Chronic Pain, Smoking, Cigarette
Conditions
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.
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.
Interventions
OTHERSPECTRUM NRC 102/103 investigational cigarettes
Very low nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes
OTHERSPECTRUM NRC 600/601 investigational cigarettes
Normal nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes
Sponsors
National Institute on Drug Abuse (NIDA)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratings of Withdrawal Symptoms During Smoking Abstinence, as Measured by the Minnesota Tobacco Withdrawal Scale (MNWS) | 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) | 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. |
| Cigarettes Smoked Per Day | Weekly for 5 weeks | Average number of cigarettes smoked per day over the past week, as reported on timeline follow-back interview at each weekly visit |
| Weekly Measures of Cigarette Dependence as Assessed by the Fagerstrom Test of Cigarette Dependence (FTCD) | 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) |
| Weekly Ratings of Withdrawal Symptoms as Measured by the Minnesota Tobacco Withdrawal Scale | 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). The total score ranges from 0 to 28, with higher scores indicating greater withdrawal symptoms. |
| Weekly Changes in Pain Intensity as Measured by the Past-week Version of the Brief Pain Inventory (BPI) | Weekly for 5 visits | 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. |
| Pain Intensity During Smoking Abstinence as Measured by the Past 24-hour Version of the Brief Pain Inventory (BPI) | 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) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Smoking to Cope With Pain as Measured by the Pain and Smoking Inventory (PSI) | Weekly visits 1, 3, 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). Scores are averaged and the total score ranges from 0-6, with higher scores indicating that pain is a greater motivator to smoke. |
| Intent to Smoke During Ecological Momentary Assessment | Baseline (pre-randomization; i.e., week 1) and the first and last weeks of study cigarette use (i.e., weeks 2 and 5) | Proportion of yes responses to question Are you about to smoke a cigarette right now?, assessed multiple times during the day. Total yes responses were divided by total observations within each week to calculate proportion of responses. |
| Changes in Motivation to Quit Smoking as Measured by the Contemplation Ladder | Weekly visits 1, 3, 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) |
| Changes in Smoking Abstinence Self-efficacy as Measured by the Smoking Self-Efficacy Questionnaire (SEQ-12) | Weekly visits 1, 3, 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. Responses on each item range from 1 to 5, with higher scores indicating greater confidence in abstaining from smoking. Total score ranges from 12 to 60. |
| Pain Intensity Ratings During Ecological Momentary Assessment | Baseline (pre-randomization; i.e., week 1) and the first and last weeks of study cigarette use (i.e., weeks 2 and 5) | Responses to the question Right now, how intense is your pain?, rated on a 1 (not at all) to 9 (extremely) likert scale at multiple timepoints throughout the day over the course of a week. All responses recorded within a week (up to 35 per participant) were averaged to create a single value ranging from 1 to 9, with higher scores indicating more pain. |
| Smoking Urge Ratings During Ecological Momentary Assessment | Baseline (pre-randomization; i.e., week 1) and the first and last weeks of study cigarette use (i.e., weeks 2 and 5) | Responses to question How strong is your current urge to smoke?, rated on a 1 (not strong at all) to 9 (extremely strong) likert scale, assessed at multiple timepoints each day. All responses recorded within a week (up to 35 per participant) were averaged to create a single value ranging from 1 to 9, with higher scores indicating greater smoking urge. |
| Negative Affect Ratings During Ecological Momentary Assessment | Baseline (pre-randomization; i.e., week 1), and the first and last weeks of study cigarette use (i.e., weeks 2 and 5) | Average of responses to 4 negative affect items (anxious, irritable, guilty sad) using the question prompt, Right now, how much are you feeling...?, rated on a 1 (not at all) to 9 (extremely) likert scale, assessed at multiple times per day. All responses recorded within a week (up to 35 per participant) were averaged to create a single value ranging from 1 to 9, with higher scores indicating greater negative affect. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from Duke University Medical Center and the surrounding area from August, 2023 through May, 2024.
