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

Not Applicable

Terminated

• Conditions: Nicotine Withdrawal; Cigarette Smoking
• Interventions: Other: Smoking Abstinence; Other: Ad Lib Smoking

• Registration Number: NCT03840694
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-12
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Study Start: 2019-09-10
• Status Verified: 2021-05
• Primary Completion: 2021-05-13
• Study Completion: 2021-05-13
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Smoking Abstinence	Smoking Abstinence	Participants will abstain from smoking for 24 hours before one MRI scan. Smoking abstinence will be confirmed using exhaled carbon monoxide breath testing
Ad Lib Smoking	Ad Lib Smoking	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Duke University School of Medicine; 🇺🇸 Durham, North Carolina, United States