The Neural Basis of Cue-Elicited Cigarette Craving and Its Control
|ClinicalTrials.gov Identifier: NCT01048957|
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : June 20, 2018
- One kind of drug craving, known as cue-elicited craving, occurs when a drug user who sees a drug-related cue (such as an image of someone using the drug) begins to feel a craving for the drug. Researchers are interested in studying how cue-elicited craving affects brain activity using functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) data.
- To determine which parts of the brain are associated with or involved in controlling cue-related craving in smokers.
- Individuals between 18 and 50 years of age who are current smokers (10 or more cigarettes per day) and agree to try to abstain from smoking for 1 week during the experiment.
- Participants will visit a clinical center for up to four scanning sessions, and will be asked to perform two or three outpatient tasks at home over the course of the study.
- Scan 1: Training session with a mock fMRI scanner, followed by an actual fMRI scanning session and EEG in which participants respond to pictures.
- Outpatient Task 1: Tolerance test with nicotine patch (worn for 8 hours, followed by 12 additional hours without cigarette use).
- Scans 2 and 3: Training session and fMRI scan and testing with either nicotine patch or placebo. Tasks in fMRI involve looking at cues, reporting craving and suppressing craving.
- Outpatient Task 2: Participants will keep an electronic diary for 10 to 14 days, responding to questions as directed by the researchers.
- Scans 4 and 5: Training session, fMRI scan and EEG, and testing in which participants will be instructed on methods to attempt to control cravings.
- Outpatient Task 3: Participants will keep an electronic diary for 14 days. For the first 7 days, participants will be asked to attempt to abstain from nicotine; participants may smoke normally on the second 7 days.
- Participants will be contacted 1, 3, 6, and 12 months after the end of the study for follow-up questions on current smoking habits.
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Behavioral: Real Time Feedback Training||Not Applicable|
Objective: Drug craving is a motivational state associated with a conscious desire to consume a drug (Fredrickson et al., 1995; Drummond, 2001). When drug abusers see drug-related cues, cue-elicited drug craving is induced (Drummond, 2001). The main goal of this investigation is to ascertain the neural basis of cue-elicited drug (e.g. cigarette) craving and its control in smokers.
Study population: The experimental population for this investigation is nicotine-dependent adults aged 18-50 years old.
Design: Participants will see the smoking-related cue or neutral cue and complete cognitive tasks (e.g. to report or regulate their craving, etc). At same time, we will employ functional magnetic resonance imaging (fMRI), real-time functional magnetic resonance imaging (rtfMRI), and electroencephalography (EEG) to measure brain activity.
Outcome measures: There is no direct benefit to the participant by joining this study. Data from this study are expected to contribute to a better understanding of the neural processes of cigarette craving. Thus, the results may benefit the health of society. MRI-related risks (e.g., injury from metal implants, claustrophobia, and temporary hearing threshold alterations due to the loud banging noises) and nicotine-patch-related risks (e.g., dizziness, headache, upset stomach, vomiting, diarrhea, redness or swelling at the patch site) to participants are minimized by careful prescreening and standard protection.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||79 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||The Neural Basis of Cue-Elicited Cigarette Craving and Its Control|
|Study Start Date :||January 9, 2007|
|Actual Primary Completion Date :||April 8, 2013|
|Actual Study Completion Date :||April 8, 2013|
- To ascertain the neural basis of cue-elicited drug (e.g. cigarette) craving and its control in smokers.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048957
|United States, Maryland|
|National Institute on Drug Abuse, Biomedical Research Center (BRC)|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Elliot Stein, Ph.D.||National Institute on Drug Abuse (NIDA)|