Pre-assignment details
A total of 40 participants were determined to be eligible and enrolled in the study. Of these, 5 withdrew prior to randomization due to scheduling difficulty (n=2), PI decision following repeated no-shows (n=1), inability to abstain from smoking for the baseline abstinent visit (n=1) and loss to contact (n=1).
Participants by arm
| Arm | Count |
|---|---|
| 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.
SPECTRUM NRC 102/103 investigational cigarettes: Very low nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes | 19 |
| 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.
SPECTRUM NRC 600/601 investigational cigarettes: Normal nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes | 16 |
| Total | 35 |
Baseline characteristics
| Characteristic | VLNC Group | Total | NNC Group |
|---|---|---|---|
| Age, Continuous | 50.6 years STANDARD_DEVIATION 9.69 | 50.3 years STANDARD_DEVIATION 8.9 | 49.8 years STANDARD_DEVIATION 8.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 34 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 25 Participants | 11 Participants |
| Region of Enrollment United States | 19 participants | 35 participants | 16 participants |
| Sex: Female, Male Female | 11 Participants | 22 Participants | 11 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 16 |
| other Total, other adverse events | 12 / 19 | 13 / 16 |
| serious Total, serious adverse events | 0 / 19 | 0 / 16 |
Outcome results
Primary
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
Time frame: Weekly for 5 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VLNC Group | Cigarettes Smoked Per Day | Week 2 | 16.4 cigarettes/day | Standard Deviation 8.99 |
| VLNC Group | Cigarettes Smoked Per Day | Week 4 | 13.8 cigarettes/day | Standard Deviation 7.84 |
| VLNC Group | Cigarettes Smoked Per Day | Week 3 | 13.5 cigarettes/day | Standard Deviation 7.15 |
| VLNC Group | Cigarettes Smoked Per Day | Week 5 | 14.0 cigarettes/day | Standard Deviation 8.95 |
| VLNC Group | Cigarettes Smoked Per Day | Week 1 | 14.5 cigarettes/day | Standard Deviation 5.54 |
| NNC Group | Cigarettes Smoked Per Day | Week 5 | 23.8 cigarettes/day | Standard Deviation 8.09 |
| NNC Group | Cigarettes Smoked Per Day | Week 1 | 17.2 cigarettes/day | Standard Deviation 7.39 |
| NNC Group | Cigarettes Smoked Per Day | Week 2 | 20.3 cigarettes/day | Standard Deviation 6.49 |
| NNC Group | Cigarettes Smoked Per Day | Week 3 | 23.4 cigarettes/day | Standard Deviation 5.86 |
| NNC Group | Cigarettes Smoked Per Day | Week 4 | 22.5 cigarettes/day | Standard Deviation 5.87 |
p-value: <0.0001Mixed Models Analysis
Primary
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VLNC Group | Pain Intensity During Smoking Abstinence as Measured by the Past 24-hour Version of the Brief Pain Inventory (BPI) | Week 1 (pre-intervention) abstinence session | 4.53 score on a scale | Standard Deviation 2.06 |
| VLNC Group | Pain Intensity During Smoking Abstinence as Measured by the Past 24-hour Version of the Brief Pain Inventory (BPI) | Week 5 (post-intervention) abstinence session | 3.51 score on a scale | Standard Deviation 2.26 |
| NNC Group | Pain Intensity During Smoking Abstinence as Measured by the Past 24-hour Version of the Brief Pain Inventory (BPI) | Week 1 (pre-intervention) abstinence session | 3.83 score on a scale | Standard Deviation 1.78 |
| NNC Group | Pain Intensity During Smoking Abstinence as Measured by the Past 24-hour Version of the Brief Pain Inventory (BPI) | Week 5 (post-intervention) abstinence session | 2.85 score on a scale | Standard Deviation 1.64 |
Primary
