Cocaine Rapid Efficacy Screening Trials (CREST): lessons learned.

Abstract

AIMS:

The Cocaine Rapid Efficacy Screening Trials (CREST) were designed by the National Institute on Drug Abuse Division of Treatment Research and Development (NIDA, DT R&D) to rapidly screen a number of medications potentially useful for the treatment of cocaine dependence.

DESIGN:

Each CREST trial was designed to compare several medications in a single trial against an unmatched placebo. The placebo group was included in each trial to avoid the nearly universal positive response to medications seen in open-label trials. In addition, a common set of procedures and outcome measures were employed throughout to increase comparability of results obtained from different trials and from different times.

PARTICIPANTS:

In all, 18 medications were screened in seven different trials, conducted in four different sites throughout the United States involving 398 cocaine-dependent patients.

FINDINGS:

Three medications were found to be promising enough to include in subsequent larger trials. Common statistical procedures for evaluating medications were developed to facilitate comparisons across sites and across time. A portion of the data were pooled and analyzed, which yielded some useful insights into cocaine dependence and its treatment. Finally, a review of individual trials together with the pooled analysis revealed several potential improvements for future screening trials.

CONCLUSIONS:

Overall, the CREST trials proved to be useful for rapidly screening medications for treatment of cocaine dependence, but several modifications in design should be made before this framework is applied further.

• Authors: Kyle M Kampman, Deborah Leiderman, Tyson Holmes, Joseph LoCastro, Daniel A Bloch, Malcolm S Reid, Steve Shoptaw, Margaret A Montgomery, Theresa M Winhusen, Eugene C Somoza, Domenic A Ciraulo, Ahmed Elkashef, Frank Vocci
• Journal: Addiction (Abingdon, England) (Addiction) Vol. 100 Suppl 1 Pg. 102-10 (Mar 2005) ISSN: 0965-2140 [Print] England
• PMID: 15730354 (Publication Type: Journal Article, Meta-Analysis, Research Support, N.I.H., Extramural, Research Support, U.S. Gov't, P.H.S.)

Topics

• Clinical Trials as Topic
• Cocaine-Related Disorders (drug therapy)
• Female
• Humans
• Male
• Multicenter Studies as Topic
• Randomized Controlled Trials as Topic