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Modafinil for Smoked Cocaine Self-Administration

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Modafinil 0 mg
Modafinil 200 mg
Modafinil 400 mg
Cocaine 0 mg
Cocaine 12 mg
Cocaine 25 mg
Cocaine 50 mg
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring cocaine, modafinil, self-administration, DRD4

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

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

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

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

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Cocaine Self-administration
The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition.

Secondary Outcome Measures

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.
Heart Rate
Values for heart rate as a function of cocaine dose and modafinil maintenance condition.

Full Information

First Posted
January 24, 2013
Last Updated
December 11, 2017
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01778010
Brief Title
Modafinil for Smoked Cocaine Self-Administration
Official Title
Modafinil in a Human Laboratory Model of Cocaine Relapse
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
cocaine, modafinil, self-administration, DRD4

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modafinil 0mg + Cocaine 0, 12, 25, 50 mg
Arm Type
Placebo Comparator
Arm Description
Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine.
Arm Title
Modafinil 200mg + Cocaine 0, 12, 25, 50 mg
Arm Type
Experimental
Arm Description
Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine.
Arm Title
Modafinil 400mg + Cocaine 0, 12, 25, 50 mg
Arm Type
Experimental
Arm Description
Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine.
Intervention Type
Drug
Intervention Name(s)
Modafinil 0 mg
Intervention Description
Modafinil (0 mg/day)
Intervention Type
Drug
Intervention Name(s)
Modafinil 200 mg
Intervention Description
Modafinil (200 mg/day)
Intervention Type
Drug
Intervention Name(s)
Modafinil 400 mg
Intervention Description
Modafinil (400 mg/day)
Intervention Type
Drug
Intervention Name(s)
Cocaine 0 mg
Intervention Description
Cocaine (0 mg/day)
Intervention Type
Drug
Intervention Name(s)
Cocaine 12 mg
Intervention Description
Cocaine (12 mg/day)
Intervention Type
Drug
Intervention Name(s)
Cocaine 25 mg
Intervention Description
Cocaine (25 mg/day)
Intervention Type
Drug
Intervention Name(s)
Cocaine 50 mg
Intervention Description
Cocaine (50 mg/day)
Primary Outcome Measure Information:
Title
Cocaine Self-administration
Description
The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition.
Time Frame
48 days
Secondary Outcome Measure Information:
Title
Drug Quality Cluster
Description
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.
Time Frame
48 days
Title
Heart Rate
Description
Values for heart rate as a function of cocaine dose and modafinil maintenance condition.
Time Frame
48 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Haney, Ph.D.
Organizational Affiliation
NYS Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Modafinil for Smoked Cocaine Self-Administration

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