Stress and Medication Effects on Cocaine Cue Reactivity
Stressful situations and cues associated with cocaine can lead to craving in cocaine dependent individuals. The purpose of this study is to determine whether guanfacine or modafinil are effective in reducing stress and cue induced craving in cocaine dependent individuals.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Interdisciplinary Medication Development for Multiple Risk Factors in Relapse.|
- The primary outcome will be assessing the internal validity the TSST and also a cocaine cue reactivity paradigm, utilizing physiological, endocrine, and self reported measurements of mood, craving, and anxiety data. [ Time Frame: one hour ] [ Designated as safety issue: No ]
- Secondary outcome measures will assess how pretreatment with either modafinil or guanfacine influences stress and cocaine cue induced craving, utilizing physiological, endocrine, and self reported measurements of mood, craving, and anxiety data. [ Time Frame: one week ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||May 2008|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Stress and cocaine cues produce craving and ultimately relapse in cocaine dependent individuals. This is a randomized, double-blind, placebo-controlled study evaluating the effects of either guanfacine (Tenex) or modafinil (Provigil) on stress and cue induced craving in cocaine dependent individuals. Cocaine dependence will be assessed in adults (ages 18-65) as defined by DSM-IV criteria. If the subject signs the consent form, meets the study criteria and does not meet the exclusion criteria they will be included in the study. Subjects will report to the General Clinical Research Center (GCRC) at the Medical University of South Carolina (MUSC), for an outpatient visit and will receive their first dose of study medication. The following day subjects will return to the GCRC and admitted for the duration of the study (two days and one night). There will be a one-week and a one-month follow-up visit. Subjects will be randomly assigned to one of two treatment groups (guanfacine or placebo). Each subject will also be randomly assigned to either a stress or no-stress subgroup. On the test day (day 3) subjects in the stress group will be asked to perform a speech and a math problem in front of an audience (Trier Social Stress Test, TSST), while the no-stress group will be asked to sit quietly and read. Following these tasks, each subject will be exposed to neutral (control) cues and immediately afterwards the subjects will be exposed to cocaine cues (cocaine paraphernalia). Craving/mood, physiological activity, and endocrine responses, will be assessed at pre-set intervals throughout the testing procedure. The cue reactivity protocol will be repeated on the one-week follow-up visit.
|United States, South Carolina|
|Medical University of South Carolina-GCRC|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Ronald E See, Ph.D.||Medical University of South Carolina|