Nicotine Withdrawal and Reward Processing (NicWith)
Primary Purpose
Cigarette Smoking, Nicotine Dependence, Nicotine Withdrawal
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smoking Abstinence
Ad Lib Smoking
Sponsored by
About this trial
This is an interventional basic science trial for Cigarette Smoking
Eligibility Criteria
Inclusion Criteria:
- Generally healthy
- Age 21-55
- Right-handed using a three-item scale
- Daily smoker of ≥ 10 cigarettes/day
- Smoking regularly for ≥ 1 year
- Have a smartphone capable of running the MetricWire application
- 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:
- Planning to quit smoking within the next 60 days
- Currently seeking or receiving treatment for smoking cessation
- Use of smokeless tobacco, nicotine replacement products or electronic cigarettes more than 5 days in the past month.
- Breath alcohol level ≥.001. Participants may be allowed one reschedule at the discretion of the PI or other study staff.
Positive toxicology screen for illicit drugs
- Marijuana will be tested for but will not exclusionary
- Participants failing the toxicology screen may be allowed one re-screening attempt at the PI's discretion
- Participants with valid prescriptions who report using the medication as directed and meet all other eligibility criteria may be allowed to participate at the PI's discretion
- Current use of antipsychotic or stimulant medications.
Significant health problems or those that would impact scientific goals of the project, including (but not limited to):
- Cancer, Bronchitis, Emphysema, COPD
- Asthma or Breathing Problems
- Insulin-Dependent Diabetes
- Heart disease, angina, heart failure, serious arrhythmia or heart attack within the past 6 months
- Systolic Blood Pressure > 160, Diastolic Blood Pressure > 100, HR > 115 bpm (one re-screen allowed).
- Glaucoma, color blindness or an uncorrected vision problem
- Significant hearing loss requiring the use of hearing aids or other hearing problems that would impact
- History of stroke, brain tumor, seizure disorder, or traumatic brain injury
- Metal implants (e.g. pacemaker, surgical pins, certain dental repairs), dental braces, or metal fragment injuries.
- Claustrophobia
- Weight > 300 pounds or unable to fit in the MRI scanner bore
- Current depression, bipolar disorder, psychotic disorder or substance use disorder (moderate or severe only, mild is allowable at PI's discretion). SUD in remission is also allowable at PI's discretion
- Pregnant, breastfeeding or planning to become pregnant during the course of the study (females)
- Current enrollment in another smoking research study or having participated in a study involving daily use of Spectrum cigarettes or other reduced nicotine products within the past three months
- Irregular sleep-wake cycles (e.g. swing-shift work, unusual sleep pattern)
Sites / Locations
- Hardesty Center for Clinical Research and NeuroscienceRecruiting
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 experienced pleasure based on self-report ratings acquired each day during the EMA phase
Secondary Outcome Measures
Full Information
NCT ID
NCT05041959
First Posted
September 3, 2021
Last Updated
August 7, 2023
Sponsor
University of Oklahoma
Collaborators
Oklahoma State University, National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05041959
Brief Title
Nicotine Withdrawal and Reward Processing
Acronym
NicWith
Official Title
Nicotine Withdrawal and Reward Processing
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
Oklahoma State University, National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
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 Dependence, 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
None (Open Label)
Masking Description
This is a smoking abstinence manipulation. No masking is possible.
Allocation
Randomized
Enrollment
150 (Anticipated)
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) in the day leading up to the scan 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 2-4 weeks
Title
Ecological Momentary Assessment (EMA) Pleasure Ratings
Description
Anticipated and experienced pleasure based on self-report ratings acquired each day during the EMA phase
Time Frame
2-4 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
Age 21-55
Right-handed using a three-item scale
Daily smoker of ≥ 6 cigarettes/day
Smoking regularly for ≥ 1 year
Have a smartphone capable of running the MetricWire application
Able to read and understand English
Able to identify at least 6 pleasurable activities they do not do concurrently with smoking or associate with smoking.
Able to identify at least 6 unique locations/scenarios they do associate with smoking
Exclusion Criteria:
Planning to quit smoking within the next 60 days
Currently seeking or receiving treatment for smoking cessation
Use of smokeless tobacco, nicotine replacement products or electronic cigarettes more than 5 days in the past month.
Breath alcohol level ≥.001. Participants may be allowed one reschedule at the discretion of the PI or other study staff.
Positive toxicology screen for illicit drugs
Marijuana will be tested for but will not be exclusionary
Participants failing the toxicology screen may be allowed one re-screening attempt at the PI's discretion
Participants with valid prescriptions who report using the medication as directed and meet all other eligibility criteria may be allowed to participate at the PI's discretion
Current use of antipsychotic or stimulant medications.
Significant health problems or those that would impact scientific goals of the project, including (but not limited to):
Cancer, Bronchitis, Emphysema, COPD
Asthma or Breathing Problems
Insulin-Dependent Diabetes
Heart disease, angina, heart failure, serious arrhythmia or heart attack within the past 6 months
Systolic Blood Pressure > 160, Diastolic Blood Pressure > 100, HR > 115 bpm (one re-screen allowed).
Glaucoma, color blindness or an uncorrected vision problem
Significant hearing loss requiring the use of hearing aids or other hearing problems that would impact
History of stroke, brain tumor, seizure disorder, or traumatic brain injury
Metal implants (e.g. pacemaker, surgical pins, certain dental repairs), dental braces, or metal fragment injuries.
Claustrophobia
Weight > 350 pounds or unable to fit in the MRI scanner bore
Current psychotic disorder, alcohol use disorder or drug use disorder for drugs other than cannabis (moderate or severe only, mild is allowable at PI's discretion). AUD and DUD in remission are also allowable at PI's discretion.
Pregnant, breastfeeding or planning to become pregnant during the course of the study (females)
Current enrollment in another smoking research study or having participated in a study involving daily use of Spectrum cigarettes or other reduced nicotine products within the past three months
Irregular sleep-wake cycles (e.g. swing-shift work, unusual sleep pattern)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason A Oliver, PhD
Phone
405-271-8001
Ext
14005
Email
Jason-Oliver@ouhsc.edu
Facility Information:
Facility Name
Hardesty Center for Clinical Research and Neuroscience
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashton Baltazar, M.S.
Email
Ashton-Baltazar@ouhsc.edu
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 relevant administrative offices 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
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