Low Nicotine Cigarettes for Chronic Pain and Smoking
(VLNCPain Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Abstinence
Participants undergo a baseline abstinence session with measures of pain and withdrawal assessed after 24 hours of smoking abstinence
Baseline Period
Participants complete a 1-week baseline period with ecological momentary assessment (EMA) while continuing to smoke usual brand cigarettes
Treatment
Participants are randomly assigned to smoke either very low nicotine content (VLNC) or normal nicotine content (NNC) cigarettes for 4 weeks
Follow-up Abstinence
Participants attend a final laboratory visit after abstaining from smoking for 24 hours to assess pain, craving, and withdrawal
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SPECTRUM NRC 102/103 investigational cigarettes
- SPECTRUM NRC 600/601 investigational cigarettes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator