Overview

Assessing the Impact of Varenicline on Brain-Behavior Vulnerability

Status:
Withdrawn
Trial end date:
2013-12-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Pennsylvania
Collaborator:
National Institute on Drug Abuse (NIDA)
Treatments:
Cocaine
Varenicline
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