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Low Nicotine Cigarettes for Chronic Pain and Smoking (VLNCPain Trial)
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly visits 1 and 5
Awards & highlights
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.
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.Check my eligibility
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.See study design
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.
VLNCPain Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with chronic back pain lasting more than 3 months.
Select...
I have been smoking 10 or more cigarettes daily for over 2 years.
Select...
I have had pain for 3 months or more, with it often being moderate to severe.
VLNCPain Trial 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
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 moreSecondary 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)
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.
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,426 Total Patients Enrolled
22 Trials studying Chronic Pain
11,073 Patients Enrolled for Chronic Pain
National Institute on Drug Abuse (NIDA)NIH
2,469 Previous Clinical Trials
2,619,349 Total Patients Enrolled
55 Trials studying Chronic Pain
82,900 Patients Enrolled for Chronic Pain
Maggie SweitzerPrincipal InvestigatorDuke University
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Eligibility Criteria:
This trial includes the following eligibility 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.I tried to quit smoking in the last month and succeeded for more than 3 days.You have recently used illegal drugs, as shown by a urine test.I have been diagnosed with chronic back pain lasting more than 3 months.I have had spine surgery in the last year or plan to during the study.Women who are pregnant.I have pain from a condition like cancer, arthritis, or CRPS.I am currently using methods to quit smoking.I cannot attend all the required sessions for the study.You are currently involved in a legal case related to a disability.I have had pain for 3 months or more, with it often being moderate to severe.I have been smoking 10 or more cigarettes daily for over 2 years.You have alcohol in your breath.You have used non-cigarette tobacco products more than 8 times in the last 30 days.You have a high level of carbon monoxide in your breath.I am currently using opioid pain relievers.You currently have a mental health condition that is not under control.You are currently trying to stop smoking.I have serious health issues.Your blood pressure is too high (systolic over 160 or diastolic over 100).I have not used Spectrum investigational cigarettes in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: VLNC Group
- Group 2: NNC Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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