Opioids, Low Nicotine Cigarettes, and Chronic Pain

Duke University

Status: Enrolling

Conditions: Opioid Substitution Treatment; Chronic Pain; Tobacco Use

Treatments: Behavioral: Very Low Nicotine Cigarettes (VLNC); Behavioral: Normal Nicotine Cigarettes (NNC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06747871

Pro00116478

1R34DA060477-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 21+ years who smoke cigarettes daily
• Chronic non-cancer musculoskeletal pain secondary to structural changes (e.g., low back pain, osteoarthritis)
• Have received stable office-based buprenorphine treatment for opioid use disorder for at least 30 days
• 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
• Open to exploring the possibility of quitting smoking

Exclusion criteria

• Pain specifically due to cancer
• Other significant health problems
• Major surgery within the past 6 months or planned surgery within the timeframe of the study
• Current disability litigation
• Use of electronic cigarettes or other non-cigarette tobacco products > 9 of the past 30 days
• Current use of nicotine replacement therapy or other cessation treatment
• Current daily or near-daily cannabis use
• History of psychotic disorder
• Acute suicidality or current unstable psychiatric disorder
• Positive pregnancy test
• Actively seeking smoking cessation treatment

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Very Low Nicotine Cigarette (VLNC) Group

Experimental group

Description:

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

Treatment:

Behavioral: Very Low Nicotine Cigarettes (VLNC)

Normal Nicotine Cigarette (NNC) Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Normal Nicotine Cigarettes (NNC)