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

• ClinicalTrials.gov Identifier: NCT03840694
• Recruitment Status: Terminated
• First Posted: February 15, 2019
• Last Update Posted: May 20, 2021
• Sponsor: Duke University
• Collaborators: National Institutes of Health (NIH); National Institute on Drug Abuse (NIDA); Food and Drug Administration (FDA)
• Information provided by (Responsible Party): Duke University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cigarette Smoking; Nicotine Withdrawal	Other: Smoking Abstinence; Other: Ad Lib Smoking	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Participants will abstain from smoking for 24 hours before one MRI scan and continue smoking as usual before the other.
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior
• Actual Study Start Date: September 10, 2019
• Actual Primary Completion Date: May 13, 2021
• Actual Study Completion Date: May 13, 2021

Arms and Interventions

Arm	Intervention/treatment
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	Other: Smoking Abstinence; Participants will abstain from smoking for 24 hours.
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.	Other: Ad Lib Smoking; Participants will continue smoking as usual (i.e. ad lib) and smoke one cigarette of their own brand immediately prior to scanning.

Outcome Measures

Primary Outcome Measures :

1. Blood Oxygen Level Dependent (BOLD) Activation [ Time Frame: Approximately 1-3 weeks ]
   BOLD activation in brain reward network regions
2. Ecological Momentary Assessment (EMA) Pleasure Ratings [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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)

Contacts and Locations

Locations

United States, North Carolina

Duke University School of Medicine

Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Duke University

National Institutes of Health (NIH)

National Institute on Drug Abuse (NIDA)

Food and Drug Administration (FDA)

Investigators

• Principal Investigator: Jason A Oliver, PhD; Duke University

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03840694
• Other Study ID Numbers: Pro00101055
• First Posted: February 15, 2019
• Last Update Posted: May 20, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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 Materials: 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Substance Withdrawal Syndrome; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders