fMRI of Stress in Smoking Behavior

NCT01719471 | Withdrawn DMC

• 2 other identifiers: 0805003898RL1AA017539
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

• No outcome measures for this study, this is an imaging study only

  Upon study completion

Study Arms (2)

Smokers

Nicotine dependent individuals otherwise medically healthy

Healthy

Medically healthy individuals who do not smoke

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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;
• use of any psychoactive medication within past four weeks;
• any significant unstable medical condition such as asthma or heart disease for which increased cardiovascular reactivity during stress challenge might constitute a significant risk;
• IQ\<70 based on past intelligence testing;
• any metal in body that would pose a risk with MRI; and
• claustrophobia that would interfere with MRI;
• alcohol and drug use in the 72 hours prior to scanning, with the exception of tobacco;
• pregnancy for women.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Marc Potenza, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 1, 2012
• Study Start: February 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: December 1, 2014
• Last Updated: December 15, 2014

Record last verified: 2014-12

Locations

US (1)