fMRI of Stress in Smoking Behavior

Smoking Clinical Trial

Official title:

fMRI of Stress in Smoking Behavior

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01719471
• Other study ID #: 0805003898
• Secondary ID: RL1AA017539
• Status: Withdrawn
• Phase: N/A
• First received: October 29, 2012
• Last updated: December 12, 2014
• Start date: February 2008
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Smoking

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No outcome measures for this study, this is an imaging study only		Upon study completion	No