N/A
N=35
Low Nicotine Cigarettes, Smoking, and Chronic Pain
Chronic Pain · Smoking, Cigarette
Bottom Line
View on ClinicalTrials.gov: NCT05032755 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Cigarettes Smoked Per Day — 14.5; 17.2; 16.4; 20.3 cigarettes/day — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SPECTRUM NRC 102/103 investigational cigarettes (Other); SPECTRUM NRC 600/601 investigational cigarettes (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cigarettes Smoked Per Day |
14.5; 17.2; 16.4; 20.3; 13.5; 23.4 | <.0001 sig |
| PRIMARY Weekly Measures of Cigarette Dependence as Assessed by the Fagerstrom Test of Cigarette Dependence (FTCD) |
4.95; 5.56; 4.32; 5.88; 4.11; 6.19 | <.0001 sig |
| PRIMARY Weekly Ratings of Withdrawal Symptoms as Measured by the Minnesota Tobacco Withdrawal Scale |
12.05; 10.69; 12.42; 10.38; 12.32; 12.38 | 0.065 |
| PRIMARY Weekly Changes in Pain Intensity as Measured by the Past-week Version of the Brief Pain Inventory (BPI) |
5.1; 4.04; 4.97; 3.88; 4.61; 4.23 | 0.007 sig |
| PRIMARY Ratings of Withdrawal Symptoms During Smoking Abstinence, as Measured by the Minnesota Tobacco Withdrawal Scale (MNWS) |
13.2; 14.4; 8.63; 11.6 | 0.325 |
| PRIMARY Pain Intensity During Smoking Abstinence as Measured by the Past 24-hour Version of the Brief Pain Inventory (BPI) |
4.53; 3.83; 3.51; 2.85 | — |
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 experiences with craving, withdrawal, and pain among individuals with chronic back pain who smoke cigarettes daily.
Eligibility Criteria
Inclusion Criteria
- diagnosis of non-cancer chronic (>3 months) back pain (confirmed in medical record or by current provider);
- Pain duration of >=3 months with an average intensity of >/= 4/10 or worst pain >/=6/10 as assessed by Graded Chronic Pain Scale (GCPS);
- smoking at least 10 cigarettes per day for > 2 years;
- expired breath CO concentration > 10 ppm;
- have an iPhone or Android smartphone capable of running EMA software
Exclusion Criteria
- actively taking steps to quit smoking;
- inability to attend all required experimental sessions;
- report of significant health problems;
- systolic blood pressure > 160 or diastolic blood pressure > 100;
- resting heart rate > 100;
- breath alcohol level > 0.0;
- current use of opioid pain relievers;
- lifetime history of bipolar or psychotic disorder;
- current unstable psychiatric disorder as assessed by the MINI;
- use of non-cigarette tobacco products > 8 times in the past 30 days;
- current use of nicotine replacement therapy (NRT) or other smoking cessation strategy;
- use of Spectrum investigational cigarettes in the past year;
- quit attempt in the past 30 days resulting in > 3 days abstinence;
- past year alcohol or substance use disorder;
- use of illegal drugs as measured by urine drug screen;
- pain complaint due to specific medical conditions (e.g., cancer, rheumatoid arthritis, complex regional pain syndrome);
- spine surgery within the past year or planned surgery within the timeframe of the study;
- current disability litigation pending;
- positive pregnancy test among women
Data sourced from ClinicalTrials.gov (NCT05032755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.