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The Effects of Smoking Withdrawal On Resting State Functional Connectivity (SmokeAtt04)

This study has been withdrawn prior to enrollment.
(study close-out)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01632384
First received: February 20, 2012
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to see how the brain differs between smoking regularly and after not smoking for 24 hours. The investigators will be using an MRI machine to get the information from adult smokers and non-smokers while they lie in the scanner with their eyes closed. Smokers will be scanned when they have not smoked for 24 hrs and shortly after smoking. It is our hypothesis that brain activity will be altered after not smoking for 24 hours.


Condition Intervention
Smoking
Behavioral: Abstain from smoking for 24 hours

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Effects of Smoking Withdrawal on Resting State Functional Connectivity

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Blood-oxygen-level-dependent (BOLD) signal [ Time Frame: following smoking cigarette 30 minutes prior to scan ] [ Designated as safety issue: No ]
    Smokers will be scanned after smoking to satiety. In order to be considered satiated, smokers will have to be regular smokers (smoking daily for at least 2 years).


Secondary Outcome Measures:
  • Blood-oxygen-level-dependent (BOLD) signal [ Time Frame: 24 hours abstinence ] [ Designated as safety issue: No ]
    Smokers will be asked to stop smoking 24 hours prior to the scan without the aid of nicotine replacement therapies. They will resume smoking as usual 24 hours after the scan.


Enrollment: 0
Study Start Date: February 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Abstain from smoking for 24 hours
    Compare smoking satiation to 24 hour smoking abstinence
Detailed Description:

The broad objective of this proposal is to identify functional neuroanatomical correlates of changes in brain functional connectivity during smoking abstinence. The investigators will measure changes in regional blood oxygenation levels using fMRI while adult smokers and non-smokers lie in the scanner with their eyes closed. Smokers will be scanned when they are abstinent from smoking for 24 hrs and shortly after smoking. Our primary hypothesis is that smoking abstinence will alter resting state brain activity (or resting state functional connectivity; RSFC) across widely distributed neural networks and that high-resolution fMRI will help in resolving the exact nature of such changes. Data will be analyzed using methods developed in our laboratory and applied to other resting state datasets. All of the procedures used in the study are well validated and introduce only minor risk to participants (e.g. blood draw; MRI).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Right handed
  • Drug free
  • No known health problems
  • Currently not taking any medication
  • Uninterested in quitting smoking long term

Exclusion Criteria:

  • Left handed/ambidextrous
  • Currently taking medication
  • Interested in quitting long term
  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 ClinicalTrials.gov identifier: NCT01632384

Locations
United States, North Carolina
Duke Health Behavior Neuroscience Research Program
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Francis J McClernon, Ph.D. Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01632384     History of Changes
Other Study ID Numbers: Pro00031550, R01DA023516
Study First Received: February 20, 2012
Last Updated: January 10, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Duke University:
Smoker
Non-Smoker
Healthy
Drug free
MRI

ClinicalTrials.gov processed this record on November 20, 2014