Using Very Low Nicotine Cigarettes to Disrupt the Pain-smoking Reinforcement Cycle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain Intensity During Smoking Abstinence as Measured by the Past 24-hour Version of the Brief Pain Inventory (BPI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Pain Intensity During Smoking Abstinence as Measured by the Past 24-hour Version of the Brief Pain Inventory (BPI)
时间窗: 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.
Cigarettes Smoked Per Day
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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.
Ratings of Withdrawal Symptoms During Smoking Abstinence, as Measured by the Minnesota Tobacco Withdrawal Scale (MNWS)
时间窗: 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.
Pain Intensity During Smoking Abstinence as Measured by the Past 24-hour Version of the Brief Pain Inventory (BPI)
时间窗: 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.
次要结局
未报告次要终点