The Effects of Smoking Withdrawal On Resting State Functional Connectivity

Smoking Clinical Trial

— SmokeAtt04  

Official title:

The Effects of Smoking Withdrawal on Resting State Functional Connectivity

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01632384
• Other study ID #: Pro00031550
• Secondary ID: R01DA023516
• Status: Withdrawn
• Phase: N/A
• First received: February 20, 2012
• Last updated: January 30, 2017
• Start date: February 2012
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Abstain from smoking for 24 hours
Compare smoking satiation to 24 hour smoking abstinence

Locations

Country	Name	City	State
United States	Duke Health Behavior Neuroscience Research Program	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood-oxygen-level-dependent (BOLD) signal	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).	following smoking cigarette 30 minutes prior to scan
Secondary	Blood-oxygen-level-dependent (BOLD) signal	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.	24 hours abstinence