Chronic PainNCT06747871
Opioids, Low Nicotine Cigarettes, and Chronic Pain
A study testing Very Low Nicotine Cigarettes (VLNC) and Normal Nicotine Cigarettes (NNC) in people with Chronic Pain and Tobacco Use, run by Duke University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Pain, Tobacco Use, Opioid Substitution Treatment
- What is being tested?
- Very Low Nicotine Cigarettes (VLNC) and Normal Nicotine Cigarettes (NNC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2025to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
North Pavilion
Durham, North Carolina, 27705
Clinical Research Coordinator, 919-907-9955, sweitzerlab@duke.edu
About this study
Official title: Targeting Reinforcement Mechanisms for Smoking Cessation Using Very Low Nicotine Content Cigarettes in Individuals With Opioid Use Disorder and Chronic Pain
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).
- Conditions
- Chronic Pain, Tobacco Use, Opioid Substitution Treatment
- Being tested
- Very Low Nicotine Cigarettes (VLNC), Normal Nicotine Cigarettes (NNC)
- Medical subject headings
- Chronic Pain, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very Low Nicotine Cigarettes (VLNC)Behavioural
Spectrum NRC 102/103 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 0.4 mg/g tobacco.
Normal Nicotine Cigarettes (NNC)Behavioural
Spectrum NRC 600/601 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco.
| Study group | Role | What they receive |
|---|---|---|
| Very Low Nicotine Cigarette (VLNC) Group | Experimental | Participants in this condition will be provided with VLNCs and asked to switch to smoking only study cigarettes for 4 weeks. Receives: Behavioral: Very Low Nicotine Cigarettes (VLNC) |
| Normal Nicotine Cigarette (NNC) Group | Active comparator | Participants in this condition will be provided with NNCs and asked to switch to smoking only study cigarettes for 4 weeks. Receives: Behavioral: Normal Nicotine Cigarettes (NNC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine Dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD)
The FTCD has a total score of 0 to 10, where a greater score indicates a greater physical dependence on nicotine.
Measured: Baseline and weekly during study cigarette use (4 weeks)
Cigarettes per Day
Average cigarettes smoked per day during the past week will be calculated using timeline follow-back methods
Measured: Baseline and weekly during study cigarette use (4 weeks)
Pain as measured by the Brief Pain Inventory (BPI)
The BPI has an averaged score of 0 to 10, where a greater score indicates greater pain.
Measured: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
Mechanical Hyperalgesia
Mechanical hyperalgesia is a condition that causes increased sensitivity to mechanical stimuli after an injury to the skin. Discriminability and response bias will be assessed using a computerized pressure algometer.
Measured: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions
Smoking Withdrawal as measured by the Minnesota Withdrawal Scale (MNWS)
The MNWS has a total score range of 0 to 68, where a higher score indicates greater symptoms of withdrawal.
Measured: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
Cigarette Craving as measured by the Questionnaire of Smoking Urges-Brief (QSU-B)
The QSU-B has a total score range of 0 to 100, where a higher score indicates greater craving.
Measured: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
Cigarette Purchase Task - demand intensity
Outcomes for the cigarette purchase task will include demand intensity (i.e., consumption at $0) and Omax (i.e., max expenditure at any price point).
Measured: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions
Cigarette Purchase Task - Omax
Outcomes for the cigarette purchase task will include demand intensity (i.e., consumption at $0) and Omax (i.e., max expenditure at any price point).
Measured: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions
Pain-Smoking Associations as measured by Ecological Momentary Assessment (EMA)
EMA (also called experience sampling or daily diary method) involves repeated sampling of people's current experiences (e.g. pain) in real time in their natural environments.
Measured: Baseline, weeks 1 and 4 of study cigarette use
Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - smoking frequency
Within-person variability in smoking frequency assessed via EMA before and after buprenorphine administration.
Measured: Baseline, weeks 1 and 4 of study cigarette use
Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - craving
Within-person variability in smoking craving assessed via EMA before and after buprenorphine administration.
Measured: Baseline, weeks 1 and 4 of study cigarette use
Opioid Withdrawal as measured by the Short Opioid Withdrawal Scale (SOWS)
The SOWS consists of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0-not at all, 1-a little, 2-moderately, 3-quite a bit, 4-extremely. The total score ranges from 0 to 64, where a higher score indicates greater symptoms of withdrawal.
Measured: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
Secondary outcomes (4)
Number of participants willing to Quit Smoking
Decision (yes/no) to engage in the optional quit attempt
Measured: post-intervention, after 24 hrs abstinence
Smoking abstinence self-efficacy as measured by the Self-Efficacy Questionnaire (SEQ)
The SEQ has a total score range of 10 to 40, where a higher score indicates greater self-efficacy.
Measured: Weekly visits 1 and 5
Pain and Smoking Inventory (PSI)
The PSI total score is computed by averaging scores across the nine items. Items are endorsed on a seven-point Likert scale anchored at 0 (not true at all), 3 (somewhat true), and 6 (extremely true). Scores range from 0 to 6, where higher scores indicate greater perceptions that pain and smoking are interrelated.
Measured: Weekly visits 1 and 5
Barriers to Quitting Smoking in Substance Abuse Treatment (BSQ-SAT)
The BQS-SAT is an 11-item true-false instrument of perceived barriers to quitting smoking plus one open-ended item. The score can range from 0 to 4.86, where a higher score indicates a greater perceived barrier.
