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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA060859-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
Eligible participants will complete an initial in-person screening session in which eligibility is confirmed and baseline pain and smoking measures are collected, followed by a sensory testing and training session, in which participants are introduced to the mock MRI scanner and familiarized with the thermal pain stimulation and psychophysiological rating procedures. Participants will then complete two fMRI sessions using a within-subjects, crossover design, with one scan following 24-hrs abstinence from smoking, and the other following smoking as usual. Both fMRI sessions will be identical other than the smoking instructions prior to the scan. During each scan, participants will complete experience and provide ratings to painful heat stimuli. Before and after scanning, participants will complete measures of craving, withdrawal, and current pain level. After completion of the scanning sessions, participants will return to the lab for a baseline visit prior to beginning the abstinence test. During that session, they will have software installed on their smartphone for ecological momentary assessment (EMA), and they will be trained in the procedures for biochemical verification of abstinence. They will then complete 3 days of baseline EMA, during which participants are prompted at 5 random times throughout the day, and once in the evening, to answer questions about their pain, smoking urge, and recent smoking. They will then continue EMA while attempting to abstain from smoking during the 1-week abstinence test. During the abstinence test, each day of abstinence is reinforced with money using a descending schedule. Participants will provide breath samples over video during this week using equipment provided by the lab in order to verify abstinence from smoking. At the conclusion of the study, participants will return to the lab for a final visit to return all equipment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with chronic pain - Smoking as usual fMRI session first followed by Abstinent fMRI | Experimental | Participants with chronic pain randomized to complete a smoking as usual fMRI session followed by an Abstinent fMRI session. |
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| Participants with chronic pain - Abstinent fMRI session first followed by Smoking as usual fMRI | Experimental | Participants with chronic pain randomized to complete an Abstinent fMRI session followed by a smoking as usual fMRI session. |
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| Participants without chronic pain - Smoking as usual fMRI session first followed by Abstinent fMRI | Experimental | Participants without chronic pain randomized to complete a smoking as usual fMRI session followed by an Abstinent fMRI session. |
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| Participants without chronic pain - Abstinent fMRI session first followed by Smoking as usual fMRI | Experimental | Participants without chronic pain randomized to complete an Abstinent fMRI session followed by a smoking as usual fMRI session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoking as usual fMRI session | Behavioral | Participants in this condition will continue smoking as usual prior to the fMRI session |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity ratings to high heat vs neutral temperatures | Participants will rate their current pain intensity following each of the heat stimulus blocks during the fMRI scans. Pain intensity is measured on a 0-10 visual analogue scale, with higher scores indicating greater pain. | Measured at each fMRI session (up to 1.5 hours) |
| Activation of the inferior frontal gyrus (IFG) | % signal change in response to the contrast of high heat vs rest will be extracted from right and left IFG | Measured at each fMRI session (up to 1.5 hours) |
| Resting state functional connectivity with the IFG | Fisher-Z transformed correlation maps of connectivity with the IFG will be evaluated within a subcortical mask including the caudate and thalamus | Measured at each fMRI session (up to 1.5 hours) |
| Time to lapse | The number of days of continuous, biochemically verified abstinence prior to smoking | Measured daily during the 1-week abstinence test |
| Daily pain ratings | Mean pain ratings during the initial days of abstinence will be examined as a function of chronic pain status, assessed at baseline | Measured with daily EMA prompts for 10 days |
| Daily withdrawal symptoms | Daily withdrawal symptoms will be assessed over EMA using the Minnesota Smoking Withdrawal Scale. Mean withdrawal symptoms during the initial days of abstinence will be examined as a function of chronic pain status, assessed at baseline | Measured with daily EMA prompts for 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | Contact | 919-907-9955 | sweitzerlab@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Maggie Sweitzer, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke North Pavilion | Recruiting | Durham | North Carolina | 27705 | United States |
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| Abstinent fMRI session | Behavioral | 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 |
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| Fluctuations in pain ratings vs smoking urge | Fluctuations in pain ratings will be examined to determine their association with level of smoking urge | Measured 5 times per day with random EMA prompts for 10 days |
| Fluctuations in pain ratings vs number of cigarettes smoked | Fluctuations in pain ratings will be examined to determine their association with number of cigarettes smoked between each assessment. | Measured 5 times per day with random EMA prompts for 10 days |
| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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