fMRI of Stress in Smoking Behavior

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

Study Overview

• Status: Withdrawn
• Conditions: Smoking

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

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

30 tobacco dependent and 30 matched healthy controls who have never smoked will be recruited for this study

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Smokers; Nicotine dependent individuals otherwise medically healthy
Healthy; Medically healthy individuals who do not smoke

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
No outcome measures for this study, this is an imaging study only	Upon study completion

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Marc Potenza, MD, PhD, Yale University

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: October 29, 2012
• First Posted (Estimate): November 1, 2012

Study Record Updates

• Last Update Posted (Estimate): December 15, 2014
• Last Update Submitted That Met QC Criteria: December 12, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 0805003898; RL1AA017539 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No