Nicotine Withdrawal and Reward Processing

NCT05041959 | Completed

• 1 other identifier: K23DA042898
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking; Nicotine Dependence; Nicotine Withdrawal

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Smoking Abstinence

OTHER

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

Ad Lib Smoking

OTHER

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

Interventions

Smoking Abstinence OTHER

Participants will abstain from smoking for 24 hours

Smoking Abstinence

Ad Lib Smoking OTHER

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.

Ad Lib Smoking

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Oklahoma: lead
• Oklahoma State University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Hardesty Center for Clinical Research and Neuroscience

Tulsa, Oklahoma, 74136, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is a smoking abstinence manipulation. No masking is possible.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will abstain from smoking for 24 hours before one MRI scan and continue smoking as usual before the other

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: June 2, 2022
• Primary Completion: March 29, 2024
• Study Completion: April 15, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)