Nicotine Withdrawal and Reward Processing (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: Completed
• Conditions: Nicotine Dependence; Cigarette Smoking; Nicotine Withdrawal
• Intervention / Treatment: Other: Smoking Abstinence; Other: Ad Lib Smoking

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Hardesty Center for Clinical Research and Neuroscience

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Generally healthy
2. Age 21-55
3. Right-handed using a three-item scale
4. Daily smoker of ≥ 6 cigarettes/day
5. Smoking regularly for ≥ 1 year
6. Have a smartphone capable of running the MetricWire application
7. Able to read and understand English
8. Able to identify at least 6 pleasurable activities they do not do concurrently with smoking or associate with smoking.
9. Able to identify at least 6 unique locations/scenarios they do associate with smoking

Exclusion Criteria:

1. Planning to quit smoking within the next 60 days
2. Currently seeking or receiving treatment for smoking cessation
3. Use of smokeless tobacco, nicotine replacement products or electronic cigarettes more than 5 days in the past month.
4. Breath alcohol level ≥.001. Participants may be allowed one reschedule at the discretion of the PI or other study staff.

5. Positive toxicology screen for illicit drugs

   1. Marijuana will be tested for but will not be exclusionary
   2. Participants failing the toxicology screen may be allowed one re-screening attempt at the PI's discretion
   3. 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
6. Current use of antipsychotic or stimulant medications.

7. Significant health problems or those that would impact scientific goals of the project, including (but not limited to):

   1. Cancer, Bronchitis, Emphysema, COPD
   2. Asthma or Breathing Problems
   3. Insulin-Dependent Diabetes
   4. Heart disease, angina, heart failure, serious arrhythmia or heart attack within the past 6 months
   5. Systolic Blood Pressure > 160, Diastolic Blood Pressure > 100, HR > 115 bpm (one re-screen allowed).
   6. Glaucoma, color blindness or an uncorrected vision problem
   7. Significant hearing loss requiring the use of hearing aids or other hearing problems that would impact
   8. History of stroke, brain tumor, seizure disorder, or traumatic brain injury
   9. Metal implants (e.g. pacemaker, surgical pins, certain dental repairs), dental braces, or metal fragment injuries.
   10. Claustrophobia
   11. Weight > 350 pounds or unable to fit in the MRI scanner bore
   12. 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.
   13. Pregnant, breastfeeding or planning to become pregnant during the course of the study (females)
8. 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
9. Irregular sleep-wake cycles (e.g. swing-shift work, unusual sleep pattern)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

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) in the day leading up to the scan 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 2-4 weeks
Ecological Momentary Assessment (EMA) Pleasure Ratings	Anticipated and experienced pleasure based on self-report ratings acquired each day during the EMA phase	2-4 weeks

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: National Institute on Drug Abuse (NIDA); Oklahoma State University

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Actual): March 29, 2024
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Substance Withdrawal Syndrome
• Other Study ID Numbers: K23DA042898 (U.S. NIH Grant/Contract)

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 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.
• 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