Sex Differences and Progesterone: Association With Impulsivity and Marijuana Reduction in Co-Users of Marijuana and Nicotine Cigarettes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in Marijuana Use as Defined by the TLFB
研究概览
简要总结
The purpose of this study is to examine the role of progesterone (a naturally occurring hormone found in both men and women) on reducing marijuana use. The investigators will see if progesterone effects impulsivity, withdrawal, mood and stress during marijuana cessation.
详细描述
This double-blind, randomized pilot clinical trial will prescreen an estimated 250 potential subjects, consent and further evaluate approximately 100 potential subjects, and ultimately enroll 70 subjects to ensure 40 subjects will provide a primary marijuana reduction outcome measure at four weeks post quit date. Subjects will be stratified by sex then randomized to one of two treatment groups (n=20 per drug group, 50% female): progesterone (PRO; 200mg 2x/day) or Placebo (PBO). Telephone screening and visit invitation (20 minutes) leads to the consent process and in-person screening including medical-psychiatric evaluation for inclusion/exclusion (two visits, two hours each), then randomization and medication start (7 days), then stable medication (28 days) with medication reduction and final evaluation (7 days).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males 18-60 years old, females 18-50 years old
- •Stable physical and mental health
- •Self-report Timeline Follow-Back (TLFB) indicating current marijuana use ≥4 days/week for ≥1 year
- •Positive urine THC dipstick test (> 50ng/mL; indicating marijuana use in the past 48-72 hours)
- •Motivated to change their marijuana use (>1 on a 10-point Likert-type scale) -Regular or sporadic use of nicotine cigarettes (> 1 cigarettes in the past 30 days) -Self-report of regular menstrual cycles >6 months (female only)
- •Willing to use double-barrier contraception if sexually active and not surgically sterilized (female only)
- •Ability to comply with study procedures, ability to provide informed consent.
排除标准
- •Current breastfeeding (females only),
- •Current or planned pregnancy within the next three months (females only)
- •DSM-IV diagnoses for psychotic disorders, bipolar disorder, ADHD, major depressive disorder within the last 3 months
- •Substance dependence within the last 3 months with the exception of nicotine and marijuana dependence
- •Unstable psychotropic medications (<3 months)
- •Current use of exogenous hormones, finasteroid (propecia), efavirenz, red clover, ketoconazole and other drugs that are CYP3A4 inhibitors
- •Conditions contraindicated to progesterone treatment (including, but not limited to, thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes, history of stroke, allergy to peanuts, hypersensitive to progesterone and liver dysfunction)
研究组 & 干预措施
Males - Progesterone
200 mg progesterone BID
干预措施: Progesterone (Drug)
Males - Placebo
placebo BID
干预措施: placebo (Drug)
Females - Progesterone
200 mg progesterone BID
干预措施: Progesterone (Drug)
Females - Placebo
placebo BID
干预措施: placebo (Drug)
结局指标
主要结局
Change in Marijuana Use as Defined by the TLFB
时间窗: 5 weeks. Baseline to week 4
Marijuana use as defined by the TLFB at the week 4 visit relative to the baseline visit.
次要结局
未报告次要终点