Clinical Trial: Stress and Medication Effects on Cocaine Cue Reactivity

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Interdisciplinary Medication Development for Multiple Risk Factors in Relapse.

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Medical University of South Carolina

Current Primary Outcome: Cocaine Craving- 2:30 pm, Immediately Following Trier + Cocaine Cue Exposure [ Time Frame: Post Trier social stress task + Cocaine Cue ]

Participants were randomized to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to participate in the TRIER social stress task or to read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for 2 minutes and cocaine cues for 2 minutes. Immediately following the cocaine cue exposure, participants were asked to rate cocaine craving on a 10-point Likert scale, with 0 being Not at All and 10 being Extremely.


Original Primary Outcome: 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 ]

Current Secondary Outcome: Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure [ Time Frame: Immediately following trier + cocaine cue exposure ]

Participants were randomized to receive to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to complete a TRIER social stress task or read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for two minutes and control cues for two minutes. Immediately following exposure to the cocaine cue, saliva samples were collected to measure cortisol levels.


Original Secondary Outcome: 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 ]

Information By: Medical University of South Carolina

Dates:
Date Received: February 8, 2008
Date Started: May 2008
Date Completion:
Last Updated: February 8, 2016
Last Verified: February 2016