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

Duke University Medical Center, Durham, NC
Targeting 2 different conditionsSPECTRUM NRC 102/103 investigational cigarettes +1 moreN/ARecruitingLed by Maggie SweitzerResearch Sponsored by Duke University

VLNCPain Trial Summary

This trial will test if switching to cigarettes with very low nicotine content can help reduce cravings, withdrawal symptoms, and pain in people who smoke cigarettes daily and have chronic back pain.

Eligible Conditions
  • Chronic Pain
  • Smoking/Cigarette Smoking

VLNCPain Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have a high level of carbon monoxide in your breath.
You have had ongoing back pain for more than 3 months, as confirmed by your medical records or current healthcare provider.
You have had pain for at least 3 months with an average intensity of 4 out of 10, or the worst pain has been at least 6 out of 10 according to the Graded Chronic Pain Scale (GCPS).
You smoke at least 10 cigarettes every day for more than 2 years.

VLNCPain Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

VLNCPain 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.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,312 Previous Clinical Trials
3,388,630 Total Patients Enrolled
22 Trials studying Chronic Pain
11,071 Patients Enrolled for Chronic Pain
National Institute on Drug Abuse (NIDA)NIH
2,399 Previous Clinical Trials
2,061,030 Total Patients Enrolled
50 Trials studying Chronic Pain
62,222 Patients Enrolled for Chronic Pain
Maggie SweitzerPrincipal InvestigatorDuke University

Media Library

SPECTRUM NRC 102/103 investigational cigarettes (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05032755 — N/A
Chronic Pain Research Study Groups: VLNC Group, NNC Group
Chronic Pain Clinical Trial 2023: SPECTRUM NRC 102/103 investigational cigarettes Highlights & Side Effects. Trial Name: NCT05032755 — N/A
SPECTRUM NRC 102/103 investigational cigarettes (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05032755 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 35 and above eligible to enroll in this investigation?

"This study requires that its participants be aged 21 to 65; however, there are 33 medical trials for those younger and 396 clinical tests available for the elderly."

Answered by AI

Does this experiment offer opportunities for patient participation at the present time?

"Affirmative. Based on the information hosted by clinicaltrials.gov, this medical research began enrolling patients on June 23rd 2022 and is still seeking participants today. There is a total of 60 individuals that need to be recruited from 1 site."

Answered by AI

What is the current quantity of individuals being treated in this clinical research?

"Affirmative. The details available on clinicaltrials.gov confirm that this research endeavour, which was initially made public on June 23rd 2022, is currently recruiting participants. Approximately 60 individuals need to be recruited from a solitary health centre."

Answered by AI

Is it possible for me to register as a participant in this experiment?

"This research project is seeking 60 individuals with chronic pain between the ages of 21 and 65 to participate."

Answered by AI

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Duke University Medical Center
~11 spots leftby May 2024