Assessing the Impact of Varenicline on Brain-Behavior Vulnerability
Withdrawn before enrolling · Phase 2
Conditions studied: Varenicline and the Blunting of Cocaine Cues
In brief
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.
Key facts
- Study ID
- NCT00895557
- Run by
- University of Pennsylvania
- People needed
- 0
- Starts
- 2007-12-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2016-09-08
Who can join
Age: 18 and older, up to 55. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Physically healthy male substance abuse subjects age 18-55.
You may not qualify if…
- 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
Where it is running
- University of Pennsylvania Treatment Research Center — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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