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

Primary Purpose

Cigarette Smoking, Nicotine Withdrawal

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smoking Abstinence
Ad Lib Smoking
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cigarette Smoking

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts 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)

Sites / Locations

  • Duke University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Smoking Abstinence

Ad Lib Smoking

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Blood Oxygen Level Dependent (BOLD) Activation
BOLD activation in brain reward network regions
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.

Secondary Outcome Measures

Full Information

First Posted
February 12, 2019
Last Updated
May 18, 2021
Sponsor
Duke University
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), Food and Drug Administration (FDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03840694
Brief Title
Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior
Acronym
NicWith
Official Title
Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
PI leaving for another institution.
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
May 13, 2021 (Actual)
Study Completion Date
May 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), Food and Drug Administration (FDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cigarette Smoking, Nicotine Withdrawal

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will abstain from smoking for 24 hours before one MRI scan and continue smoking as usual before the other.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smoking Abstinence
Arm Type
Other
Arm Description
Participants will abstain from smoking for 24 hours before one MRI scan. Smoking abstinence will be confirmed using exhaled carbon monoxide breath testing
Arm Title
Ad Lib Smoking
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Smoking Abstinence
Intervention Description
Participants will abstain from smoking for 24 hours.
Intervention Type
Other
Intervention Name(s)
Ad Lib Smoking
Intervention Description
Participants will continue smoking as usual (i.e. ad lib) and smoke one cigarette of their own brand immediately prior to scanning.
Primary Outcome Measure Information:
Title
Blood Oxygen Level Dependent (BOLD) Activation
Description
BOLD activation in brain reward network regions
Time Frame
Approximately 1-3 weeks
Title
Ecological Momentary Assessment (EMA) Pleasure Ratings
Description
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.
Time Frame
2-6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason A Oliver, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University School of Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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