Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218023
Status:
COMPLETED
Last Update Posted:
2017-06-09
First Post:
2005-09-16
Brief Title:
Medications for Stopping Cocaine Dependence and Preventing Relapse
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Screening Medications for Cocaine Cessation and Relapse Prevention
Status:
COMPLETED
Status Verified Date:
2017-05
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 dependence is a major public health problem an effective primary treatment for cocaine dependent individuals has yet to be found The purpose of this study is to identify subpopulations and baseline conditions that are most responsive to treatment for cocaine dependent individuals
Detailed Description:
Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates Due to its widespread use it is important to develop an effective treatment for cocaine dependence Motivational Interviewing MI is often effective when combined with drug treatment Baseline condition eg abstinence status and population type eg ethnicity and gender often affect how an individual responds to treatment for drug dependence The purpose of this study is to determine the influence of baseline status and population type on treatment response in cocaine dependent individuals In addition this study will examine how various cocaine abuse medications target different neuronal systems withdrawal symptoms and relapse to drug use
This study will take place in two phases Phase I will last 4 weeks participants will receive MI and undergo contingency-based urine tests in order to achieve the desired baseline condition Phase II will last 12 weeks Participants in Phase II will be randomly assigned to receive one of four treatments 1 50 mg naltrexone 2 800200 mg levodopacarbidopa 3 400 mg modafinil or 4 placebo During Phase II all participants will receive psychotherapy and contingency management Participants will complete urine drug screening tests 3 times each week Follow-up study visits will occur between 3 and 6 months following Week 12 and will include objective and self-reported drug use
This study will take place in two phases Phase I will last 4 weeks participants will receive MI and undergo contingency-based urine tests in order to achieve the desired baseline condition Phase II will last 12 weeks Participants in Phase II will be randomly assigned to receive one of four treatments 1 50 mg naltrexone 2 800200 mg levodopacarbidopa 3 400 mg modafinil or 4 placebo During Phase II all participants will receive psychotherapy and contingency management Participants will complete urine drug screening tests 3 times each week Follow-up study visits will occur between 3 and 6 months following Week 12 and will include objective and self-reported drug use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMC | OTHER | NIDA | httpsreporternihgovquickSearchP50DA009262-07 |
| P50DA009262-07 | NIH | None | None |