Assessing the Impact of Varenicline on Brain-Behavior Vulnerability

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania Identifier:
First received: May 7, 2009
Last updated: April 11, 2012
Last verified: April 2012

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.

Condition Intervention Phase
Varenicline and the Blunting of Cocaine Cues
Drug: chantix
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Assessing the Impact of Varenicline on Brain-Behavior Vulnerability in Cocaine Dependence

Resource links provided by NLM:

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Varenicline (vs. placebo) may reduce positive affective bias to drug (cocaine) cues. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: chantix Drug: chantix
.5 mg once a day 1 to 3, .5 mg twice a day on days 4 to 7, 1 mg from day 8 to end of treatment
Other Name: varenicline


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00895557

United States, Pennsylvania
University of Pennsylvania Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Principal Investigator: Anna Rose Childress, Ph.D. University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania Identifier: NCT00895557     History of Changes
Other Study ID Numbers: 807134  1P50DA012756  Supplement  DPMC 
Study First Received: May 7, 2009
Last Updated: April 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
brain imaging

Additional relevant MeSH terms:
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs processed this record on February 09, 2016