Low Nicotine Cigarettes for Chronic Pain and Smoking

(VLNCPain Trial)

Overseen By Maggie Sweitzer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Opioids, Nicotine replacement

Disqualifiers: Bipolar, Psychotic disorder, others

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

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether switching to low nicotine cigarettes can help manage cravings, withdrawal, and pain in people with chronic back pain who smoke daily. Participants will be divided into two groups: one will smoke very low nicotine cigarettes (SPECTRUM NRC 102/103 investigational cigarettes), and the other will smoke normal nicotine cigarettes (SPECTRUM NRC 600/601 investigational cigarettes). Individuals with chronic back pain lasting over three months and who smoke at least 10 cigarettes a day might be a good fit. As an unphased trial, this study offers a unique opportunity to explore new ways to manage chronic back pain and smoking habits.

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 cannot participate if you are currently using opioid pain relievers or nicotine replacement therapy.

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

Research has shown that very low nicotine content (VLNC) cigarettes, such as the SPECTRUM NRC 102/103, have been studied for safety. When people smoked these VLNC cigarettes, they exhibited low nicotine levels in their bodies, suggesting reduced nicotine exposure.

For normal nicotine content (NNC) cigarettes, like the SPECTRUM NRC 600/601, the information provided has not identified specific safety concerns. However, these cigarettes contain significantly more nicotine than the VLNC ones.

The SPECTRUM VLNC cigarettes are identical to the VLN® cigarettes, which the FDA has approved for certain uses, providing some confidence in their safety. Overall, both types of cigarettes are under study to assess their effects on cravings and pain, and no major safety issues have been reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these investigational cigarettes because they offer a unique approach to managing chronic pain in smokers. Unlike traditional pain treatments that often rely on medications like opioids or NSAIDs, these low nicotine cigarettes, SPECTRUM NRC 102/103, provide a way to potentially reduce nicotine intake without completely quitting smoking. The very low nicotine content (0.4 mg/g) could help in managing withdrawal symptoms while addressing pain. On the other hand, the SPECTRUM NRC 600/601 cigarettes maintain a higher nicotine content (15.8 mg/g) but are still part of a controlled intervention. This trial explores whether adjusting nicotine levels can impact pain management, offering a fresh perspective beyond standard medication.

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

Research has shown that switching to very low nicotine content (VLNC) cigarettes, which participants in the VLNC Group of this trial will receive, can help smokers reduce cravings and withdrawal symptoms. Studies have found that smokers using VLNC cigarettes absorb less nicotine, potentially reducing their dependence. This could be particularly beneficial for individuals with chronic pain, as smoking can exacerbate pain. In contrast, participants in the NNC Group will receive normal nicotine content (NNC) cigarettes, which have higher nicotine levels and can sustain addiction. Early evidence suggests that VLNC cigarettes might be a useful tool for managing cravings and possibly improving pain for smokers with chronic pain. ^{3 6 7 8 9}

Who Is on the Research Team?

Maggie Sweitzer

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Have an iPhone or Android smartphone capable of running EMA software

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

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

Exclusion Criteria

You have been diagnosed with bipolar disorder or psychotic disorder at any point in your life.

Your heart beats too fast when you are not active.

You have had a problem with alcohol or drugs in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 session

1 visit (in-person)

Baseline Abstinence

Participants undergo a baseline abstinence session with measures of pain and withdrawal assessed after 24 hours of smoking abstinence

1 session

1 visit (in-person)

Baseline Period

Participants complete a 1-week baseline period with ecological momentary assessment (EMA) while continuing to smoke usual brand cigarettes

1 week

Daily EMA prompts

Treatment

Participants are randomly assigned to smoke either very low nicotine content (VLNC) or normal nicotine content (NNC) cigarettes for 4 weeks

4 weeks

Weekly laboratory visits

Follow-up Abstinence

Participants attend a final laboratory visit after abstaining from smoking for 24 hours to assess pain, craving, and withdrawal

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SPECTRUM NRC 102/103 investigational cigarettes
• SPECTRUM NRC 600/601 investigational cigarettes

Trial Overview 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.

How Is the Trial Designed?

Group I: VLNC Group Experimental Treatment 1 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 Group Active Control 1 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.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05032755

Low Nicotine Cigarettes, Smoking, and Chronic Pain The purpose of this study is to evaluate the effects of switching to very low nicotine content (VLNC) cigarettes versus normal nicotine content (NNC) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7297107/

Pharmacokinetic Profile of Spectrum Reduced Nicotine ... This study shows that Spectrum research cigarettes produce blood nicotine absorption in a dose-dependent manner, and therefore, are appropriate for use in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05032755?tab=results

Low Nicotine Cigarettes, Smoking, and Chronic Pain A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11190722/

Reduced nicotine in cigarettes in a marketplace with ... The aim of this study was to examine the effects of reduced-nicotine cigarettes in the context of the availability of alternative nicotine delivery systems.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06747871

Opioids, Low Nicotine Cigarettes, and Chronic Pain The purpose of this study is to evaluate the effects of switching to very low nicotine content (VLNC) cigarettes versus normal nicotine content (NNC) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05032755

Low Nicotine Cigarettes, Smoking, and Chronic Pain ... The purpose of this study is to evaluate the effects of switching to very low nicotine content (VLNC) cigarettes versus normal nicotine ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5870904/

Nicotine and Anatabine Exposure from Very Low ... Study participants exclusively smoking 0.4 mg/g Spectrum cigarettes are unlikely to have biomarker values above these levels. The data presented ...

8. stacks.cdc.gov stacks.cdc.gov/view/cdc/37538

Characterization of SPECTRUM Variable Nicotine ... To provide researchers an extensive characterization of the SPECTRUM variable nicotine research cigarettes. Methods Data on cigarette physical properties, ...

9. fda.gov fda.gov/media/135144/download

US Food and Drug Administration Tobacco Products ... VLN® King and VLN® Menthol King cigarettes are the same as the NRC102 and NRC103. SPECTRUM® VLNC research cigarettes. The VLN® cigarettes are ...