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Clinical Trials/NCT01143857
NCT01143857
Withdrawn
Phase 2

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

Jennifer Plebani1 site in 1 countryJune 2010
InterventionsVarenicline

Overview

Phase
Phase 2
Intervention
Varenicline
Conditions
Cocaine Dependence
Sponsor
Jennifer Plebani
Locations
1
Primary Endpoint
Varenicline's impact on reinforcing effects of cocaine
Status
Withdrawn
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
August 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Jennifer Plebani
Responsible Party
Sponsor Investigator
Principal Investigator

Jennifer Plebani

Sponsor-Investigator

University of Pennsylvania

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Current DSM-IV diagnosis of any psychoactive substance dependence other than nicotine dependence, as determined by the Structured Clinical Interview for the DSM (SCID).
  • Current severe psychiatric symptoms (e.g., psychosis, dementia, suicidal or homicidal ideation, mania or depression requiring anti-depressant therapy) as diagnosed using the SCID, the Hamilton Anxiety Rating Scale (Ham A), and Hamilton Ration Scale for Depression (HAM-D).
  • Individuals scoring \> 10 on the Hamilton Rating Scale for Depression (HAM-D).
  • Use of any investigational medication within the past 30 days.
  • Concomitant treatment with psychotropic medications.
  • Concomitant use of any one of the following drugs or classes of drugs:
  • Reserpine
  • Verapamil
  • theophylline,
  • trimethoprim,

Arms & Interventions

Varenicline

Intervention: Varenicline

Placebo

Intervention: Varenicline

Outcomes

Primary Outcomes

Varenicline's impact on reinforcing effects of cocaine

Time Frame: 6 weeks

The primary aim of this study is to examine what impact sub-chronic dosing with varenicline has on the subjective and reinforcing effects of cocaine and on cocaine self-administration in cocaine experienced individuals.

Study Sites (1)

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