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VLNC Group | Ratings of Withdrawal Symptoms During Smoking Abstinence, as Measured by the Minnesota Tobacco Withdrawal Scale (MNWS) | Week 1 (pre-intervention) abstinence session | 13.2 score on a scale | Standard Deviation 5.8 |
| VLNC Group | Ratings of Withdrawal Symptoms During Smoking Abstinence, as Measured by the Minnesota Tobacco Withdrawal Scale (MNWS) | Week 5 (post-intervention) abstinence session | 8.63 score on a scale | Standard Deviation 5.93 |
| NNC Group | Ratings of Withdrawal Symptoms During Smoking Abstinence, as Measured by the Minnesota Tobacco Withdrawal Scale (MNWS) | Week 1 (pre-intervention) abstinence session | 14.4 score on a scale | Standard Deviation 4.56 |
| NNC Group | Ratings of Withdrawal Symptoms During Smoking Abstinence, as Measured by the Minnesota Tobacco Withdrawal Scale (MNWS) | Week 5 (post-intervention) abstinence session | 11.6 score on a scale | Standard Deviation 4.66 |
p-value: 0.325Mixed Models Analysis
Primary
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.
Time frame: Weekly for 5 visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VLNC Group | Weekly Changes in Pain Intensity as Measured by the Past-week Version of the Brief Pain Inventory (BPI) | Week 2 | 4.97 score on a scale | Standard Deviation 1.8 |
| VLNC Group | Weekly Changes in Pain Intensity as Measured by the Past-week Version of the Brief Pain Inventory (BPI) | Week 4 | 4.05 score on a scale | Standard Deviation 2.3 |
| VLNC Group | Weekly Changes in Pain Intensity as Measured by the Past-week Version of the Brief Pain Inventory (BPI) | Week 3 | 4.61 score on a scale | Standard Deviation 2.4 |
| VLNC Group | Weekly Changes in Pain Intensity as Measured by the Past-week Version of the Brief Pain Inventory (BPI) | Week 5 | 3.84 score on a scale | Standard Deviation 1.95 |
| VLNC Group | Weekly Changes in Pain Intensity as Measured by the Past-week Version of the Brief Pain Inventory (BPI) | Week 1 | 5.1 score on a scale | Standard Deviation 1.89 |
| NNC Group | Weekly Changes in Pain Intensity as Measured by the Past-week Version of the Brief Pain Inventory (BPI) | Week 5 | 4.29 score on a scale | Standard Deviation 1.99 |
| NNC Group | Weekly Changes in Pain Intensity as Measured by the Past-week Version of the Brief Pain Inventory (BPI) | Week 1 | 4.04 score on a scale | Standard Deviation 1.02 |
| NNC Group | Weekly Changes in Pain Intensity as Measured by the Past-week Version of the Brief Pain Inventory (BPI) | Week 2 | 3.88 score on a scale | Standard Deviation 1.12 |
| NNC Group | Weekly Changes in Pain Intensity as Measured by the Past-week Version of the Brief Pain Inventory (BPI) | Week 3 | 4.23 score on a scale | Standard Deviation 1.85 |
| NNC Group | Weekly Changes in Pain Intensity as Measured by the Past-week Version of the Brief Pain Inventory (BPI) | Week 4 | 3.98 score on a scale | Standard Deviation 2.17 |
p-value: 0.007Mixed Models Analysis
Primary
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)
Time frame: Weekly for 5 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VLNC Group | Weekly Measures of Cigarette Dependence as Assessed by the Fagerstrom Test of Cigarette Dependence (FTCD) | Week 2 | 4.32 score on a scale | Standard Deviation 2.31 |
| VLNC Group | Weekly Measures of Cigarette Dependence as Assessed by the Fagerstrom Test of Cigarette Dependence (FTCD) | Week 4 | 3.84 score on a scale | Standard Deviation 2.34 |
| VLNC Group | Weekly Measures of Cigarette Dependence as Assessed by the Fagerstrom Test of Cigarette Dependence (FTCD) | Week 3 | 4.11 score on a scale | Standard Deviation 2.35 |
