Working... Menu

Assessing the Impact of Varenicline on Brain-Behavior Vulnerability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00895557
Recruitment Status : Withdrawn (This study never started, no funding.)
First Posted : May 8, 2009
Last Update Posted : September 8, 2016
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Varenicline and the Blunting of Cocaine Cues Drug: chantix Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Assessing the Impact of Varenicline on Brain-Behavior Vulnerability in Cocaine Dependence
Study Start Date : December 2007
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Varenicline (vs. placebo) may reduce positive affective bias to drug (cocaine) cues. [ Time Frame: End of study ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00895557

Layout table for location information
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)
Layout table for investigator information
Principal Investigator: Anna Rose Childress, Ph.D. University of Pennsylvania

Layout table for additonal information
Responsible Party: University of Pennsylvania Identifier: NCT00895557     History of Changes
Other Study ID Numbers: 807134
1P50DA012756 ( U.S. NIH Grant/Contract )
Supplement ( Other Grant/Funding Number: P50-DA012756 )
DPMC ( Other Identifier: NIDA )
First Posted: May 8, 2009    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016

Keywords provided by University of Pennsylvania:
brain imaging

Additional relevant MeSH terms:
Layout table for MeSH terms
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics, Local
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents