Low Nicotine Cigarettes for Chronic Pain

Overseen By Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Buprenorphine

Must not be taking: Nicotine replacement

Disqualifiers: Cancer pain, Surgery, Cannabis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how switching to very low nicotine cigarettes affects cravings, withdrawal, and pain in daily smokers with chronic pain. Participants will either switch to very low nicotine cigarettes (VLNC) or continue with normal nicotine cigarettes (NNC) for four weeks. The goal is to discover if reducing nicotine can better manage pain and cravings. This trial suits adults who smoke at least 10 cigarettes a day, have chronic pain like back pain or arthritis, and are on stable treatment for opioid use disorder. As an unphased trial, it offers a unique opportunity to explore new methods for managing pain and cravings.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must be on stable buprenorphine treatment for at least 30 days before joining.

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

Research has shown that cigarettes with very low nicotine (VLNCs) are generally well-tolerated by smokers. In one study, smokers who used VLNCs for four days did not increase their smoking to compensate for the lower nicotine. Another study found that VLNCs led to better smoking-related outcomes compared to regular nicotine cigarettes (NNCs). These results suggest that VLNCs may be safer and more effective for smokers aiming to reduce their nicotine intake. Overall, these findings highlight the potential safety and benefits of using VLNCs. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using very low nicotine cigarettes (VLNCs) for chronic pain management because they offer a unique approach that could reduce nicotine dependency while potentially managing pain. Unlike standard pain treatments like opioids or NSAIDs, which often come with significant side effects or risk of addiction, VLNCs aim to maintain a smoking habit with minimal nicotine intake, possibly helping to alleviate pain without the usual health risks associated with higher nicotine levels. This novel approach could revolutionize how chronic pain is managed for smokers, offering a less harmful alternative that differentiates itself by targeting nicotine consumption directly.

What evidence suggests that this trial's treatments could be effective for chronic pain?

This trial will compare the effects of Very Low Nicotine Cigarettes (VLNC) with Normal Nicotine Cigarettes (NNC) on chronic pain. Research has shown that cigarettes with very low nicotine content can address smoking-related issues. Studies have found that people using VLNCs often feel more confident about quitting smoking and achieve better success when attempting to quit. VLNCs also reduce the urge to smoke, helping with cravings and withdrawal symptoms. Although more research is needed to understand how VLNCs directly affect pain management, early findings suggest these cigarettes might aid smokers with chronic pain by positively altering their smoking habits. ^{1 5 6 7 8}

Who Is on the Research Team?

Maggie Sweitzer, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults over 21 who smoke daily, have chronic non-cancer pain due to structural issues like back pain or arthritis, and are on stable buprenorphine treatment for opioid use. Participants must smoke at least 10 cigarettes a day, have a certain level of breath CO, own a smartphone for assessments, and be open to quitting smoking.

Inclusion Criteria

Self-report smoking at least 10 cigarettes/day

Expired breath carbon monoxide (CO) level >8 ppm

Have a smartphone capable of running software for ecological momentary assessment

Exclusion Criteria

Other significant health problems

Current disability litigation

Current daily or near-daily cannabis use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants switch to smoking either very low nicotine content (VLNC) or normal nicotine content (NNC) cigarettes for 4 weeks

4 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Normal Nicotine Cigarettes (NNC)
• Very Low Nicotine Cigarettes (VLNC)

Trial Overview The study compares the effects of switching from normal nicotine content (NNC) cigarettes to very low nicotine content (VLNC) ones on cravings, withdrawal symptoms, and pain in people with chronic pain who are undergoing office-based buprenorphine treatment and smoke regularly.

How Is the Trial Designed?

Group I: Very Low Nicotine Cigarette (VLNC) Group Experimental Treatment 1 Intervention

Participants in this condition will be provided with VLNCs and asked to switch to smoking only study cigarettes for 4 weeks.

Group II: Normal Nicotine Cigarette (NNC) Group Active Control 1 Intervention

Participants in this condition will be provided with NNCs and asked to switch to smoking only study cigarettes for 4 weeks.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3293999/

Smoking Cigarettes as a Coping Strategy for Chronic Pain is ... Patients who reported smoking as a coping strategy for chronic pain scored significantly worse compared to the other 2 groups on the majority of measures of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05032755

Low Nicotine Cigarettes, Smoking, and Chronic Pain The goal of this study is to evaluate the effects of very low nicotine content (VLNC) cigarettes on the dynamic associations between smoking, pain, and ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0376871624003168?dgcid=rss_sd_all

Associations between compliance with very low nicotine ... Compliance with VLNCs prior to quitting increased abstinence self-efficacy and predicted better quit outcomes above and beyond baseline smoking ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9328411/

Effects of Very Low Nicotine Content Cigarette use on ... Among people without psychiatric disorders who smoke, very low nicotine content (VLNC) cigarette use reduces cigarette reinforcement.

5. thelancet.com thelancet.com/journals/lanam/article/PIIS2667-193X(24)00123-6/fulltext

Reduced nicotine in cigarettes in a marketplace with ... This study demonstrates that VLNC cigarettes result in better smoking-related outcomes than NNC cigarettes, that the uptake of non-combusted ANDS is greater in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7125007/

The impact of exclusive use of very low nicotine cigarettes ... Among current smokers who exclusively used very low nicotine content cigarettes for four days, there was no significant compensatory smoking behavior.

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/55/NCT05032755/Prot_SAP_001.pdf

Using very low nicotine content cigarettes disrupt the pain- ... Tobacco smoking and chronic pain are highly comorbid conditions. Nicotine has been shown to provide mild, short-term anti-nociceptive effects, ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823300

Reduced Nicotine Cigarettes and E-Cigarettes in High ... This report of 3 randomized clinical trials investigates smoking reduction in adults with psychiatric conditions or lower educational level ...