| VLNC Group | Weekly Measures of Cigarette Dependence as Assessed by the Fagerstrom Test of Cigarette Dependence (FTCD) | Week 5 | 4.16 score on a scale | Standard Deviation 2.34 |
| VLNC Group | Weekly Measures of Cigarette Dependence as Assessed by the Fagerstrom Test of Cigarette Dependence (FTCD) | Week 1 | 4.95 score on a scale | Standard Deviation 2.12 |
| NNC Group | Weekly Measures of Cigarette Dependence as Assessed by the Fagerstrom Test of Cigarette Dependence (FTCD) | Week 5 | 6.25 score on a scale | Standard Deviation 1.73 |
| NNC Group | Weekly Measures of Cigarette Dependence as Assessed by the Fagerstrom Test of Cigarette Dependence (FTCD) | Week 1 | 5.56 score on a scale | Standard Deviation 1.59 |
| NNC Group | Weekly Measures of Cigarette Dependence as Assessed by the Fagerstrom Test of Cigarette Dependence (FTCD) | Week 2 | 5.88 score on a scale | Standard Deviation 1.78 |
| NNC Group | Weekly Measures of Cigarette Dependence as Assessed by the Fagerstrom Test of Cigarette Dependence (FTCD) | Week 3 | 6.19 score on a scale | Standard Deviation 1.56 |
| NNC Group | Weekly Measures of Cigarette Dependence as Assessed by the Fagerstrom Test of Cigarette Dependence (FTCD) | Week 4 | 6.12 score on a scale | Standard Deviation 1.67 |
p-value: <0.0001Mixed Models Analysis
Primary
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.
Time frame: Weekly for 5 visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VLNC Group | Weekly Ratings of Withdrawal Symptoms as Measured by the Minnesota Tobacco Withdrawal Scale | Week 2 | 12.42 score on a scale | Standard Deviation 6.31 |
| VLNC Group | Weekly Ratings of Withdrawal Symptoms as Measured by the Minnesota Tobacco Withdrawal Scale | Week 4 | 9.84 score on a scale | Standard Deviation 6.27 |
| VLNC Group | Weekly Ratings of Withdrawal Symptoms as Measured by the Minnesota Tobacco Withdrawal Scale | Week 3 | 12.32 score on a scale | Standard Deviation 6.25 |
| VLNC Group | Weekly Ratings of Withdrawal Symptoms as Measured by the Minnesota Tobacco Withdrawal Scale | Week 5 | 10.42 score on a scale | Standard Deviation 5.64 |
| VLNC Group | Weekly Ratings of Withdrawal Symptoms as Measured by the Minnesota Tobacco Withdrawal Scale | Week 1 | 12.05 score on a scale | Standard Deviation 5.64 |
| NNC Group | Weekly Ratings of Withdrawal Symptoms as Measured by the Minnesota Tobacco Withdrawal Scale | Week 5 | 10.69 score on a scale | Standard Deviation 3.44 |
| NNC Group | Weekly Ratings of Withdrawal Symptoms as Measured by the Minnesota Tobacco Withdrawal Scale | Week 1 | 10.69 score on a scale | Standard Deviation 4.25 |
| NNC Group | Weekly Ratings of Withdrawal Symptoms as Measured by the Minnesota Tobacco Withdrawal Scale | Week 2 | 10.38 score on a scale | Standard Deviation 4.72 |
| NNC Group | Weekly Ratings of Withdrawal Symptoms as Measured by the Minnesota Tobacco Withdrawal Scale | Week 3 | 12.38 score on a scale | Standard Deviation 3.95 |
| NNC Group | Weekly Ratings of Withdrawal Symptoms as Measured by the Minnesota Tobacco Withdrawal Scale | Week 4 | 11.25 score on a scale | Standard Deviation 5.53 |
p-value: 0.065Mixed Models Analysis
Post Hoc
Changes in Abstinence-induced Craving as Measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)
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). Total scores range from 0 to 35, with higher scores indicating greater craving.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VLNC Group | Changes in Abstinence-induced Craving as Measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief) | Week 1 (pre-intervention) abstinence session | 26.3 score on a scale | Standard Deviation 5.75 |
