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

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.

Study Overview

• Status: Terminated
• Conditions: Cigarette Smoking; Nicotine Withdrawal
• Intervention / Treatment: Other: Smoking Abstinence; Other: Ad Lib Smoking

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 10, 2019
• Primary Completion (ACTUAL): May 13, 2021
• Study Completion (ACTUAL): May 13, 2021

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (ACTUAL): February 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Substance Withdrawal Syndrome
• Other Study ID Numbers: Pro00101055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: We anticipate making data available within 6 months of study completion. It will be available for an indefinite period of time.
• IPD Sharing Access Criteria: Contact PI for details.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No