Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015132
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2001-04-18
Brief Title:
Tiagabine Sertraline or Donepezil for the Treatment of Cocaine Dependence - 9
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
CREST-II Tiagabine Sertraline or Donepezil vs Unmatched Placebo
Status:
COMPLETED
Status Verified Date:
1999-03
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:
The purpose of this CREST Clinical Rapid Evaluation Screening Trial study is the use of tiagabine sertraline or donepezil for the treatment of cocaine dependence using a modified placebo-controlled experimental design
Detailed Description:
Considerable progress in preclinical research has provided a basis for hypothesis driven clinical trials in cocaine dependence A greater mechanistic understanding of both cocaine and many clinically approved medications has led to the identification of many promising medications for the treatment of cocaine dependence
For this reason NIDA has developed a CREST Clinical Rapid Evaluation Screening Trial protocol to provide a needed incremental medication screening step between preclinical research and full blown expensive Phase III pivotal trials While patients receive manual based psychotherapy three medications are screened compared to unmatched placebo in an eight-week 80-subject four cell design trial Other important features of the CREST protocol include collecting baseline measurements over a two week period and analyzing primary outcome measures quantitative urine toxicology and clinical global improvement scales in terms of a composite score of overall individual patient improvement
The three medications being evaluated in this trial include tiagabine sertraline and donepzil Tiagabine is hypothesized to interfere with glutamatergic cocaine mechanisms relevant to addiction Sertraline is a potent and selective inhibitor of neuronal 5-HT reuptake which may modulate the reinforcing and cueing effects of cocaine Donepezil is hypothesized to interfere with cholinergic cocaine mechanisms relevant to addiction
For this reason NIDA has developed a CREST Clinical Rapid Evaluation Screening Trial protocol to provide a needed incremental medication screening step between preclinical research and full blown expensive Phase III pivotal trials While patients receive manual based psychotherapy three medications are screened compared to unmatched placebo in an eight-week 80-subject four cell design trial Other important features of the CREST protocol include collecting baseline measurements over a two week period and analyzing primary outcome measures quantitative urine toxicology and clinical global improvement scales in terms of a composite score of overall individual patient improvement
The three medications being evaluated in this trial include tiagabine sertraline and donepzil Tiagabine is hypothesized to interfere with glutamatergic cocaine mechanisms relevant to addiction Sertraline is a potent and selective inhibitor of neuronal 5-HT reuptake which may modulate the reinforcing and cueing effects of cocaine Donepezil is hypothesized to interfere with cholinergic cocaine mechanisms relevant to addiction
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Y01-5-0012-9 | None | None | None |