| VLNC Group | Changes in Abstinence-induced Craving as Measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief) | Week 5 (post-intervention) abstinence session | 16.7 score on a scale | Standard Deviation 9.42 |
| NNC Group | Changes in Abstinence-induced Craving as Measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief) | Week 1 (pre-intervention) abstinence session | 26.7 score on a scale | Standard Deviation 6.34 |
| NNC Group | Changes in Abstinence-induced Craving as Measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief) | Week 5 (post-intervention) abstinence session | 21.8 score on a scale | Standard Deviation 7.57 |
p-value: 0.113Mixed Models Analysis
Other Pre-specified
Changes in Motivation to Quit Smoking as Measured by the Contemplation Ladder
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)
Time frame: Weekly visits 1, 3, and 5
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VLNC Group | Changes in Motivation to Quit Smoking as Measured by the Contemplation Ladder | Week 1 | 5 score on a scale | Standard Deviation 3.06 |
| VLNC Group | Changes in Motivation to Quit Smoking as Measured by the Contemplation Ladder | Week 3 | 5.26 score on a scale | Standard Deviation 2.75 |
| VLNC Group | Changes in Motivation to Quit Smoking as Measured by the Contemplation Ladder | Week 5 | 5.95 score on a scale | Standard Deviation 3.06 |
| NNC Group | Changes in Motivation to Quit Smoking as Measured by the Contemplation Ladder | Week 1 | 3.88 score on a scale | Standard Deviation 2.55 |
| NNC Group | Changes in Motivation to Quit Smoking as Measured by the Contemplation Ladder | Week 3 | 5.31 score on a scale | Standard Deviation 2.57 |
| NNC Group | Changes in Motivation to Quit Smoking as Measured by the Contemplation Ladder | Week 5 | 5.63 score on a scale | Standard Deviation 3.18 |
p-value: 0.27Mixed Models Analysis
Other Pre-specified
Changes in Smoking Abstinence Self-efficacy as Measured by the Smoking Self-Efficacy Questionnaire (SEQ-12)
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. Responses on each item range from 1 to 5, with higher scores indicating greater confidence in abstaining from smoking. Total score ranges from 12 to 60.
Time frame: Weekly visits 1, 3, and 5
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VLNC Group | Changes in Smoking Abstinence Self-efficacy as Measured by the Smoking Self-Efficacy Questionnaire (SEQ-12) | Week 1 | 24.11 score on a scale | Standard Deviation 6.88 |
| VLNC Group | Changes in Smoking Abstinence Self-efficacy as Measured by the Smoking Self-Efficacy Questionnaire (SEQ-12) | Week 3 | 29.68 score on a scale | Standard Deviation 11.72 |
| VLNC Group | Changes in Smoking Abstinence Self-efficacy as Measured by the Smoking Self-Efficacy Questionnaire (SEQ-12) | Week 5 | 27.21 score on a scale | Standard Deviation 8.64 |
| NNC Group | Changes in Smoking Abstinence Self-efficacy as Measured by the Smoking Self-Efficacy Questionnaire (SEQ-12) | Week 1 | 27.44 score on a scale | Standard Deviation 11.12 |
| NNC Group | Changes in Smoking Abstinence Self-efficacy as Measured by the Smoking Self-Efficacy Questionnaire (SEQ-12) | Week 3 | 31 score on a scale | Standard Deviation 8.92 |
| NNC Group | Changes in Smoking Abstinence Self-efficacy as Measured by the Smoking Self-Efficacy Questionnaire (SEQ-12) | Week 5 | 25.63 score on a scale | Standard Deviation 6.51 |
p-value: 0.24Mixed Models Analysis
Other Pre-specified
Changes in Smoking to Cope With Pain as Measured by the Pain and Smoking Inventory (PSI)
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). Scores are averaged and the total score ranges from 0-6, with higher scores indicating that pain is a greater motivator to smoke.
