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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
40
Very low nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes
Normal nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes
Duke University Medical Center
Durham, North Carolina, United States
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
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
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
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
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)
Pain Intensity During Smoking Abstinence as Measured by the Past 24-hour Version of the Brief Pain Inventory (BPI)
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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)