Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015106
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2001-04-18
Brief Title:
Resperine Gabapentin or Lamotrigine for the Treatment of Cocaine Dependence 2 - 7
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
CREST-I Resperine Gabapentin or Lamotrigine vs Placebo
Status:
COMPLETED
Status Verified Date:
1999-02
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:
None
Brief Summary:
The purpose of this CREST Clinical Rapid Evaluation Screening Trial study is the treatment of cocaine dependence using reserpine gabapentin or lamotrigine vs an unmatched placebo control
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 60-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 reserpine gabapentin and lamotrigine Reserpine is being screened because of its well-known preclinical ability to functionally antagonize cocaine by depleting neurochemicals elevated by cocaine Gabapentin and lamotrigine are hypothesized to interfere with glutamatergic cocaine sensitizationkindling 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 60-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 reserpine gabapentin and lamotrigine Reserpine is being screened because of its well-known preclinical ability to functionally antagonize cocaine by depleting neurochemicals elevated by cocaine Gabapentin and lamotrigine are hypothesized to interfere with glutamatergic cocaine sensitizationkindling 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 |
|---|---|---|---|
| Y01-5-0012-7 | None | None | None |