What side effects are associated with this type of intervention?

Common treatments for chronic pain that involve smoking cessation aids include varenicline, bupropion, and nicotine replacement therapy (NRT). Varenicline can cause nausea, vomiting, and neuropsychiatric symptoms such as anxiety and depression. Bupropion may lead to insomnia, dry mouth, and an increased risk of seizures. Nicotine replacement therapies, such as patches or nasal sprays, often result in local irritation, such as skin reactions or nasal discomfort. These treatments are generally considered safe but should be used under medical supervision, especially in patients with underlying mental health conditions.

What prior FDA approvals exist?

FDA-approved treatments for chronic pain include a variety of pharmacological options such as opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), anticonvulsants, and antidepressants. For smoking cessation, which can indirectly affect chronic pain management, the FDA has approved medications like varenicline and nicotine replacement therapies (NRTs). These treatments aim to reduce nicotine intake and manage withdrawal symptoms, similar to the approach of using VLNC cigarettes to reduce nicotine dependence and potentially alleviate chronic pain.

What other types of research exist?

Promising alternatives to VLNC cigarettes for chronic pain patients in 2024 include digital smoking cessation interventions (e.g., mobile apps, social media platforms), pharmacologic treatments like cannabinoids, non-opioid analgesics, and non-pharmacologic interventions such as mindfulness, exercise, and behavioral therapy.

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Other

Low Nicotine Cigarettes for Chronic Pain and Smoking (VLNCPain Trial)

N/A

Waitlist Available

Led By Maggie Sweitzer

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of non-cancer chronic (>3 months) back pain (confirmed in medical record or by current provider)

Smoking at least 10 cigarettes per day for > 2 years

Must not have

Quit attempt in the past 30 days resulting in > 3 days abstinence

Spine surgery within the past year or planned surgery within the timeframe of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weekly visits 1 and 5

Awards & highlights

Summary

This trial is testing cigarettes with reduced nicotine on daily smokers with chronic back pain. The goal is to see if these cigarettes can help with pain management.

Who is the study for?

This trial is for daily smokers with chronic back pain, smoking at least 10 cigarettes a day for over two years. Participants must have moderate to severe pain and own a smartphone. Excluded are those with serious health issues, recent quit attempts, pending disability litigation, certain psychiatric disorders or surgeries, high blood pressure or heart rate, opioid use, pregnancy, active quitting efforts or illegal drug use.

What is being tested?

The study tests the impact of switching from normal nicotine content (NNC) cigarettes to very low nicotine content (VLNC) ones on cravings, withdrawal symptoms and pain in individuals who smoke daily and suffer from chronic back pain.

What are the potential side effects?

While specific side effects aren't listed for VLNC cigarettes compared to NNC ones in this context; generally changing nicotine intake can affect mood swings, appetite changes, headaches and may alter pain perception.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with chronic back pain lasting more than 3 months.

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I have been smoking 10 or more cigarettes daily for over 2 years.

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I have had pain for 3 months or more, with it often being moderate to severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I tried to quit smoking in the last month and succeeded for more than 3 days.

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I have had spine surgery in the last year or plan to during the study.

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I have pain from a condition like cancer, arthritis, or CRPS.

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I cannot attend all the required sessions for the study.

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I am currently using opioid pain relievers.

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I have not used Spectrum investigational cigarettes in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly visits 1 and 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weekly visits 1 and 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly visits 1 and 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD)

Changes in abstinence-induced cigarette withdrawal as measured by the Minnesota Tobacco Withdrawal Scale (MNWS)

Changes in abstinence-induced craving as measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)

+4 more

Secondary study objectives

Changes in motivation to quit smoking as measured by the Contemplation Ladder

Changes in smoking abstinence self-efficacy as measured by the Smoking Self-Efficacy Questionnaire (SEQ-12)

Changes in smoking to cope with pain as measured by the Pain and Smoking Inventory (PSI)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VLNC GroupExperimental Treatment1 Intervention

Participants in this condition will be provided with Spectrum NRC102/103 (nonmenthol/menthol) cigarettes, which have a nicotine content of approximately 0.4 mg/g tobacco with reported nicotine yield (ISO) of 0.03 +/- 0.01 mg and a tar yield of 9 +/- 1.5. Participants will be asked to smoke only study cigarettes for 4 weeks.

Group II: NNC GroupActive Control1 Intervention

Participants in this condition will be provided with Spectrum NRC600/601 (non-menthol/menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco with reported nicotine yield (ISO) of 0.8 +/- 0.15 mg and a tar yield of 10.5 +/- 1.5.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Chronic pain treatments work through various mechanisms to alleviate pain and improve quality of life. Pharmacologic treatments like NSAIDs reduce inflammation, opioids bind to opioid receptors to block pain signals, and cannabinoids interact with cannabinoid receptors to modulate pain. Non-pharmacologic approaches such as cognitive behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR) help patients manage pain perception and develop coping strategies. The study of Very Low Nicotine Content (VLNC) cigarettes is significant as reducing nicotine intake may decrease nicotine-induced pain sensitization and withdrawal symptoms, potentially offering a novel approach to managing chronic pain and improving overall health outcomes.

Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.