Cue Induced Imaging in Nicotine Dependent Smokers

October 31, 2012 updated by: Medical University of South Carolina

Validation of Cue Induced Imaging Paradigm in Nicotine Dependent Smokers

The purpose of this study is to evaluate the relationship between craving to smoke and areas activated in brain. The researchers are using functional magnetic resonance imaging (MRI) that measures brain blood flow, or perfusion, to study this brain activation.

Study Overview

Status

Completed

Conditions

Detailed Description

Functional magnetic resonance imaging has demonstrated that the same types of environmental cues that induce craving activate an integrated network of brain areas involved in the appetitive and motivational process of addiction to drugs of abuse including nicotine ( Brieter 119; Koob 2001, Volkow 2003).In nicotine deprived smokers both mesolimbic dopamine reward pathways (amygdala, ventral tegmental area, and medial thalamus) and areas related to visuospatial attention (bilateral prefrontal cortex and parietal cortex and right fusiform gyrus) are activated by exposure to smoking images (Due 2002, David 2005).

In line with the National Institute on Drug Abuse's (NIDA) emphasis on novel methods for investigating substance use disorders, the current study proposes to use fMRI to better understand the neurological correlates of cue reactivity among nicotine dependent smokers. This approach will permit the isolation of pathways that are relevant to cue induced craving.

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult nicotine dependent smokers

Description

Inclusion Criteria (nicotine dependent smoking group):

  1. Age 18 - 60.
  2. Participants will meet criteria for primary nicotine dependence, smoke at least 70% of days in the last 30 days prior to assessment.
  3. Able to read and understand questionnaires and informed consent.
  4. Right-handed.
  5. Currently is not engaged in, and does not want, treatment for nicotine related problems.
  6. Able to maintain abstinence from nicotine during the study period.
  7. Participants must have a negative rapid-screening UDS and pregnancy test prior to imaging session.

Inclusion Criteria (nonsmoking control group):

  1. Age 18 - 60.
  2. Does not meet the DSM-IV criterion for lifetime or current substance dependence.
  3. Has used tobacco products no more than on experimental basis (none in past year).
  4. Participants must have a negative rapid-screening UDS and pregnancy test prior to session.
  5. Righthanded.

Exclusion Criteria (all participants):

  1. Currently meets DSM-IV criteria for any other psychoactive substance dependence disorder except nicotine dependence.
  2. Any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.
  3. Meets DSM-IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder. The rationale for excluding them is that symptoms from these disorders may affect dependent variables and complicate interpretation of the data.
  4. Has current suicidal ideation with plan or homicidal ideation.
  5. Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.
  6. Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit ability to participate in scan.
  7. Sexually active females of child-bearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
  8. Has current charges pending for a violent crime (not including DUI related offenses).
  9. Persons with ferrous metal implants or pacemaker since fMRI will be used.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Non-smoker
Non-smoking control
Nicotine Dependent Smoking Group
current smokers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Karen Hartwell, MD, Medical Universtiy of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 13, 2009

First Posted (ESTIMATE)

February 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2012

Last Update Submitted That Met QC Criteria

October 31, 2012

Last Verified

October 1, 2009

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nicotine Dependence

Subscribe