Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129298
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-08-04
Brief Title:
Effectiveness of Tiagabine for Cocaine Dependence in Methadone-Maintained Individuals - 1
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Tiagabine for the Treatment of Cocaine Dependence in Methadone-Maintained Individuals
Status:
COMPLETED
Status Verified Date:
2007-12
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:
Many opioid-dependent individuals are also dependent on cocaine Methadone is a widely used and effective method for treating opioid dependence However it is not effective in treating other drugs of abuse The purpose of this study is to determine the effectiveness of another drug tiagabine for treating cocaine dependence in opioid-dependent individuals already receiving methadone treatment
Detailed Description:
For over 30 years methadone has been used to treat opioid addiction Since methadone is effective in reducing withdrawal symptoms it is used as a method of detoxification for opiate addicts However methadone is not effective in treating other drugs of abuse such as cocaine Tiagabine is a drug that enhances levels of gamma aminobutyric acid GABA a chemical found in the brain and spinal cord The objective of this study is to determine the effectiveness of tiagabine in modifying cocaine-using behavior and reducing opiate withdrawal symptoms among newly admitted methadone-treated patients
This 16-week double-blind placebo-controlled clinical trial will involve 120 participants who are both cocaine- and opioid- dependent Participants will be randomly assigned to receive either tiagabine or placebo while concurrently receiving methadone treatment Baseline cocaine use will be determined during the first two weeks of treatment The study will include three overlapping phases The first phase will include a one-week fixed methadone induction Week 1 as well as flexible methadone stabilization Weeks 2-13 Phase two will consist of a 12-week treatment period Weeks 2-13 This will consist of tiagabine induction and stabilization Phase three will include a 4-week taper detoxification or transfer period Weeks 14-17 After completion of treatment a 3-month follow-up visit will occur
This 16-week double-blind placebo-controlled clinical trial will involve 120 participants who are both cocaine- and opioid- dependent Participants will be randomly assigned to receive either tiagabine or placebo while concurrently receiving methadone treatment Baseline cocaine use will be determined during the first two weeks of treatment The study will include three overlapping phases The first phase will include a one-week fixed methadone induction Week 1 as well as flexible methadone stabilization Weeks 2-13 Phase two will consist of a 12-week treatment period Weeks 2-13 This will consist of tiagabine induction and stabilization Phase three will include a 4-week taper detoxification or transfer period Weeks 14-17 After completion of treatment a 3-month follow-up visit will occur
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 |
| R01-17782-1 | None | None | None |