NCT00497068已完成2 期
Tobacco Use in Opioid Agonist Treated Pregnant Women
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score
研究概览
简要总结
The primary objective of the proposed study is to evaluate the efficacy of tobacco abstinence-contingent voucher incentives versus non-tobacco abstinence-contingent incentives for reducing or eliminating tobacco use during pregnancy in methadone treated women. In addition, the impact that this intervention has in reducing the incidence and severity of methadone associated neonatal abstinence syndrome will also be examined.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed pregnancy
- •Treatment entry at or before 31 weeks EGA
- •Expected to enter drug-free outpatient modality at CAP
- •Placed on methadone pharmacotherapy
- •Nicotine dependent
- •Sufficient literacy and understanding for assessment procedures
- •Expected availability for study duration (e.g., complete inpatient stay)
- •Able and willing to provide informed consent
- •At least 18 years of age
- •Confirmed smoker of 10 or more cigarettes
排除标准
- •Not pregnant
- •EGA of 32 weeks or greater
- •17 years of age or younger
- •Undergoing detoxification (non-methadone treatment)
- •Unable to provide informed consent
- •Currently receiving nicotine replacement products (NRT)
- •Current diagnosis of alcohol or benzodiazepine dependence
- •Severe medical or psychiatric concomitant conditions that would interfere with treatment or require extended hospitalization.
结局指标
主要结局
Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score
时间窗: from treatment entry until 6 weeks post-partum
次要结局
- tobacco use measures • treatment compliance• Neonatal measures include:Birth parameters(from treatment entry to 6 weeks posrt-partum)
研究者
Hendree E. Jones
Adjunct Professor
Johns Hopkins University
研究点 (2)
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