fMRI of Stress in Smoking Behavior

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: NCT01719471
Recruitment Status : Withdrawn (No subjects enrolled)
First Posted : November 1, 2012
Last Update Posted : December 15, 2014
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University

Brief Summary:
To examine the influence of current daily tobacco smoking on brain activation during stress, tobacco cue, and neutral relaxing conditions

Condition or disease

Detailed Description:
Subjects will participate in an fMRI session to examine changes in frontal and limbic brain regions with tobacco cues, stress and neutral/relaxing imagery. During each fMRI session subjects will participate in six imagery trials: 2 different neutral/relaxing, 2 different stress and 2 different tobacco cue scripts.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: fMRI of Stress in Smoking Behavior
Study Start Date : February 2008
Actual Primary Completion Date : February 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Nicotine dependent individuals otherwise medically healthy
Medically healthy individuals who do not smoke

Primary Outcome Measures :
  1. No outcome measures for this study, this is an imaging study only [ Time Frame: Upon study completion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
30 tobacco dependent and 30 matched healthy controls who have never smoked will be recruited for this study

Inclusion Criteria:

  1. age 18-50 years inclusive;
  2. able to read and write English;
  3. for women, being in follicular phase of menstrual cycle;

5) Tobacco dependent sample: smokes 10 or more cigarettes daily for the past year; Non-smokers, no tobacco consumption for more than one year and never having used tobacco daily.

Exclusion Criteria:

  1. any major neurological illness or injury and any current or prior clinically significant mental health (including PTSD) or substance use disorder (with possible exception of nicotine dependence) as determined by SCID interview;
  2. use of any psychoactive medication within past four weeks;
  3. any significant unstable medical condition such as asthma or heart disease for which increased cardiovascular reactivity during stress challenge might constitute a significant risk;
  4. IQ<70 based on past intelligence testing;
  5. any metal in body that would pose a risk with MRI; and
  6. claustrophobia that would interfere with MRI;
  7. alcohol and drug use in the 72 hours prior to scanning, with the exception of tobacco;
  8. pregnancy for women.

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): NCT01719471

United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Marc Potenza, MD, PhD Yale University

Responsible Party: Yale University Identifier: NCT01719471     History of Changes
Other Study ID Numbers: 0805003898
RL1AA017539 ( U.S. NIH Grant/Contract )
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: December 15, 2014
Last Verified: December 2014