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Impact of Varenicline on Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation on Smokers (GRAND)

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00934024
First received: July 6, 2009
Last updated: October 31, 2012
Last verified: May 2010
History of Changes
  Purpose

The purpose of this study is to evaluate the impact of varenicline treatment on cue induced craving to smoking using brain imaging. The investigators hypothesize that participants will report reduced urges to smoke and will have less activation in parts of the brain associated with craving.


Condition Intervention
Nicotine Dependence
 Drug: varenicline

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Impact of Varenicline on Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation on Smokers (GRAND)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Regional brain activation in response to craving from cues to smoke [ Time Frame: 3 1/2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Smoking cessation [ Time Frame: 3 1/2 months ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: April 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: varenicline
    Participants will be treated with a standard course of varenicline, 0.5 mg 1 tablet every day for 3 days, then 0.5 mg 1 tab twice a day for four days, and 1 mg 1 tablet twice a day for three months.
    Other Name: Chantix
Detailed Description:

Treatment with varenicline reduces overall subjective cigarette craving and smoking reward in nicotine-dependent smokers. This preliminary study will explore the impact of varenicline treatment on smoking cue-induced craving and associated regional brain activation using BOLD fMRI. Twenty healthy smokers (10 males, 10 females) will undergo two BOLD fMRI scans with the presentation of smoking-related and neutral cues at baseline and after five weeks of treatment with open-label varenicline. The investigators hypothesize that participants will report reduced urges to smoke on the Questionnaire of Smoking Urges-Brief and have less activation of the brain areas associated with craving during the fMRI after 5 weeks of varenicline and smoking cessation counseling compared to the baseline scan.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 21 - 60 treatment-seeking right handed smokers.
  2. Meet criteria for primary nicotine dependence confirmed by FTND and smoked at least 70% of days in the last 30 days prior to assessment.
  3. General good health confirmed by history & physical.
  4. Able to read and understand questionnaires and informed consent.
  5. Motivated to quit, willing to set a target quit date (TQD) and abstain from smoking after TDQ.
  6. Participants must have a negative urine drug screen (UDS) and pregnancy test prior to imaging sessions and beginning varenicline treatment.
  7. Female participants will use a reliable method of birth control throughout the study.
  8. Demonstrate subjective response to cues in a laboratory cue reactivity session.

Exclusion Criteria:

  1. Currently meets DSM-IV criteria for any other psychoactive substance dependence disorder except nicotine dependence.
  2. Any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.
  3. Use of other tobacco products.
  4. Current use of nicotine replacement therapy, bupropion, or other smoking cessation treatment.
  5. Previous failed attempt on varenicline.
  6. Meets DSM-IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder.
  7. Current suicidal ideation with plan or homicidal ideation.
  8. Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI.
  9. Clinically significant medical problems that would impair participation or limit ability to participate in scan.
  10. Sexually active females of child-bearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
  11. Has current charges pending for a violent crime (not including DUI related offenses).
  12. Persons with ferrous metal implants or pacemaker since fMRI will be used.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00934024

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Karen Hartwell, M.D. Medical Universtiy of South Carolina
  More Information

No publications provided

Responsible Party: Karen Hartwell, M.D., Medical University of South Carolina - Clinical Neuroscience Division
ClinicalTrials.gov Identifier: NCT00934024     History of Changes
Other Study ID Numbers: HR#18521
Study First Received: July 6, 2009
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
nicotine dependence
tobacco
smoking

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
 Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013