UW Withdraw From Tobacco Study: Enhancing and Evaluating Tobacco Withdrawal Assessment Psychometrics and Validity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L)
研究概览
简要总结
It is of considerable scientific and clinical importance to assess tobacco withdrawal accurately since withdrawal severity is highly determinant of smoking cessation success. In addition, smoking cessation pharmacotherapy produces its effects on smoking abstinence by suppressing such symptoms. However, in order to ensure that a measure of tobacco withdrawal is sensitive to severe withdrawal, it is essential to examine a period of unmedicated abstinence. The current study aims to validate, and possibly enhance, a revised Wisconsin Smoking Withdrawal Scale long and brief version for use in research and clinical settings.
Two hundred adults who smoke cigarettes daily and report a desire to quit smoking will be enrolled. This is a treatment-delay, one-group clinical trial that is intended to enhance the assessment of tobacco withdrawal amongst participants who try to quit smoking with delayed use of cessation medication. Participants will not receive any pharmacotherapy during the first 1 week of their quit attempt and will initiate 8 weeks of combination nicotine replacement therapy (C-NRT; nicotine patch + nicotine mini-lozenge) starting 1 week past the target quit day (TQD). Participants will receive 4 counseling sessions as well (1 pre-quit, 3 post-quit). Participants will complete 4 weeks of ecological momentary assessment (EMA) smartphone surveys including a 2-week baseline (starting TQD-14) and 2-week post-TQD (1-week un-medicated, 1-week using C-NRT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Smoke ≥5 cigarettes per day for past year
- •≥21 years old
- •Able to read and write English
- •Desire to quit smoking
- •Not currently engaged in cessation treatment
- •Eligible to use combination nicotine replacement therapy
- •Willing and able to attend study visits
- •Have reliable smartphone access
- •Not currently pregnant, trying to get pregnant, or breastfeeding
- •Willing to respond to ecological momentary assessment prompts and other study activities
- •Baseline breath carbon monoxide (CO) ≥5ppm
排除标准
- •Used pipe tobacco, cigars, snuff, or chew more than twice in the past week
- •Used e-cigarette, vaping, or any other electronic nicotine delivery product more than twice in the past week
- •Unwilling to try to abstain from all non-medicinal nicotine use (including e-cigarettes) for the duration of the Cessation Phase (other than nicotine replacement therapy provided by the study)
- •Currently taking varenicline or bupropion
- •Allergy to adhesive tape
- •Previous reaction to the nicotine patch or mini-lozenge that prevented them from continuing to use it
- •Unwilling to use study approved methods of birth control while taking study medication and for 1 month after discontinuing study medication [only for women of child-bearing potential]
- •Hospitalized for a stroke, heart attack, congestive heart failure, ulcers, or diabetes within the last year
- •History of seizure within the last year
- •Diagnosis of and/or treatment for schizophrenia, other psychotic disorders, or bipolar disorder within the last 5 years
- •End-stage renal disease
- •Suicide attempt or suicidal ideation within the last 12 months
- •Severe hypertension > 180/100 mmHg
研究组 & 干预措施
Nicotine Patch + Nicotine Mini Lozenge
No medication for 1 Week after Target Quit Day (TQD). Medication started 1 Week after TQD.
Patches (Nicotine): 14 mg Patches for 4 weeks postquit (Week 1-5), then 7 mg patches for 4 weeks (Week 6-9)
Mini Lozenge (Nicotine): 2 mg Mini Lozenges 5x per day (up to 20x day max) for 8 weeks post quit (Week 1-9)
干预措施: Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge) (Drug)
结局指标
主要结局
Change in Total Score on Wisconsin Smoking Withdrawal Scale2 Long (WSWS2-L)
时间窗: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Self-reported withdrawal symptom severity in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2(WSWS-2) Long Version. WSWS-2 consists of 19 items. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours. Mean score from 1-7 is reported. Higher scores indicate more severe withdrawal symptoms.
Change in Wisconsin Smoking Withdrawal Scale2 Brief Score
时间窗: pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks)
Self-reported withdrawal symptom severity in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2(WSWS-2) Brief Version. WSWS-2 consists of 6 items. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours. Higher scores indicate more severe withdrawal symptoms.
次要结局
- Change in WSWS2-L Subscale Score : Craving(pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks))
- Change in WSWS2-L Subscale Score : Negative Affect(pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks))
- Change in WSWS2-L Subscale Score : Sleep Problems(pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks))
- Change in WSWS2-L Subscale Score : Restlessness(pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks))
- Change in WSWS2-L Subscale Score : Concentration(pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks))
- Change in WSWS2-L Subscale Score: Hunger(pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks))
- 9-Week Point-Prevalence Abstinence: Number of Participants Who Were Abstinent(9 weeks after quit date)
- Change in Total Score on Minnesota Tobacco Withdrawal Scale (MTWS)(pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks))
- Change in WSWS2-L Subscale Score: Anhedonia(pre-quit (2 weeks, 1 week, 1-3 days) and post-quit (1-2 days, 1 week, 2 weeks))