Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT06983678

Conditions

Tobacco Use

Chronic Pain

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Smoking as usual fMRI session

Abstinent fMRI session

Study Details

Brief summary:

Individuals with chronic pain are more likely to smoke cigarettes and have more difficulty quitting smoking than the general population, in part because withdrawal from smoking can lead to temporary increases in pain. This research will examine how smoking withdrawal changes the way the brain processes pain, and whether these withdrawal-related changes interfere with the ability to stop smoking. The results of this research will provide important information that can be used to guide the development of interventions to help people with chronic pain who smoke cigarettes to quit smoking and improve their health.

Conditions

Tobacco Use

Chronic Pain

Study ID

NCT06983678

Start date

Nov 4, 2025

Status verified date

Nov, 2025

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. History of chronic non-cancer low back pain with duration ≥ 6 months OR no history of chronic pain;
2. age 21-65;
3. smoking of at least 10 cig/day for > 2 years;
4. have an iPhone or Android smartphone capable of running the EMA software

Exclusion Criteria:

1. pain complaint specifically due to cancer, rheumatoid arthritis, or complex regional pain syndrome;
2. actively taking steps to quit smoking;
3. inability to attend all required experimental sessions;
4. significant health problems, such as chronic hypertension, emphysema, seizure disorder, history of significant heart problems;
5. conditions that would make MRI scanning unsafe (e.g., metal implants, claustrophobia)
6. use of opioids within the past 90 days
7. past year alcohol or substance use disorder
8. positive urine test for illegal drugs (other than marijuana);
9. daily use of alcohol or marijuana;
10. lifetime history of psychotic disorder, or current unstable psychiatric disorder;
11. regular use of non-cigarette tobacco products or electronic cigarettes;
12. major surgery within the past 6 months or planned surgery within the timeframe of the study;
13. breath alcohol level > 0.0 (participants failing for BAL will be allowed to rescreen once);
14. recently quit smoking for > 3 days;
15. pregnancy or planning to become pregnant;
16. any factors that at the discretion of the investigators would adversely affect the participant or integrity of the study (e.g., ongoing legal action or disability claim regarding pain, uncontrolled psychiatric disorder, head/neck injury, use of certain medications)

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Participants with chronic pain - Smoking as usual fMRI session first followed by Abstinent fMRI

Participants with chronic pain randomized to complete a smoking as usual fMRI session followed by an Abstinent fMRI session.

experimental: Participants with chronic pain - Abstinent fMRI session first followed by Smoking as usual fMRI

Participants with chronic pain randomized to complete an Abstinent fMRI session followed by a smoking as usual fMRI session.

experimental: Participants without chronic pain - Smoking as usual fMRI session first followed by Abstinent fMRI

Participants without chronic pain randomized to complete a smoking as usual fMRI session followed by an Abstinent fMRI session.

experimental: Participants without chronic pain - Abstinent fMRI session first followed by Smoking as usual fMRI

Participants without chronic pain randomized to complete an Abstinent fMRI session followed by a smoking as usual fMRI session.

Interventions

Smoking as usual fMRI session

Participants in this condition will continue smoking as usual prior to the fMRI session

Abstinent fMRI session

Participants in this condition will be asked to abstain from smoking or using any other tobacco products for 24 hours prior to the fMRI session

Primary outcome measure

  • Pain intensity ratings to high heat vs neutral temperatures [ Time Frame: Measured at each fMRI session (up to 1.5 hours) ]
  • Activation of the inferior frontal gyrus (IFG) [ Time Frame: Measured at each fMRI session (up to 1.5 hours) ]
  • Resting state functional connectivity with the IFG [ Time Frame: Measured at each fMRI session (up to 1.5 hours) ]
  • Time to lapse [ Time Frame: Measured daily during the 1-week abstinence test ]
  • Daily pain ratings [ Time Frame: Measured with daily EMA prompts for 10 days ]
  • Daily withdrawal symptoms [ Time Frame: Measured with daily EMA prompts for 10 days ]
  • Fluctuations in pain ratings vs smoking urge [ Time Frame: Measured 5 times per day with random EMA prompts for 10 days ]
  • Fluctuations in pain ratings vs number of cigarettes smoked [ Time Frame: Measured 5 times per day with random EMA prompts for 10 days ]

Central Contacts and Locations

Central contacts

Clinical Research Coordinator

919-907-9955sweitzerlab@duke.edu

Locations

Duke North Pavilion

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Clinical Research Coordinator

984-209-9816sweitzerlab@duke.edu

More Information

Sponsor

Duke University

Last update posted

Nov 20, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2025-11-20.