Low Nicotine Cigarettes, Smoking, and Chronic Pain (VLNCPain)

• ClinicalTrials.gov Identifier: NCT05032755
• Recruitment Status: Recruiting
• First Posted: September 2, 2021
• Last Update Posted: July 26, 2022
• Sponsor: Duke University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Duke University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain; Smoking, Cigarette	Other: SPECTRUM NRC 102/103 investigational cigarettes; Other: SPECTRUM NRC 600/601 investigational cigarettes	Not Applicable

Detailed Description:

The goal of this study is to evaluate the effects of very low nicotine content (VLNC) cigarettes on the dynamic associations between smoking, pain, and withdrawal among daily smokers with chronic (> 3 months) non-cancer back pain (n=48). Participants will complete an initial screening session to determine eligibility, followed by a baseline abstinence session in which measures of pain and withdrawal will be assessed following 24 hrs abstinence from smoking. At the conclusion of this session participants will receive training in ecological momentary assessment (EMA) procedures and software will be installed on their smartphone. Participants will then complete a 1-week baseline period, in which they will complete EMA while continuing to smoke usual brand cigarettes. During EMA, participants will receive 6 randomly spaced daily prompts, with 15 questions to complete about smoking behavior, mood, and current pain. In addition, participants will be asked to use their smartphone to indicate whenever they are about to smoke a cigarette. Three of these cigarettes each day will be randomly selected for assessment: in these cases participants will be asked to respond to the same 15 question before and after smoking the cigarette. Participants will also complete end of day questionnaires.

After the 1 week baseline period, participants will be randomly assigned to four weeks of either VLNCs (n=24) or normal nicotine content (NNC) cigarettes (n=24). During this period, participants will be asked to smoke only study cigarettes. Participants will attend weekly laboratory visits to provide biochemical verification of cigarette adherence (urine samples) and complete questionnaires. Study cigarettes will also be provided and collected at these visits. Two of the four weekly urine samples will be selected for analysis. Participants will also complete EMA during weeks 1 and 4 of study cigarette use. End of day questionnaires will continue throughout the 4 weeks.

At the conclusion of the study, participants will attend a final laboratory visit after abstaining from smoking for 24 hours. During this session, self-report measures of pain, craving, and withdrawal will be assessed, along with biochemical verification (breath sample) of abstinence.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Using Very Low Nicotine Cigarettes to Disrupt the Pain-smoking Reinforcement Cycle
• Actual Study Start Date: June 23, 2022
• Estimated Primary Completion Date: July 2023
• Estimated Study Completion Date: July 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: VLNC Group; 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; Very low nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes
Active Comparator: NNC Group; 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; Normal nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes

Outcome Measures

Primary Outcome Measures :

1. Change in dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD) [ Time Frame: Baseline, weekly for 5 weeks ]
   The FTCD is a widely used 6-item measure of dependence, with total scores ranging from 0 (low dependence) to 10 (high dependence)
2. Changes in abstinence-induced cigarette withdrawal as measured by the Minnesota Tobacco Withdrawal Scale (MNWS) [ Time Frame: Baseline abstinence session, follow-up abstinence session (immediately after 4 weeks of cigarette use) ]
   The MNWS is a 7-item measure of withdrawal symptoms, with responses indicated on a likert scale ranging from 0 (none) to 4 (severe)
3. Weekly changes in withdrawal symptoms as measured by the Minnesota Tobacco Withdrawal Scale [ Time Frame: Weekly for 5 visits ]
   The MNWS is a 7-item measure of withdrawal symptoms, with responses indicated on a likert scale ranging from 0 (none) to 4 (severe)
4. Changes in abstinence-induced craving as measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief) [ Time Frame: Baseline abstinence session, follow-up abstinence session (immediately after 4 weeks of cigarette use) ]
   The QSU-Brief is a 5-item measure of urge to smoke, with responses indicated on a 7-point likert scale ranging from 0 (strongly disagree) to 7 (strongly agree)
5. Weekly changes in craving as measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief) [ Time Frame: Weekly for 5 visits ]
   The QSU-Brief is a 5-item measure of urge to smoke, with responses indicated on a 7-point likert scale ranging from 0 (strongly disagree) to 7 (strongly agree)
6. Changes in pain intensity and interference during smoking abstinence as measured by the past 24-hour version of the Brief Pain Inventory (BPI) [ Time Frame: aseline abstinence session, follow-up abstinence session (immediately after 4 weeks of cigarette use) ]
   The BPI is a well-validated 11-item self-report measure yielding scores for pain intensity and interference, with higher scores indicated greater pain
7. Weekly changes in pain intensity and interference as measured by the past-week version of the Brief Pain Inventory (BPI) [ Time Frame: Weekly for 5 visits ]
   The BPI is a well-validated 11-item self-report measure yielding scores for pain intensity and interference, with higher scores indicated greater pain

Secondary Outcome Measures :

1. Changes in smoking abstinence self-efficacy as measured by the Smoking Self-Efficacy Questionnaire (SEQ-12) [ Time Frame: Weekly visits 1 and 5 ]
   The SEQ-12 is a 12-item measure yielding scores for self-efficacy when faced with both external (situational) or internal (e.g., affective) stimuli, with higher scores indicating greater confidence in abstaining from smoking
2. Changes in motivation to quit smoking as measured by the Contemplation Ladder [ Time Frame: Weekly visits 1 and 5 ]
   The contemplation ladder is a single-item measure of a person's current thoughts about quitting smoking, ranging from 0 (I have no thought of quitting) to 10 (I am doing something to try to quit)
3. Changes in smoking to cope with pain as measured by the Pain and Smoking Inventory (PSI) [ Time Frame: Weekly visits 1 and 5 ]
   The PSI is a 9-item measure of pain as a motivator to smoke, smoking to cope with pain, and pain as a barrier to smoking cessation, with responses indicated on a 7-point likert scale ranging from 0 (not true at all) to 6 (extremely true)

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 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

Contacts and Locations

Contacts

Contact: Maggie Sweitzer; 9196680094; maggie.sweitzer@duke.edu

Locations

United States, North Carolina

Duke University Medical Center; Recruiting

Durham, North Carolina, United States, 27705

Contact: Maggie Sweitzer, PhD 919-668-0094

Sponsors and Collaborators

Duke University

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Maggie Sweitzer; Duke University

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT05032755
• Other Study ID Numbers: Pro00108705; R21DA052729 ( U.S. NIH Grant/Contract )
• First Posted: September 2, 2021
• Last Update Posted: July 26, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations