Varenicline and the Blunting of Cocaine Cues Clinical Trial
Official title:
Assessing the Impact of Varenicline on Brain-Behavior Vulnerability in Cocaine Dependence
| Verified date | September 2016 |
| Source | University of Pennsylvania |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 55 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Pennsylvania Treatment Research Center | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| University of Pennsylvania | National Institute on Drug Abuse (NIDA) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | End of study | No | |
| Secondary | Varenicline (vs. placebo) may reduce positive affective bias to drug (cocaine) cues. | End of study | No |