Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218608
Status:
COMPLETED
Last Update Posted:
2012-01-31
First Post:
2005-09-20
Brief Title:
Disulfiram for Treating Cocaine Dependence in Individuals Maintained on Methadone
Sponsor:
University of Arkansas
Organization:
University of Arkansas
Study Overview
Official Title:
Disulfiram for Cocaine Abuse in Methadone- Patients
Status:
COMPLETED
Status Verified Date:
2012-01
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:
None
Brief Summary:
Cocaine is an extremely addictive stimulant drug that directly affects the brain It is used in several different forms and can be snorted smoked or injected to achieve the desired effect Cocaine users are at risk for many health problems both directly and indirectly related to the effects of cocaine Disulfiram a drug used to treat chronic alcoholism may be effective in reducing cocaine use This study will evaluate the effectiveness of three different doses of disulfiram in treating cocaine dependence in opioid- and cocaine-dependent individuals maintained on methadone
Detailed Description:
Despite the harm that cocaine can cause to the body its abuse is widespread It is the cause of more visits to hospital emergency rooms nationwide than any other illegal drug Effective treatments for cocaine and opiate addictions are essential to the decline of cocaine- and opiate-related disorders Unfortunately cocaine use remains prevalent among participants in many opioid maintenance programs The addition of other medications to methadone maintenance may prove helpful in reducing cocaine use Disulfiram a drug used to treat chronic alcoholism causes unpleasant effects when even small amounts of alcohol are consumed This study will evaluate the effectiveness of three different doses of disulfiram in treating cocaine dependence in opioid- and cocaine-dependent individuals maintained on methadone
Participants in this double blind study will be randomly assigned to receive either disulfiram at one of three dosage levels 625 125 250 mgday or placebo for 14 weeks During the first 2 weeks doses of methadone plus either disulfiram or placebo will be administered until the assigned maintenance dose is achieved This dosage level will be maintained for the duration of the study Participants will be required to report to the study site Monday through Saturday of each week for assessments and to receive medication They will receive a take-home dose of medication for Sunday In addition participants will receive a weekly session of cognitive-behavioral therapy Urine samples will be collected three times a week to assess drug use At the end of the study participants will undergo a 4- to 6-week detoxification period in which they will gradually discontinue the use of methadone and disulfiram All participants have the option to request transfer to a local methadone maintenance program instead of undergoing detoxification
Enrollment has been completed and no subjects are active Data analyses are being conducted at this time
Participants in this double blind study will be randomly assigned to receive either disulfiram at one of three dosage levels 625 125 250 mgday or placebo for 14 weeks During the first 2 weeks doses of methadone plus either disulfiram or placebo will be administered until the assigned maintenance dose is achieved This dosage level will be maintained for the duration of the study Participants will be required to report to the study site Monday through Saturday of each week for assessments and to receive medication They will receive a take-home dose of medication for Sunday In addition participants will receive a weekly session of cognitive-behavioral therapy Urine samples will be collected three times a week to assess drug use At the end of the study participants will undergo a 4- to 6-week detoxification period in which they will gradually discontinue the use of methadone and disulfiram All participants have the option to request transfer to a local methadone maintenance program instead of undergoing detoxification
Enrollment has been completed and no subjects are active Data analyses are being conducted at this time
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 |
|---|---|---|---|
| DPMC | None | None | None |
| R01-13441-1 | None | None | None |