Smoking Withdrawal for Chronic Pain

(PRISM02 Trial)

Overseen By Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Opioids, others

Disqualifiers: Cancer pain, Hypertension, Seizure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how quitting smoking affects pain processing in the brain for people with chronic pain. Researchers will compare brain activity using fMRI (a type of brain scan) when participants smoke as usual versus when they abstain. The findings may help develop strategies to support individuals with chronic pain in their efforts to quit smoking. Ideal participants have experienced chronic back pain for at least six months and smoke at least 10 cigarettes a day. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new support strategies for quitting smoking.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both smoking and not smoking during an fMRI (a type of brain scan) are generally safe for participants. When people stop smoking, they might feel a stronger urge to smoke and experience withdrawal symptoms, such as increased stress or anxiety. However, these feelings are usually temporary and not harmful.

For those who continue smoking during an fMRI session, studies have found that participants tolerate the scan well, with no reports of serious side effects from the scan itself.

In summary, undergoing an fMRI while either smoking or not smoking is safe. Participants typically do not encounter any serious problems during these sessions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how smoking cessation might affect chronic pain management and brain activity. Unlike typical chronic pain treatments that often rely on medications like opioids or anti-inflammatories, this study uses functional MRI sessions to observe brain changes in response to smoking habits. By comparing the brain activity of participants during smoking and abstinent periods, the researchers aim to understand the potential link between smoking withdrawal and pain perception. This could pave the way for non-pharmacological strategies in managing chronic pain, offering hope for a more holistic approach to treatment.

What evidence suggests that this trial's treatments could be effective for smoking withdrawal in individuals with chronic pain?

Research shows that smoking can worsen chronic pain and related issues. Smokers with chronic pain often experience more intense pain, fatigue, and mood problems than non-smokers. This trial will explore how smoking and abstinence affect brain activity related to pain. Participants will undergo two fMRI sessions: one while smoking as usual and another while abstinent. Studies indicate that quitting smoking can alter how the brain processes pain. Not smoking appears to reduce pain signals in the brain and might aid in better pain management. These findings suggest that stopping smoking could be a helpful step for those dealing with chronic pain. ^{6 7 8 9 10}

Who Is on the Research Team?

Maggie Sweitzer, Ph.D.

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults aged 21-65 who smoke at least 10 cigarettes a day for more than two years. Participants must either have chronic non-cancer low back pain lasting over six months or no history of chronic pain, and own a smartphone that can run the study's software.

Inclusion Criteria

I own a smartphone that can run the EMA software.

I have had chronic low back pain for 6 months or more, or I have no history of chronic pain.

I am between 21 and 65 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 session

1 visit (in-person)

Sensory Testing and Training

Participants are introduced to the mock MRI scanner and familiarized with the thermal pain stimulation and psychophysiological rating procedures

1 session

1 visit (in-person)

fMRI Sessions

Participants 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

2 sessions

2 visits (in-person)

Baseline EMA

Participants complete 3 days of baseline ecological momentary assessment (EMA), answering questions about their pain, smoking urge, and recent smoking

3 days

Abstinence Test

Participants attempt to abstain from smoking during a 1-week test, with daily reinforcement and biochemical verification of abstinence

1 week

Daily breath samples over video

Follow-up

Participants return to the lab for a final visit to return all equipment and conclude the study

1 session

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Abstinent fMRI session
• Smoking as usual fMRI session

Trial Overview The study examines how quitting smoking affects brain processing of pain in smokers with and without chronic pain by comparing brain activity during withdrawal (abstinent fMRI session) to normal smoking conditions (smoking as usual fMRI session).

How Is the Trial Designed?

Group I: Participants without chronic pain - Smoking as usual fMRI session first followed by Abstinent fMRI Experimental Treatment 2 Interventions

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

Group II: Participants without chronic pain - Abstinent fMRI session first followed by Smoking as usual fMRI Experimental Treatment 2 Interventions

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

Group III: Participants with chronic pain - Smoking as usual fMRI session first followed by Abstinent fMRI Experimental Treatment 2 Interventions

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

Group IV: Participants with chronic pain - Abstinent fMRI session first followed by Smoking as usual fMRI Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0149763425001162

Differences in fMRI-based connectivity during abstinence ... Abstinence and Transcranial Magnetic Stimulation (TMS) both attenuated differences in connectivity between HD and HC, often by strengthening connectivity in HD.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4470394/

Reduced fMRI activity predicts relapse in patients ... Neuroimaging, behavioral, and clinical data obtained at intake were compared between patients who relapsed with those who remained abstinent, to identify which ...

3. nature.com nature.com/articles/s41598-020-79196-z

Test–retest reliability of laser evoked pain perception and ... We observed that laser-evoked pain perception was significantly declined across sessions, coupled with decreased brain responses.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6300537/

Can neuroimaging help combat the opioid epidemic? A ... Extant data therefore suggest that corticolimbic engagement to drug cues decreases with prolonged abstinence, and that individual differences in baseline reward ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/brb3.70380

Baseline Functional Connectivity of the Mesolimbic ... Forty individuals underwent fMRI followed by 8 weeks of either treatment as usual (TAU) or one of two CBT in addition to TAU: acceptance and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8047070/

Associations Between Smoking Abstinence, Inhibitory Control ... Among sated smokers, worse IC task performance and greater IC-related rIFG activity have been shown to be associated with greater relapse ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3742373/

Brain fMRI Responses to Smoking-Related Images Prior to ... These data suggest that during extended smoking abstinence, fMRI reactivity to smoking versus neutral stimuli persists in brain areas involved in attention.

8. nature.com nature.com/articles/npp2017248

ADHD, Smoking Withdrawal, and Inhibitory Control Participants then completed an fMRI training and medical safety session, which assessed tolerability of MPH effects and provided task ...

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/53/NCT03386253/Prot_SAP_000.pdf

Effect of a Non-Invasive Brain Stimulation Technique on ... Camchong and Lim have identified, using functional magnetic resonance imaging (fMRI), brain biomarkers that support long-term abstinence from ...

10. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0288544

Acute nicotine abstinence amplifies subjective withdrawal ... Abstinence increased smoking urges and withdrawal symptoms, and potentiated threat-evoked distress, but had negligible consequences for EAc threat reactivity.