Assessing the Impact of Varenicline on Brain-Behavior Vulnerability
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Varenicline and the Blunting of Cocaine Cues
Intervention: chantix (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Pennsylvania Official(s) and/or principal investigator(s):
Anna Rose Childress, Ph.D., Principal Investigator, Affiliation: University of Pennsylvania
Overall contact:
Anna Fornash, BA, Phone: 215-222-3200, Ext: 165, Email: fornash_a@mail.trc.upenn.edu
Summary
Our proposal will enable us to study cocaine patients to determine whether varenicline can
weaken brain arousal to drug cues in an fMRI imaging setting, which is what we theorize.
This supplement supports a pilot imaging study in cocaine dependence. It will evaluate the
impact of varenicline on the brain response to ultra-brief drug and comparison cues in an
event-related fMRI paradigm. This is a pilot study.
We will additionally examine the impact of varenicline on addiction-relevant behavioral
probes of impulsivity, inhibition, attentional and affective bias. The proposed study will
provide the first brain-behavioral probes of varenicline's cocaine-relevant actions in
humans, and will provide the critical scientific rationale to move the agent into future
collaborative clinical trials.
Clinical Details
Official title: Assessing the Impact of Varenicline on Brain-Behavior Vulnerability in Cocaine Dependence
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Primary outcome: To determine whether varenicline, as compared to placebo, can blunt the limbic activation (e.g., amygdala, ventral striatum/ventral pallidum, etc.) by ultra-brief cocaine cues using fast event-related fMRI.
Secondary outcome: Varenicline (vs. placebo) may reduce positive affective bias to drug (cocaine) cues.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Physically healthy male substance abuse subjects age 18-55.
Exclusion Criteria:
- 1) Participation in clinical trial and receipt of investigational drug(s) during
previous 60 days 2) Clinically significant cardiovascular, hematologic, hepatic,
renal, neurological or endocrinological abnormalities 3) History of serious head
trauma or injury causing loss of consciousness that lasted more than 3 minutes. 4)
Presence of magnetically active prosthetics, plates, pins, broken needles, permanent
retainer, bullets, etc. in subject's body (unless a radiologist confirms that its
presence is unproblematic). A x-ray may be obtained to determine eligibility. 5)
Claustrophobia or other medical condition disabling subject from lying in the MRI for
approximately 60 minute
Locations and Contacts
Anna Fornash, BA, Phone: 215-222-3200, Ext: 165, Email: fornash_a@mail.trc.upenn.edu
University of Pennsylvania Treatment Research Center, Philadelphia, Pennsylvania 19104, United States; Recruiting
Anna Fornash, Phone: 215-222-3200, Ext: 165
Additional Information
Starting date: December 2007
Last updated: December 2, 2009
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