Measured: Weekly visits 1 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start15 Apr 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Maggie Sweitzer, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747871
- Sponsor's protocol ID
- Pro00116478
- Other IDs
- 1R34DA060477-01A1
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final dataset will include demographic, interview and self-report data. The investigators will share de-identified individual-participant level (IPD) data. Appropriate measures will be used for data de-identification and sharing, and informed consent will reflect those plans.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Reinforcement Mechanisms for Smoking Cessation Using Very Low Nicotine Content Cigarettes in Individuals With Opioid Use Disorder and Chronic Pain
- ClinicalTrials.gov ID
- NCT06747871
- Acronym / sponsor ID
- Pro00116478
- Conditions
- Chronic Pain, Tobacco Use, Opioid Substitution Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very Low Nicotine Cigarette (VLNC) Group | Experimental | Behavioral: Very Low Nicotine Cigarettes (VLNC)Participants in this condition will be provided with VLNCs and asked to switch to smoking only study cigarettes for 4 weeks. |
| Normal Nicotine Cigarette (NNC) Group | Active comparator | Behavioral: Normal Nicotine Cigarettes (NNC)Participants in this condition will be provided with NNCs and asked to switch to smoking only study cigarettes for 4 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very Low Nicotine Cigarettes (VLNC)Spectrum NRC 102/103 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 0.4 mg/g tobacco. | Behavioural | Very Low Nicotine Cigarette (VLNC) Group |
| Normal Nicotine Cigarettes (NNC)Spectrum NRC 600/601 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco. | Behavioural | Normal Nicotine Cigarette (NNC) Group |
Primary outcome
Nicotine Dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD)
Time frame: Baseline and weekly during study cigarette use (4 weeks)
The FTCD has a total score of 0 to 10, where a greater score indicates a greater physical dependence on nicotine.
Cigarettes per Day
Time frame: Baseline and weekly during study cigarette use (4 weeks)
Average cigarettes smoked per day during the past week will be calculated using timeline follow-back methods
Pain as measured by the Brief Pain Inventory (BPI)
Time frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
The BPI has an averaged score of 0 to 10, where a greater score indicates greater pain.
Mechanical Hyperalgesia
Time frame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions
Mechanical hyperalgesia is a condition that causes increased sensitivity to mechanical stimuli after an injury to the skin. Discriminability and response bias will be assessed using a computerized pressure algometer.
Smoking Withdrawal as measured by the Minnesota Withdrawal Scale (MNWS)
Time frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
The MNWS has a total score range of 0 to 68, where a higher score indicates greater symptoms of withdrawal.
Cigarette Craving as measured by the Questionnaire of Smoking Urges-Brief (QSU-B)
Time frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
The QSU-B has a total score range of 0 to 100, where a higher score indicates greater craving.
Cigarette Purchase Task - demand intensity
Time frame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions
Outcomes for the cigarette purchase task will include demand intensity (i.e., consumption at $0) and Omax (i.e., max expenditure at any price point).
Cigarette Purchase Task - Omax
Time frame: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions
Outcomes for the cigarette purchase task will include demand intensity (i.e., consumption at $0) and Omax (i.e., max expenditure at any price point).
Pain-Smoking Associations as measured by Ecological Momentary Assessment (EMA)
Time frame: Baseline, weeks 1 and 4 of study cigarette use
EMA (also called experience sampling or daily diary method) involves repeated sampling of people's current experiences (e.g. pain) in real time in their natural environments.
Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - smoking frequency
Time frame: Baseline, weeks 1 and 4 of study cigarette use
Within-person variability in smoking frequency assessed via EMA before and after buprenorphine administration.
Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - craving
Time frame: Baseline, weeks 1 and 4 of study cigarette use
Within-person variability in smoking craving assessed via EMA before and after buprenorphine administration.
Opioid Withdrawal as measured by the Short Opioid Withdrawal Scale (SOWS)
Time frame: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
The SOWS consists of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0-not at all, 1-a little, 2-moderately, 3-quite a bit, 4-extremely. The total score ranges from 0 to 64, where a higher score indicates greater symptoms of withdrawal.
4 secondary outcomes
Number of participants willing to Quit Smoking
Time frame: post-intervention, after 24 hrs abstinence
Smoking abstinence self-efficacy as measured by the Self-Efficacy Questionnaire (SEQ)
Time frame: Weekly visits 1 and 5
Pain and Smoking Inventory (PSI)
Time frame: Weekly visits 1 and 5
Barriers to Quitting Smoking in Substance Abuse Treatment (BSQ-SAT)
Time frame: Weekly visits 1 and 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Yes. The final dataset will include demographic, interview and self-report data. The investigators will share de-identified individual-participant level (IPD) data. Appropriate measures will be used for data de-identification and sharing, and informed consent will reflect those plans.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maggie Sweitzer, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very Low Nicotine Cigarettes (VLNC) and Normal Nicotine Cigarettes (NNC) in people with Chronic Pain and Tobacco Use, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator (919-907-9955, ta141@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nicotine Dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD) (time frame: Baseline and weekly during study cigarette use (4 weeks)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.