Cue Induced Imaging in Nicotine Dependent Smokers

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00844701
First received: February 12, 2009
Last updated: October 31, 2012
Last verified: October 2009
  Purpose

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.


Condition
Nicotine Dependence

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Validation of Cue Induced Imaging Paradigm in Nicotine Dependent Smokers

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Enrollment: 52
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Non-smoker
Non-smoking control
Nicotine Dependent Smoking Group
current smokers

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

adult nicotine dependent smokers

Criteria

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.
  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: NCT00844701

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Karen Hartwell, MD Medical Universtiy of South Carolina
  More Information

No publications provided

Responsible Party: Karen Hartwell, M.D., Medical University of South Carolina - Clinical Neuroscience Division
ClinicalTrials.gov Identifier: NCT00844701     History of Changes
Other Study ID Numbers: BOLD fMRI
Study First Received: February 12, 2009
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
nicotine
addiction
fMRI
neuroimaging
neurobiology
craving

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014