Keywords provided by New York State Psychiatric Institute:
cocaine
modafinil
self-administration
DRD4
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Neurotransmitter Agents