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A Study of the Relationship Between Disulfiram and Cocaine Self-administration.

Primary Purpose

Cocaine Addiction

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
placebo
disulfiram
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cocaine Addiction focused on measuring cocaine, disulfiram, antabuse, addiction, stimulant

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Meet DSM IV criteria for cocaine dependence; 2. Have a self-reported history of using cocaine by the smoked or IV route. Participants must report at least weekly use for the past month and have a cocaine-positive urine test in the week of study entry; 3. Have vital signs after a 48 hours washout period as follows: resting pulse between 50 and 80 bpm, blood pressures between 105-130mm Hg systolic and 45-80mm Hg diastolic; 4. Have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions: a) liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) < 3 x the upper limit of normal, and b) kidney function tests (creatinine and BUN) < 2 x the upper limit of normal; 5. Have a baseline ECG that demonstrates normal sinus rhythm, normal conduction, and no clinically significant arrhythmias; and 6. Have a medical history and standard physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator.

Exclusion Criteria:

  • 1. Have any history or evidence suggestive of seizures or brain injury 2. Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, or epileptic seizure; 3. Have neurological or psychiatric disorders, such as:

    • psychosis, bipolar illness or major depression as assessed by MINI (or SCID if necessary);
    • organic brain disease or dementia assessed by clinical interview;
    • history of any psychiatric disorder which would require ongoing treatment or which would make study compliance difficult;
    • history of suicide attempts within the past three months assessed by MINI and/or current suicidal ideation/plan as assessed by MINI; 4. Have evidence of clinically significant heart disease or hypertension, as determined by the PI; 5. Have a family history in first degree relatives of early cardiovascular morbidity or mortality, as determined by the PI; 6. Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease; 7. Have HIV and are currently symptomatic, have a diagnosis of AIDS, or are receiving antiretroviral medication; 8. Have any history of asthma, chronic coughing and wheezing, or other respiratory illnesses; 9. Heavy current alcohol intake that is likely to lead to withdrawal symptoms, in the opinion of the PI; 10. Refuse to abstain from alcohol during the protocol and for at least one week after discharge.

      11. Have any other illness, condition, or use of medications, which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study.

Sites / Locations

  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Placebo

disulfiram

Outcomes

Primary Outcome Measures

Cocaine Self-administration
The reinforcing effects of cocaine were determined using a self-administration procedure in which subjects choose to take previously sampled doses of cocaine or cash of increasing monetary value. The mean number of cocaine choices across each drug condition (i.e., placebo and disulfiram) is reported.

Secondary Outcome Measures

Full Information

First Posted
August 6, 2008
Last Updated
June 27, 2023
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00729300
Brief Title
A Study of the Relationship Between Disulfiram and Cocaine Self-administration.
Official Title
Laboratory Models of Cocaine Self-administration
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The problem of cocaine dependence remains a major medical, social, and legal concern. Several studies have suggested that disulfiram may be beneficial for the treatment of cocaine dependence. A common assumption has been that disulfiram treatment, by increasing DA availability, enhances the aversive aspects of stimulants. This study aims to measure plasma activity in those with the C/C DBH genotype, which is associated with higher DBH activity subsequently making the disulfiram treatment more effective, as well as determine the effects of treatment with disulfiram on cocaine self-administration using a human laboratory model of cocaine self-administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Addiction
Keywords
cocaine, disulfiram, antabuse, addiction, stimulant

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
disulfiram
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
0mg daily
Intervention Type
Drug
Intervention Name(s)
disulfiram
Intervention Description
250mg daily
Primary Outcome Measure Information:
Title
Cocaine Self-administration
Description
The reinforcing effects of cocaine were determined using a self-administration procedure in which subjects choose to take previously sampled doses of cocaine or cash of increasing monetary value. The mean number of cocaine choices across each drug condition (i.e., placebo and disulfiram) is reported.
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Meet DSM IV criteria for cocaine dependence; 2. Have a self-reported history of using cocaine by the smoked or IV route. Participants must report at least weekly use for the past month and have a cocaine-positive urine test in the week of study entry; 3. Have vital signs after a 48 hours washout period as follows: resting pulse between 50 and 80 bpm, blood pressures between 105-130mm Hg systolic and 45-80mm Hg diastolic; 4. Have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions: a) liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) < 3 x the upper limit of normal, and b) kidney function tests (creatinine and BUN) < 2 x the upper limit of normal; 5. Have a baseline ECG that demonstrates normal sinus rhythm, normal conduction, and no clinically significant arrhythmias; and 6. Have a medical history and standard physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator. Exclusion Criteria: 1. Have any history or evidence suggestive of seizures or brain injury 2. Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, or epileptic seizure; 3. Have neurological or psychiatric disorders, such as: psychosis, bipolar illness or major depression as assessed by MINI (or SCID if necessary); organic brain disease or dementia assessed by clinical interview; history of any psychiatric disorder which would require ongoing treatment or which would make study compliance difficult; history of suicide attempts within the past three months assessed by MINI and/or current suicidal ideation/plan as assessed by MINI; 4. Have evidence of clinically significant heart disease or hypertension, as determined by the PI; 5. Have a family history in first degree relatives of early cardiovascular morbidity or mortality, as determined by the PI; 6. Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease; 7. Have HIV and are currently symptomatic, have a diagnosis of AIDS, or are receiving antiretroviral medication; 8. Have any history of asthma, chronic coughing and wheezing, or other respiratory illnesses; 9. Heavy current alcohol intake that is likely to lead to withdrawal symptoms, in the opinion of the PI; 10. Refuse to abstain from alcohol during the protocol and for at least one week after discharge. 11. Have any other illness, condition, or use of medications, which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Newton, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23144826
Citation
Haile CN, De La Garza R 2nd, Mahoney JJ 3rd, Nielsen DA, Kosten TR, Newton TF. The impact of disulfiram treatment on the reinforcing effects of cocaine: a randomized clinical trial. PLoS One. 2012;7(11):e47702. doi: 10.1371/journal.pone.0047702. Epub 2012 Nov 8.
Results Reference
derived

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A Study of the Relationship Between Disulfiram and Cocaine Self-administration.

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