Sex Differences & Progesterone: Association With Impulsivity and Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Week 4
研究概览
简要总结
Data suggest that progesterone may improve smoking cessation outcomes perhaps by reducing impulsive behavior. However, the clinical literature on this topic is lacking. Therefore, in Project I we are proposing a double-blind randomized controlled trial to assess the role of exogenous progesterone on impulsivity and smoking cessation in a sample of males and females who are motivated to quit smoking.
详细描述
Subjects will be stratified by sex and then randomly assigned to active progesterone (PRO) or placebo (PBO).
Telephone screening and visit invitation leads to the consent process and in-person screening including medical-psychiatric evaluation for inclusion/exclusion, then randomization and medication induction, stable medication with medication reduction and final evaluation for secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male 18 to 60 years old
- •Female 18 to 50 years old
- •Self-report regular smoking
- •Motivated to quit smoking
- •In stable physical/mental health
- •Self report of regular menstrual cycles (female only)
- •English fluency
- •Understand the study procedures and able to provide informed consent
- •Ability to participate fully in research elements for the duration of the trial.
排除标准
- •Current or recent (< 3 months) breastfeeding (females only)
- •Current or planned pregnancy within the next three months (females only)
- •Conditions contraindicated to progesterone treatment.
研究组 & 干预措施
Placebo
Placebo - subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
干预措施: Placebo (Other)
Placebo
Placebo - subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
干预措施: Smoking Cessation Behavioral Counseling (Other)
Progesterone
The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
干预措施: Progesterone (Drug)
Progesterone
The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily, orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date. They will also receive smoking cessation behavioral counseling.
干预措施: Smoking Cessation Behavioral Counseling (Other)
结局指标
主要结局
Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Week 4
时间窗: Week 4
7-day point prevalence abstinence from smoking defined as having no slips (i.e., a puff or more from a lit cigarette) in the seven days prior to week 4
次要结局
- Number of Participants With Continuous Abstinence From Smoking at Week 12(Week 12)
- Average Number of Days to Relapse(Days 1 through 84)
- Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Weeks 8 and 12(Weeks 8 and 12)
- Number of Participants With Cotinine <50 ng/mL at Weeks 4, 8 and 12(Weeks 4, 8 and 12)
- Number of Participants With Prolonged Abstinence From Smoking at Weeks 4, 8 and 12(Weeks 4, 8 and 12)
- Number of Participants With Breath Carbon Monoxide ≤5 Ppm at Weeks 4, 8 and 12(Weeks 4, 8 and 12)