Time frame: Weekly visits 1, 3, and 5
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VLNC Group | Changes in Smoking to Cope With Pain as Measured by the Pain and Smoking Inventory (PSI) | Week 1 | 2.87 score on a scale | Standard Deviation 1.79 |
| VLNC Group | Changes in Smoking to Cope With Pain as Measured by the Pain and Smoking Inventory (PSI) | Week 3 | 2.61 score on a scale | Standard Deviation 1.77 |
| VLNC Group | Changes in Smoking to Cope With Pain as Measured by the Pain and Smoking Inventory (PSI) | Week 5 | 2.13 score on a scale | Standard Deviation 1.86 |
| NNC Group | Changes in Smoking to Cope With Pain as Measured by the Pain and Smoking Inventory (PSI) | Week 1 | 2.29 score on a scale | Standard Deviation 1.16 |
| NNC Group | Changes in Smoking to Cope With Pain as Measured by the Pain and Smoking Inventory (PSI) | Week 3 | 2.52 score on a scale | Standard Deviation 1.46 |
| NNC Group | Changes in Smoking to Cope With Pain as Measured by the Pain and Smoking Inventory (PSI) | Week 5 | 2.44 score on a scale | Standard Deviation 1.33 |
p-value: 0.035Mixed Models Analysis
Other Pre-specified
Intent to Smoke During Ecological Momentary Assessment
Proportion of yes responses to question Are you about to smoke a cigarette right now?, assessed multiple times during the day. Total yes responses were divided by total observations within each week to calculate proportion of responses.
Time frame: Baseline (pre-randomization; i.e., week 1) and the first and last weeks of study cigarette use (i.e., weeks 2 and 5)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VLNC Group | Intent to Smoke During Ecological Momentary Assessment | Week 1 (Baseline) | 0.35 proportion of responses | Standard Deviation 0.48 |
| VLNC Group | Intent to Smoke During Ecological Momentary Assessment | Week 2 | 0.38 proportion of responses | Standard Deviation 0.49 |
| VLNC Group | Intent to Smoke During Ecological Momentary Assessment | Week 5 | 0.21 proportion of responses | Standard Deviation 0.41 |
| NNC Group | Intent to Smoke During Ecological Momentary Assessment | Week 1 (Baseline) | 0.26 proportion of responses | Standard Deviation 0.44 |
| NNC Group | Intent to Smoke During Ecological Momentary Assessment | Week 2 | 0.30 proportion of responses | Standard Deviation 0.46 |
| NNC Group | Intent to Smoke During Ecological Momentary Assessment | Week 5 | 0.32 proportion of responses | Standard Deviation 0.47 |
Other Pre-specified
Negative Affect Ratings During Ecological Momentary Assessment
Average of responses to 4 negative affect items (anxious, irritable, guilty sad) using the question prompt, Right now, how much are you feeling...?, rated on a 1 (not at all) to 9 (extremely) likert scale, assessed at multiple times per day. All responses recorded within a week (up to 35 per participant) were averaged to create a single value ranging from 1 to 9, with higher scores indicating greater negative affect.
