Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior (NicWith)

Duke University

Status: Terminated

Conditions: Cigarette Smoking; Nicotine Withdrawal

Treatments: Other: Ad Lib Smoking; Other: Smoking Abstinence

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT03840694

Pro00101055

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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21 participants in 2 patient groups

Smoking Abstinence

Other group

Description:

Participants will abstain from smoking for 24 hours before one MRI scan. Smoking abstinence will be confirmed using exhaled carbon monoxide breath testing

Treatment:

Other: Smoking Abstinence

Ad Lib Smoking

Other group

Description:

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.

Treatment:

Other: Ad Lib Smoking