Progesterone for Postpartum Cocaine Relapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean Number of Days Per Week of Cocaine Use
研究概览
简要总结
The investigators propose a placebo-controlled, randomized clinical trial that would enroll 50 postpartum women with a history of cocaine abuse or dependence to assess whether progesterone (100mgs twice daily) decreases postpartum cocaine use.
详细描述
Specific Aim 1: To evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo.
Hypothesis 1: Compared to women who are randomized to placebo, those assigned to progesterone will use less cocaine as measured by urine toxicology results and self-reported days of use.
Specific aim 2: To obtain information about the safety and tolerability of progesterone treatment in the postpartum period.
Hypothesis 2: Side effects for progesterone will be similar to those of placebo.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Gravidas (women who delivered a baby in the past 12 weeks) who are 18 or older are eligible to participate.
- •Women must meet diagnostic criteria for abuse or dependence of cocaine in the six-months prior to conception or during pregnancy.
- •Women who abuse other illicit substances or alcohol would also be eligible as long as cocaine was their primary drug of abuse. If women are also opiate dependent, they must be undergoing treatment with methadone or buprenorphine. While we propose to target cocaine we will also monitor the ability of women with polysubstance use to maintain abstinence from substances other than cocaine.
排除标准
- •Women will be ineligible for the trial if they:
- •have a history of major medical illnesses including liver diseases, suspected or known malignancy, thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes, history of stroke or other medical conditions that the physician investigator deems as contraindicated for participation in the study;
- •have a known allergy to progesterone or peanuts (vehicle for micronized progesterone);
- •speak a language other than English;
- •are planning on moving out of the area in the first six months after delivery;
- •are unable to understand the study or are unable to provide informed consent;
- •are currently undergoing treatment with another pharmacological agent for substance abuse treatment (with the exception of methadone or buprenorphine as above);
- •have pending incarceration;
- •are currently incarcerated;
- •are using another progestin;
- •are unwilling to accept randomization;
- •are unwilling to use a barrier method of birth control for the duration of the study to ensure that they will not become pregnant.
研究组 & 干预措施
Placebo
Matched placebo pills to be taken twice daily
干预措施: Placebo (Other)
Progesterone
100 mgs progesterone twice daily
干预措施: Progesterone (Drug)
结局指标
主要结局
Mean Number of Days Per Week of Cocaine Use
时间窗: Weekly measurements, Baseline to 12 weeks
Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week via substance use calendar.
Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up
时间窗: baseline, end of trial (week 12), 3-month post-trial follow-up
Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week during the trial period and during 3 month follow up using the substance use calendar
Proportion of Positive Urine Samples Per Week
时间窗: baseline, end of trial (week 12) and 3-month post-trial follow-up
Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.
次要结局
- Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group(12 weeks postpartum)
- Cocaine Craving (Measured Weekly Using CCQ-Brief)(baseline to 12 weeks)
- Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))(baseline to 12 weeks)
- Salivary Progesterone Concentrations(week 2, week 6, week 10, week 12)