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

36 Participants Needed

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

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+