- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00844701
Cue Induced Imaging in Nicotine Dependent Smokers
Validation of Cue Induced Imaging Paradigm in Nicotine Dependent Smokers
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria (nicotine dependent smoking group):
- Age 18 - 60.
- Participants will meet criteria for primary nicotine dependence, smoke at least 70% of days in the last 30 days prior to assessment.
- Able to read and understand questionnaires and informed consent.
- Right-handed.
- Currently is not engaged in, and does not want, treatment for nicotine related problems.
- Able to maintain abstinence from nicotine during the study period.
- Participants must have a negative rapid-screening UDS and pregnancy test prior to imaging session.
Inclusion Criteria (nonsmoking control group):
- Age 18 - 60.
- Does not meet the DSM-IV criterion for lifetime or current substance dependence.
- Has used tobacco products no more than on experimental basis (none in past year).
- Participants must have a negative rapid-screening UDS and pregnancy test prior to session.
- Righthanded.
Exclusion Criteria (all participants):
- Currently meets DSM-IV criteria for any other psychoactive substance dependence disorder except nicotine dependence.
- Any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.
- 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.
- Has current suicidal ideation with plan or homicidal ideation.
- Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.
- Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit ability to participate in scan.
- 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.
- Has current charges pending for a violent crime (not including DUI related offenses).
- Persons with ferrous metal implants or pacemaker since fMRI will be used.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Non-smoker
Non-smoking control
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Nicotine Dependent Smoking Group
current smokers
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Collaborators and Investigators
Investigators
- Principal Investigator: Karen Hartwell, MD, Medical Universtiy of South Carolina
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BOLD fMRI
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
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Washington University School of MedicineNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Nicotine Dependence | Tobacco Dependence | Smoking, Tobacco | Nicotine Use Disorder | Nicotine Dependence, Cigarettes | Smoking, Cigarette | Nicotine Dependence Tobacco Product | Tobacco; Use, Rehabilitation | Smoking (Tobacco) Addiction and other conditionsUnited States
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Semmelweis UniversityCompleted
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