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

NCT03840694 | Terminated

• 1 other identifier: Pro00101055
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking; Nicotine Withdrawal

Outcome Measures

Primary Outcomes (2)

• Blood Oxygen Level Dependent (BOLD) Activation

  BOLD activation in brain reward network regions

  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.

  2-6 weeks

Study Arms (2)

Smoking Abstinence

OTHER

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

Ad Lib Smoking

OTHER

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

Interventions

Smoking Abstinence OTHER

Participants will abstain from smoking for 24 hours.

Smoking Abstinence

Ad Lib Smoking OTHER

Participants will continue smoking as usual (i.e. ad lib) and smoke one cigarette of their own brand immediately prior to scanning.

Ad Lib Smoking

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Duke University School of Medicine

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Jason A Oliver, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will abstain from smoking for 24 hours before one MRI scan and continue smoking as usual before the other.

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 15, 2019
• Study Start: September 10, 2019
• Primary Completion: May 13, 2021
• Study Completion: May 13, 2021
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: We anticipate making data available within 6 months of study completion. It will be available for an indefinite period of time.
• Access Criteria: Contact PI for details.

Locations

US (1)