Cigarette Smoking, Nicotine Withdrawal
Conditions
Brief summary
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.
Interventions
OTHERSmoking Abstinence
Participants will abstain from smoking for 24 hours.
OTHERAd Lib Smoking
Participants will continue smoking as usual (i.e. ad lib) and smoke one cigarette of their own brand immediately prior to scanning.
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Food and Drug Administration (FDA)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Participants will abstain from smoking for 24 hours before one MRI scan and continue smoking as usual before the other.
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Generally healthy * Right-handed * Smoke \>= 10 cigarettes per day * Smoking regularly for \>= 1 year * Carbon Monoxide (CO) \> 8 at screening (or urinary cotinine \> 100) * Own a compatible smartphone * Able to read and understand English * Able to identify at least 4 pleasurable activities they do not do concurrently with smoking or associate with smoking
Exclusion criteria
* Regular use of roll your own cigarettes * Planning to quit smoking within the next 60 days * Current or planned smoking cessation treatment * Regular use of smokeless tobacco or other nicotine products * Expired CO \> 80 parts per million * Breath alcohol \> .000 at screening (re-attempts are allowed) * Positive toxicology screen for exclusionary drugs * Use of exclusionary medications * Significant medical problems * Currently breastfeeding, pregnant, or planning to become pregnant * Enrollment in another study utilizing Spectrum cigarettes within the last 3 months * Irregular slee-wake cycles (e.g. swing-shift work, unusual sleep patterns)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Oxygen Level Dependent (BOLD) Activation | Approximately 1-3 weeks | BOLD activation in brain reward network regions |
| Ecological Momentary Assessment (EMA) Pleasure Ratings | 2-6 weeks | 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. |
Countries
United States
Outcome results
None listed