Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-26 @ 2:01 PM
Study NCT ID:
NCT01143857
Status:
WITHDRAWN
Last Update Posted:
2013-10-16
First Post:
2010-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Behavioral Pharmacology Laboratory Study of Varenicline's Impact on Cocaine Reinforcement
Sponsor:
Jennifer Plebani
Organization:
Study Overview
Official Title:
Human Behavioral Pharmacology Laboratory Study of Varenicline's Impact on Cocaine Reinforcement
Status:
WITHDRAWN
Status Verified Date:
2013-10
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:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K01DA025073 | NIH | None | https://reporter.nih.gov/quic… | View |