Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00149630
Status:
COMPLETED
Last Update Posted:
2017-03-15
First Post:
2005-09-06
Brief Title:
Pharmacogenetics of Disulfiram for Cocaine
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Effectiveness of Disulfiram for Treating Cocaine Dependence in Individuals With Different Dopamine Beta Hydroxylase DBH Genes
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Disulfiram
Brief Summary:
Previous research has shown that disulfiram a medication sometimes used for treating alcoholism discourages cocaine use among cocaine addicts who are undergoing methadone treatment By blocking the enzyme dopamine beta hydroxylase DBH disulfiram increases levels of dopamine and produces an unpleasant sense of hyperstimulation and discomfort in cocaine users This study will evaluate the effectiveness of disulfiram in preventing drug relapse among cocaine and opiate addicts with varying inherited levels of DBH
Detailed Description:
Dopamine a type of neurotransmitter is the brains feel good chemical The amount of dopamine in the body may be an important factor in how cocaine addicts respond to treatment Disulfiram like cocaine enhances dopamine activity Upon taking disulfiram subsequent intake of cocaine may elevate dopamine to excessive levels that produce extreme discomfort DBH is an enzyme that breaks down dopamine A particular variation in the DBH gene can affect the amount of dopamine that is released in the body Therefore cocaine addicts with varying DBH genes may respond differently to treatment The purpose of this study is to compare the effectiveness of disulfiram in preventing relapse among methadone-maintained individuals addicted to both cocaine and opioids who may have different DBH genes
This 17-week study will begin with a 2-week methadone stabilization period Participants will then be randomly assigned to receive a daily dose of either 250 mg of disulfiram or placebo for 12 weeks while concurrently receiving methadone treatment All participants will stop receiving study medication at Week 14 at which point they will undergo a 4-week methadone detoxification period Participants will report cocaine and other drug use as well as any cocaine cravings that they experience Cocaine levels will be monitored throughout the study with urine tests The DBH gene of each participant will be examined to determine its specific make-up and any particular variations
This 17-week study will begin with a 2-week methadone stabilization period Participants will then be randomly assigned to receive a daily dose of either 250 mg of disulfiram or placebo for 12 weeks while concurrently receiving methadone treatment All participants will stop receiving study medication at Week 14 at which point they will undergo a 4-week methadone detoxification period Participants will report cocaine and other drug use as well as any cocaine cravings that they experience Cocaine levels will be monitored throughout the study with urine tests The DBH gene of each participant will be examined to determine its specific make-up and any particular variations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50DA018197-02 | NIH | None | httpsreporternihgovquickSearchP50DA018197-02 |