NCT01143857

Human Behavioral Pharmacology Laboratory Study of Varenicline's Impact on Cocaine Reinforcement

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jennifer Plebani · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Cocaine use, abuse and dependence is a public health problem that is directly responsible for hundreds of billions of dollars in health care expenditures per year. Relapse rates to cocaine use are high, creating a pressing need to develop effective therapies for cocaine dependence. The proposed research will focus on investigating the determinants and consequences of cocaine dependence via measurement of physiological, behavioral and subjective effects of acute doses of cocaine in healthy non-drug dependent human volunteers in the laboratory, and through examination of the effects of pharmacotherapies on the above effects of cocaine. This study will examine cocaine-derived reinforcement under week-long sub-chronic varenicline (Chantix) dosing, and under placebo conditions. The study is a within-subjects crossover design using 24 subjects. Subjects will be screened and consented into the study at the Treatment Research Center (TRC). Study visits where behavioral and physiological outcome data will be obtained will be conducted at the Clinical and Translational Research Center (CTRC) of the Hospital of the University of Pennsylvania. Subjects will be outpatients for this trial, with CTRC sessions scheduled at least one week apart.

Conditions

• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Varenicline	Varenicline 2.0 mg/day or Placebo

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2010-06-14
• Last updated: 2013-10-16

Locations

1 site across 1 country: United States