fMRI of Stress in Smoking Behavior

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01719471
First received: October 29, 2012
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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


Condition
Smoking

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: fMRI of Stress in Smoking Behavior

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • No outcome measures for this study, this is an imaging study only [ Time Frame: Upon study completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2008
Estimated Study Completion Date: February 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Smokers
Nicotine dependent individuals otherwise medically healthy
Healthy
Medically healthy individuals who do not smoke

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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

Criteria

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.
  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: NCT01719471

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Marc Potenza, MD, PhD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01719471     History of Changes
Other Study ID Numbers: 0805003898, RL1AA017539
Study First Received: October 29, 2012
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 26, 2014