Can Ultra-Low nicotine smokes help break the habit for those in pain?

NCT ID NCT06747871

Disease control Sponsor: Duke University Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether switching to very low nicotine cigarettes can reduce cravings, withdrawal, and pain in people who smoke daily, have chronic pain, and are on buprenorphine for opioid use disorder. Sixty participants will be randomly assigned to either very low nicotine or normal nicotine cigarettes for several weeks. Researchers will measure changes in smoking behavior, pain levels, and withdrawal symptoms to see if this approach could support quitting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Very low nicotine cigarettes (VLNC) vs. normal nicotine cigarettes (NNC)
What this could lead to: If it works, this could point toward a safer way to help people with chronic pain and opioid use disorder reduce or quit smoking.
What could go wrong: This is a small, early-phase study (60 people) that only looks at short-term effects. It may not lead to a proven cessation method, and switching to very low nicotine cigarettes might not reduce cravings or pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome nicotine dependence opiate dependence Tobacco Use

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic pain Opioid substitution treatment Tobacco use

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can Ultra-Low nicotine smokes help break the habit for those in pain?

What the study statuses mean