An interventional study of Smoking Abstinence and Ad Lib Smoking in Cigarette Smoking and Nicotine Withdrawal, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by Duke University · Not applicable, Interventional, and Basic science
This study is designed to find out how smoking affects the way the brain responds to pleasure and how this impacts smokers' behavior. Participants will complete three sessions. The first session will be a screening and training visit to determine final eligibility. Eligible participants will work with a researcher to develop brief scripts about times when they smoke and do other activities. Next, participants will attend two magnetic resonance imaging (MRI) scans - one after abstaining from smoking for 24 hours and the other after smoking as usual. After the second MRI, participants will answer questions on their phone every day for two weeks.
128 studies on the registry are indexed under Substance Withdrawal Syndrome; 8 are open to participants now.
This study's enrollment of 21 is below the median of 53 across 93 interventional studies indexed under Substance Withdrawal Syndrome.
Browse Substance Withdrawal Syndrome studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will abstain from smoking for 24 hours before one MRI scan. Smoking abstinence will be confirmed using exhaled carbon monoxide breath testing
Other: Smoking Abstinence
Participants will continue smoking as usual (i.e. "ad lib") before one MRI scan and smoke one additional cigarette immediately prior to scanning. Continued smoking will be confirmed using exhaled carbon monoxide breath testing.
Other: Ad Lib Smoking
Participants will abstain from smoking for 24 hours.
Participants will continue smoking as usual (i.e. ad lib) and smoke one cigarette of their own brand immediately prior to scanning.
Blood Oxygen Level Dependent (BOLD) Activation
BOLD activation in brain reward network regions
Time frame: Approximately 1-3 weeks
Ecological Momentary Assessment (EMA) Pleasure Ratings
Anticipated and actual pleasure ratings acquired each day during EMA portion of study. Individual items are based on the 12-item Tripartite Pleasure Inventory (TPI). Participants rate their anticipated pleasure for activities they expect to engage in each day using a 0 (No pleasure) to 4 (Extreme pleasure) scale in the morning. They will then rate their actual experienced pleasure for activities they actually did engage in the evening using the same scale. Scores are summed across items for a theoretical range of 0-48.
Time frame: 2-6 weeks
Plan to share: Yes — Detailed protocols, datasets and additional information will be available from the Principal Investigator and research team upon request. In order to maintain compliance with the Health Insurance Portability and Accountability Act (HIPAA) requirements, as well as university data security policies, all data will be anonymized according to HIPAA guidelines prior to being shared. Individual participant scripts will not be made publicly available due to privacy concerns and because this could impact the nature of information participants were willing to provide for scripts. Data will be provided in widely accessible formats for both self-report and imaging data. We will work with the Office of Research Contracts to obtain guidance regarding any required Data Use Agreements as needed.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Substance Withdrawal Syndrome→
Duke University