Low Nicotine Cigarettes for Chronic Pain

Overseen By Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Buprenorphine

Must not be taking: Nicotine replacement

Disqualifiers: Cancer pain, Surgery, Cannabis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effects of switching to very low nicotine content (VLNC) cigarettes versus normal nicotine content (NNC) cigarettes on craving, withdrawal, and pain among individuals with chronic pain who smoke cigarettes daily and are attending office-based buprenorphine treatment (OBBT).

Research Team

Maggie Sweitzer, PhD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for adults over 21 who smoke daily, have chronic non-cancer pain due to structural issues like back pain or arthritis, and are on stable buprenorphine treatment for opioid use. Participants must smoke at least 10 cigarettes a day, have a certain level of breath CO, own a smartphone for assessments, and be open to quitting smoking.

Inclusion Criteria

Self-report smoking at least 10 cigarettes/day

Expired breath carbon monoxide (CO) level >8 ppm

Have a smartphone capable of running software for ecological momentary assessment

Exclusion Criteria

Other significant health problems

Current disability litigation

Current daily or near-daily cannabis use

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants switch to smoking either very low nicotine content (VLNC) or normal nicotine content (NNC) cigarettes for 4 weeks

4 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Normal Nicotine Cigarettes (NNC)
• Very Low Nicotine Cigarettes (VLNC)

Trial Overview The study compares the effects of switching from normal nicotine content (NNC) cigarettes to very low nicotine content (VLNC) ones on cravings, withdrawal symptoms, and pain in people with chronic pain who are undergoing office-based buprenorphine treatment and smoke regularly.

Participant Groups

Group I: Very Low Nicotine Cigarette (VLNC) Group Experimental Treatment 1 Intervention

Participants in this condition will be provided with VLNCs and asked to switch to smoking only study cigarettes for 4 weeks.

Group II: Normal Nicotine Cigarette (NNC) Group Active Control 1 Intervention

Participants in this condition will be provided with NNCs and asked to switch to smoking only study cigarettes for 4 weeks.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+