Time frame: Baseline (pre-randomization; i.e., week 1), and the first and last weeks of study cigarette use (i.e., weeks 2 and 5)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VLNC Group | Negative Affect Ratings During Ecological Momentary Assessment | Week 1 (Baseline) | 2.44 units on a scale | Standard Deviation 1.21 |
| VLNC Group | Negative Affect Ratings During Ecological Momentary Assessment | Week 2 | 2.98 units on a scale | Standard Deviation 1.61 |
| VLNC Group | Negative Affect Ratings During Ecological Momentary Assessment | Week 5 | 2.43 units on a scale | Standard Deviation 1.6 |
| NNC Group | Negative Affect Ratings During Ecological Momentary Assessment | Week 1 (Baseline) | 1.89 units on a scale | Standard Deviation 0.91 |
| NNC Group | Negative Affect Ratings During Ecological Momentary Assessment | Week 2 | 1.91 units on a scale | Standard Deviation 1.13 |
| NNC Group | Negative Affect Ratings During Ecological Momentary Assessment | Week 5 | 2.05 units on a scale | Standard Deviation 1.03 |
Other Pre-specified
Pain Intensity Ratings During Ecological Momentary Assessment
Responses to the question Right now, how intense is your pain?, rated on a 1 (not at all) to 9 (extremely) likert scale at multiple timepoints throughout the day over the course of a week. All responses recorded within a week (up to 35 per participant) were averaged to create a single value ranging from 1 to 9, with higher scores indicating more pain.
Time frame: Baseline (pre-randomization; i.e., week 1) and the first and last weeks of study cigarette use (i.e., weeks 2 and 5)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VLNC Group | Pain Intensity Ratings During Ecological Momentary Assessment | Week 1 (Baseline) | 4.40 units on a scale | Standard Deviation 1.88 |
| VLNC Group | Pain Intensity Ratings During Ecological Momentary Assessment | Week 2 | 4.23 units on a scale | Standard Deviation 2.06 |
| VLNC Group | Pain Intensity Ratings During Ecological Momentary Assessment | Week 5 | 3.67 units on a scale | Standard Deviation 2.1 |
| NNC Group | Pain Intensity Ratings During Ecological Momentary Assessment | Week 1 (Baseline) | 3.23 units on a scale | Standard Deviation 1.54 |
| NNC Group | Pain Intensity Ratings During Ecological Momentary Assessment | Week 2 | 3.09 units on a scale | Standard Deviation 1.55 |
| NNC Group | Pain Intensity Ratings During Ecological Momentary Assessment | Week 5 | 3.05 units on a scale | Standard Deviation 1.57 |
Other Pre-specified
Smoking Urge Ratings During Ecological Momentary Assessment
Responses to question How strong is your current urge to smoke?, rated on a 1 (not strong at all) to 9 (extremely strong) likert scale, assessed at multiple timepoints each day. All responses recorded within a week (up to 35 per participant) were averaged to create a single value ranging from 1 to 9, with higher scores indicating greater smoking urge.
Time frame: Baseline (pre-randomization; i.e., week 1) and the first and last weeks of study cigarette use (i.e., weeks 2 and 5)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VLNC Group | Smoking Urge Ratings During Ecological Momentary Assessment | Week 1 (Baseline) | 4.74 units on a scale | Standard Deviation 2.47 |
| VLNC Group | Smoking Urge Ratings During Ecological Momentary Assessment | Week 2 | 4.43 units on a scale | Standard Deviation 2.32 |
| VLNC Group | Smoking Urge Ratings During Ecological Momentary Assessment | Week 5 | 3.23 units on a scale | Standard Deviation 2.33 |
| NNC Group | Smoking Urge Ratings During Ecological Momentary Assessment | Week 1 (Baseline) | 3.78 units on a scale | Standard Deviation 2.26 |
| NNC Group | Smoking Urge Ratings During Ecological Momentary Assessment | Week 2 | 3.40 units on a scale | Standard Deviation 2.09 |
| NNC Group | Smoking Urge Ratings During Ecological Momentary Assessment | Week 5 | 3.98 units on a scale | Standard Deviation 2.39 |