Targeting Reinforcement Mechanisms for Smoking Cessation Using Very Low Nicotine Content Cigarettes in Individuals With Opioid Use Disorder and Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Nicotine Dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD)
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 craving, withdrawal, and pain among individuals with chronic pain who smoke cigarettes daily and are attending office-based buprenorphine treatment (OBBT).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 21+ years who smoke cigarettes daily
- •Chronic non-cancer musculoskeletal pain secondary to structural changes (e.g., low back pain, osteoarthritis)
- •Have received stable office-based buprenorphine treatment for opioid use disorder for at least 30 days
- •Self-report smoking at least 10 cigarettes/day
- •Expired breath carbon monoxide (CO) level >8 ppm
- •Have a smartphone capable of running software for ecological momentary assessment
- •Open to exploring the possibility of quitting smoking
排除标准
- •Pain specifically due to cancer
- •Other significant health problems
- •Major surgery within the past 6 months or planned surgery within the timeframe of the study
- •Current disability litigation
- •Use of electronic cigarettes or other non-cigarette tobacco products > 9 of the past 30 days
- •Current use of nicotine replacement therapy or other cessation treatment
- •Current daily or near-daily cannabis use
- •History of psychotic disorder
- •Acute suicidality or current unstable psychiatric disorder
- •Positive pregnancy test
- •Actively seeking smoking cessation treatment
研究组 & 干预措施
Normal Nicotine Cigarette (NNC) Group
Participants in this condition will be provided with NNCs and asked to switch to smoking only study cigarettes for 4 weeks.
干预措施: Normal Nicotine Cigarettes (NNC) (Behavioral)
Very Low Nicotine Cigarette (VLNC) Group
Participants in this condition will be provided with VLNCs and asked to switch to smoking only study cigarettes for 4 weeks.
干预措施: Very Low Nicotine Cigarettes (VLNC) (Behavioral)
结局指标
主要结局
Nicotine Dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD)
时间窗: Baseline and weekly during study cigarette use (4 weeks)
The FTCD has a total score of 0 to 10, where a greater score indicates a greater physical dependence on nicotine.
Cigarettes per Day
时间窗: Baseline and weekly during study cigarette use (4 weeks)
Average cigarettes smoked per day during the past week will be calculated using timeline follow-back methods
Pain as measured by the Brief Pain Inventory (BPI)
时间窗: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
The BPI has an averaged score of 0 to 10, where a greater score indicates greater pain.
Mechanical Hyperalgesia
时间窗: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions
Mechanical hyperalgesia is a condition that causes increased sensitivity to mechanical stimuli after an injury to the skin. Discriminability and response bias will be assessed using a computerized pressure algometer.
Smoking Withdrawal as measured by the Minnesota Withdrawal Scale (MNWS)
时间窗: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
The MNWS has a total score range of 0 to 68, where a higher score indicates greater symptoms of withdrawal.
Cigarette Craving as measured by the Questionnaire of Smoking Urges-Brief (QSU-B)
时间窗: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
The QSU-B has a total score range of 0 to 100, where a higher score indicates greater craving.
Cigarette Purchase Task - demand intensity
时间窗: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions
Outcomes for the cigarette purchase task will include demand intensity (i.e., consumption at $0) and Omax (i.e., max expenditure at any price point).
Cigarette Purchase Task - Omax
时间窗: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions
Outcomes for the cigarette purchase task will include demand intensity (i.e., consumption at $0) and Omax (i.e., max expenditure at any price point).
Pain-Smoking Associations as measured by Ecological Momentary Assessment (EMA)
时间窗: Baseline, weeks 1 and 4 of study cigarette use
EMA (also called experience sampling or daily diary method) involves repeated sampling of people's current experiences (e.g. pain) in real time in their natural environments.
Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - smoking frequency
时间窗: Baseline, weeks 1 and 4 of study cigarette use
Within-person variability in smoking frequency assessed via EMA before and after buprenorphine administration.
Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - craving
时间窗: Baseline, weeks 1 and 4 of study cigarette use
Within-person variability in smoking craving assessed via EMA before and after buprenorphine administration.
Opioid Withdrawal as measured by the Short Opioid Withdrawal Scale (SOWS)
时间窗: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)
The SOWS consists of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0-not at all, 1-a little, 2-moderately, 3-quite a bit, 4-extremely. The total score ranges from 0 to 64, where a higher score indicates greater symptoms of withdrawal.
次要结局
- Number of participants willing to Quit Smoking(post-intervention, after 24 hrs abstinence)
- Smoking abstinence self-efficacy as measured by the Self-Efficacy Questionnaire (SEQ)(Weekly visits 1 and 5)
- Pain and Smoking Inventory (PSI)(Weekly visits 1 and 5)
- Barriers to Quitting Smoking in Substance Abuse Treatment (BSQ-SAT)(Weekly visits 1 and 5)