Low Nicotine Cigarettes, Smoking, and Chronic Pain
CompletedNot applicableNCT05032755
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Using Very Low Nicotine Cigarettes to Disrupt the Pain-smoking Reinforcement Cycle
- Conditions
- Chronic Pain
- Smoking, Cigarette
- Interventions
- Other: SPECTRUM NRC 102/103 investigational cigarettes
- Other: SPECTRUM NRC 600/601 investigational cigarettes
- Sponsor
- Duke University
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Start date
- 2022-06-23
- Primary completion
- 2024-07-04
- Sex
- All
- Age range
- from 21 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05032755