Trials / Completed
CompletedNCT01048957
The Neural Basis of Cue-Elicited Cigarette Craving and Its Control
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 79 (actual)
- Sponsor
- National Institute on Drug Abuse (NIDA) · NIH
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
Background: \- 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. Objectives: \- To determine which parts of the brain are associated with or involved in controlling cue-related craving in smokers. Eligibility: \- 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. Design: * 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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Real Time Feedback Training |
Timeline
- Start date
- 2007-01-09
- Primary completion
- 2013-04-08
- Completion
- 2013-04-08
- First posted
- 2010-01-14
- Last updated
- 2019-12-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01048957. Inclusion in this directory is not an endorsement.