SPECTRUM NRC 102/103 investigational cigarettes for Chronic Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Duke University Medical Center, Durham, NC
Chronic Pain+1 More
SPECTRUM NRC 102/103 investigational cigarettes - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether switching to very low nicotine content cigarettes might help people quit smoking.

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Eligible Conditions

  • Chronic Pain
  • Smoking, Cigarette

Treatment Effectiveness

Study Objectives

This trial is evaluating whether SPECTRUM NRC 102/103 investigational cigarettes will improve 7 primary outcomes and 3 secondary outcomes in patients with Chronic Pain. Measurement will happen over the course of Baseline, weekly for 5 weeks.

Week 4
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)
Week 5
Change in dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD)
Weekly for 5 visits
Weekly changes in craving as measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)
Weekly changes in pain intensity and interference as measured by the past-week version of the Brief Pain Inventory (BPI)
Weekly changes in withdrawal symptoms as measured by the Minnesota Tobacco Withdrawal Scale
Weekly visits 1 and 5
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)
Week 4
Changes in pain intensity and interference during smoking abstinence as measured by the past 24-hour version of the Brief Pain Inventory (BPI)

Trial Safety

Trial Design

2 Treatment Groups

NNC Group
1 of 2
VLNC Group
1 of 2
Active Control
Experimental Treatment

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. SPECTRUM NRC 102/103 Investigational Cigarettes is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

VLNC Group
Other
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.
NNC Group
Other
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weekly visits 1 and 5
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly weekly visits 1 and 5 for reporting.

Closest Location

Duke University Medical Center - Durham, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You have non-cancer chronic back pain. show original
You have had pain for at least 3 months with an average intensity of 4/10 or more on the GCPS. show original
smoking at least 10 cigarettes per day for > 2 years;
expired breath CO concentration > 10 ppm;
have an iPhone or Android smartphone capable of running EMA software

Patient Q&A Section

What are the signs of chronic pain?

"For patients presenting with chronic pain, there is no one single sign to rule in or out chronic pain. Rather, a combination of clinical signs is necessary to support the existence that the patient has chronic pain." - Anonymous Online Contributor

Unverified Answer

What causes chronic pain?

"Different types of pain are likely to have different causes, including genetics, CNS dysfunction, neuroactive chemicals or the immune system, but there is no consistent evidence to confirm any explanation." - Anonymous Online Contributor

Unverified Answer

How many people get chronic pain a year in the United States?

"Chronic pain is very common. About 30 million American adults have chronic pain, accounting for half of visits to the doctor and up to a third of disability." - Anonymous Online Contributor

Unverified Answer

Can chronic pain be cured?

"There is considerable evidence that [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) remains largely a disease of unknown cause, for which no cure can currently be demonstrated. The pain is the main motive for seeking healthcare and it persists for a number of reasons." - Anonymous Online Contributor

Unverified Answer

What are common treatments for chronic pain?

"The treatment of chronic pain is highly varied. A greater focus on prevention and treating chronic pain should be the goal of care for the affected individual." - Anonymous Online Contributor

Unverified Answer

What is chronic pain?

"Chronic pain affects around 10% of the adult population, most commonly affecting the back, neck, and shoulders. Pain is mostly experienced in people aged between 55 and 65." - Anonymous Online Contributor

Unverified Answer

How does spectrum nrc 102/103 investigational cigarettes work?

"The C-SCID regimen for nicotine inhalation is effective and well tolerated by patients with a wide variety of chronic non-malignant diseases. Results from a recent paper highlight the utility of this approach in smokers who do not respond to alternative approaches." - Anonymous Online Contributor

Unverified Answer

How serious can chronic pain be?

"Chronic pain is very serious in terms of the long-term prognosis or the functional impact. In the case of chronic pain, only timely and comprehensive management can preserve the quality of life of patients, minimize their disability and, finally, the cost of healthcare care and of institutionalization." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of spectrum nrc 102/103 investigational cigarettes?

"NRC 102 and NRC 103 products were not associated with excessive smoking-like side effects compared with the corresponding commercialized products, such as aldehydes, acetone, ethyl acetate, ketones and a variety of phthalates and toluenes, in addition to naphthalene. This profile is consistent with the high toxicity of the constituent chemicals." - Anonymous Online Contributor

Unverified Answer

Is spectrum nrc 102/103 investigational cigarettes safe for people?

"RCTs have demonstrated the safety and efficacy of SNCI. The current findings suggest that SNCI may be at increased risk of adverse events when used by a population with a higher age and greater likelihood of smoking, and a lower willingness to quit cigarettes compared with individuals at lower risk for long-term smoking cessation." - Anonymous Online Contributor

Unverified Answer

What is spectrum nrc 102/103 investigational cigarettes?

"The use of NDC 102 / NDC 103 investigational cigarettes appears to be no different from commercially available NDCs in regard to potency and nicotine content, and therefore does not appear a credible health claim. However, there is no doubt that NDC 102 / NDC 103 offer clinicians and researchers a much greater choice in terms of cigarette formats and nicotine contents, which is also a significant research and educational advantage. The use of NDC 102 / NDC 103 investigational cigarettes should widen the scope of NDC evaluation and research." - Anonymous Online Contributor

Unverified Answer

What does spectrum nrc 102/103 investigational cigarettes usually treat?

"In a recent study, findings of this study suggest that NDs with a low RYO tobacco content could be effective and acceptable in treating patients with various forms of CP (NHP), while patients with moderate or severe pain may benefit the most from NDs containing a high RYO tobacco content." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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