Emergency Department Based Management of Tobacco Use Disorder
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 100
- 主要终点
- Heaviness of Smoking Index (Baseline)
研究概览
简要总结
The objective of this study is to determine the effectiveness of ED initiated NRT on tobacco cessation point abstinence rates as reported by patients at 2 weeks and 1 month post randomization, and continued abstinence rates at 3 months compared to standard of care therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current daily use cigarettes greater than or equal to ½ pack per day
- •Stable for discharge from the ED
- •Able and willing to complete telephone/electronic follow up at scheduled intervals
- •Reported English speaking
排除标准
- •Patients enrolled in specific health insurance plans (PEIA, The Health Plan or Medicaid medical insurance)
- •WVU students
- •Medically unstable patients
- •Patients with clinical decompensation or who are admitted to the hospital
- •Patients who are discharged to residential treatment facilities for detoxification
- •Uncontrolled psychiatric disorder or psychiatric emergency
- •Individuals who are unable to provide consent
- •Incarcerated individuals
- •Language barrier
- •Currently pregnant or attempting to become pregnant
- •Presenting for evaluation of sexual assault
- •Known allergy or previous intolerance to nicotine replacement therapy
结局指标
主要结局
Heaviness of Smoking Index (Baseline)
时间窗: Baseline
A validated measure used to determine the level of nicotine addiction, with a scale of 0-6 (3 indicates moderate addiction, \>5 is severe)
Percentage of Continued Abstinence Rate (1 month)
时间窗: 1 Month post initial dose
Percentage of subjects who self-report continued abstinence in tobacco use at 1 month from initial dose given during the ED visit.
Patient Health Questionnaire 2 (Baseline)
时间窗: Baseline
A validated instrument to assess the frequency of depression and anhedonia screen for depression, scores can range from 0 to 6, with each item scored from 0 (not at all) to 3 (nearly every day). Scores greater than or equal to typically indicate depression.
Percentage of Continued Abstinence Rate (2 weeks)
时间窗: 2 Weeks post initial dose
Percentage of subjects who self-report continued abstinence in tobacco use at 2 weeks from initial dose given during the ED visit.
Percentage of Continued Abstinence Rate (3 months)
时间窗: 3 Months post initial dose
Percentage of subjects who self-report continued abstinence in tobacco use at 3 months from initial dose given during the ED visit.
Heaviness of Smoking Index (3 months from baseline)
时间窗: 3 months from baseline
A validated measure used to determine the level of nicotine addiction, with a scale of 0-6 (3 indicates moderate addiction, \>5 is severe)
Richmond Test (3 months from baseline)
时间窗: 3 months from baseline
A validated instrument to assess motivation to quit smoking. This is scored on a 0-10 scale with 5-6 indicating moderate motivation to quit and 7+ indicating strong motivation to quit.
Patient Health Questionnaire 2 (3 months from baseline)
时间窗: 3 months from baseline
A validated instrument to assess the frequency of depression and anhedonia screen for depression, scores can range from 0 to 6, with each item scored from 0 (not at all) to 3 (nearly every day). Scores greater than or equal to typically indicate depression.
Richmond Test (Baseline)
时间窗: Baseline
A validated instrument to assess motivation to quit smoking. This is scored on a 0-10 scale with 5-6 indicating moderate motivation to quit and 7+ indicating strong motivation to quit.
次要结局
未报告次要终点
研究者
Bradley End
Assistant Professor
West Virginia University