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

This study has suspended participant recruitment.
(Project moved to new university)
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00729300
First received: August 6, 2008
Last updated: April 7, 2009
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Cocaine Addiction
Drug: placebo
Drug: disulfiram
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Laboratory Models of Cocaine Self-Administration

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Efficacy [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: April 2006
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: placebo
placebo daily
Experimental: 2
disulfiram
Drug: disulfiram
250mg daily

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729300

Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77056
Sponsors and Collaborators
  More Information

No publications provided by National Institute on Drug Abuse (NIDA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Newton, Thomas F, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00729300     History of Changes
Other Study ID Numbers: 05-08-071-02A
Study First Received: August 6, 2008
Last Updated: April 7, 2009
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine
disulfiram
antabuse
addiction
stimulant

Additional relevant MeSH terms:
Behavior, Addictive
Cocaine-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Mental Disorders
Cocaine
Disulfiram
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Enzyme Inhibitors
Alcohol Deterrents

ClinicalTrials.gov processed this record on April 23, 2014