NCT01632384

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 2, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2013

Enrollment Period

7 months

First QC Date

February 20, 2012

Last Update Submit

January 30, 2017

Conditions

Smoking

Keywords

SmokerNon-SmokerHealthyDrug freeMRI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Blood-oxygen-level-dependent (BOLD) signal

    24 hours abstinence

Interventions

Abstain from smoking for 24 hoursBEHAVIORAL

Compare smoking satiation to 24 hour smoking abstinence

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Left handed/ambidextrous
  • Currently taking medication
  • Interested in quitting long term

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Health Behavior Neuroscience Research Program

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Francis J McClernon, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2012

First Posted

July 2, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 31, 2017

Record last verified: 2013-01

Locations

US(1)