Low Nicotine Cigarettes, Smoking, and Chronic Pain

NCT05032755 | Completed Results

• 2 other identifiers: Pro00108705R21DA052729
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Smoking, Cigarette

Outcome Measures

Primary Outcomes (6)

• Cigarettes Smoked Per Day

  Average number of cigarettes smoked per day over the past week, as reported on timeline follow-back interview at each weekly visit

  Weekly for 5 weeks

• Weekly Measures of Cigarette Dependence as Assessed by the Fagerstrom Test of Cigarette Dependence (FTCD)

  The FTCD is a widely used 6-item measure of dependence, with total scores ranging from 0 (low dependence) to 10 (high dependence)

  Weekly for 5 weeks

• Weekly Ratings of Withdrawal Symptoms as Measured by the Minnesota Tobacco Withdrawal Scale

  The MNWS is a 7-item measure of withdrawal symptoms, with responses indicated on a likert scale ranging from 0 (none) to 4 (severe). The total score ranges from 0 to 28, with higher scores indicating greater withdrawal symptoms.

  Weekly for 5 visits

• Weekly Changes in Pain Intensity as Measured by the Past-week Version of the Brief Pain Inventory (BPI)

  The BPI is a well-validated 11-item self-report measure. Pain intensity is calculated as the average of 3 items (worst pain, least pain, and average pain). Scores are averaged with the total score ranging from 0 to 10 with higher scores indicating more pain.

  Weekly for 5 visits

• Ratings of Withdrawal Symptoms During Smoking Abstinence, as Measured by the Minnesota Tobacco Withdrawal Scale (MNWS)

  The MNWS is a 7-item measure of withdrawal symptoms, with responses indicated on a likert scale ranging from 0 (none) to 4 (severe). The total score ranges from 0 to 28, with higher scores indicating greater withdrawal symptoms.

  Baseline (pre-intervention) abstinence session (i.e., prior to week 1), follow-up abstinence session (immediately after final week of cigarette use; i.e., week 5)

• Pain Intensity During Smoking Abstinence as Measured by the Past 24-hour Version of the Brief Pain Inventory (BPI)

  The BPI is a well-validated 11-item self-report measure. Pain intensity is calculated as the average of 3 items (worst pain, least pain, and average pain). Scores are averaged with the total score ranging from 0 to 10 with higher scores indicating more pain.

  Baseline (pre-intervention) abstinence session (i.e., before week 1), follow-up abstinence session (immediately after final week of cigarette use; i.e., week 5)

Other Outcomes (7)

• Changes in Smoking to Cope With Pain as Measured by the Pain and Smoking Inventory (PSI)

  Weekly visits 1, 3, and 5

• Changes in Motivation to Quit Smoking as Measured by the Contemplation Ladder

  Weekly visits 1, 3, and 5

• Changes in Smoking Abstinence Self-efficacy as Measured by the Smoking Self-Efficacy Questionnaire (SEQ-12)

  Weekly visits 1, 3, and 5

Study Arms (2)

VLNC Group

EXPERIMENTAL

Participants in this condition will be provided with Spectrum NRC102/103 (nonmenthol/menthol) cigarettes, which have a nicotine content of approximately 0.4 mg/g tobacco with reported nicotine yield (ISO) of 0.03 +/- 0.01 mg and a tar yield of 9 +/- 1.5. Participants will be asked to smoke only study cigarettes for 4 weeks.

Other: SPECTRUM NRC 102/103 investigational cigarettes

NNC Group

ACTIVE COMPARATOR

Participants in this condition will be provided with Spectrum NRC600/601 (non-menthol/menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco with reported nicotine yield (ISO) of 0.8 +/- 0.15 mg and a tar yield of 10.5 +/- 1.5.

Other: SPECTRUM NRC 600/601 investigational cigarettes

Interventions

SPECTRUM NRC 102/103 investigational cigarettes OTHER

Very low nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes

VLNC Group

SPECTRUM NRC 600/601 investigational cigarettes OTHER

Normal nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes

NNC Group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Duke University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Chronic Pain; Cigarette Smoking

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Results Point of Contact

• Title: Maggie Sweitzer
• Organization: Duke University Medical Center

maggie.sweitzer@duke.edu

919-668-0094

Study Officials

• Maggie Sweitzer

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 2, 2021
• Study Start: June 23, 2022
• Primary Completion: July 4, 2024
• Study Completion: July 4, 2024
• Last Updated: August 29, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)