NCT01741376撤回不适用
Progesterone and Atomoxetine for Cocaine Cessation
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Cocaine Cessation
研究概览
简要总结
The purpose of this study is to examine the role of progesterone (a hormone found in both men and women) on stopping cocaine use. The study will examine whether the medication, in combination with behavior therapy will decrease cocaine use, cigarette smoking, withdrawal symptoms, impulsivity and stress.
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
- 否
入选标准
- •Females between 18 and 45 and males between 18 and 60 years-of-age;
- •Understand the study procedures and provide written informed consent;
- •Meet DSM-IV criteria for cocaine or methamphetamine and nicotine dependence;
- •Minimum of cocaine use 4 days/months over last 3 months;
- •Minimum of 5 cigarettes/day for last twelve months;
- •Stable psychiatric status;
- •Stable medical status; Willing to use double-barrier contraception method if sexually active and not surgically sterilized;
- •Regular menstrual cycles (for females);
- •No contraindications to progesterone treatment;
- •Ability to participate fully in research elements for the duration of the trial.
排除标准
- •DSM-IV diagnoses for current or lifetime psychotic disorders (unless substance induced), bipolar disorder, current ADHD and other current substance dependence (except nicotine dependence, or alcohol or cannabis dependence not exhibiting withdrawal or other features requiring medical attention);
- •Currently using nicotine pharmacotherapy preparations;
- •history of thromboembolic events, diabetes, stroke, heart disease;
- •Psychotropic medications other than stable doses of anti-depressants;
- •Currently pregnant or nursing;
- •Liver enzyme levels three times normal limits;
- •Previous treatment with or adverse response to progesterone.
- •Serious suicide attempt within preceding 2 years;
- •Current use of exogenous hormones.
- •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).
- •History of pheochromotytoma or narrow angle glaucoma,
- •Current hypertension, tachycardia or clinically relevant ECG abnormalites;
- •Allergy to peanuts,
- •Current suicidality or need for emergency psychiatric treatment.
研究组 & 干预措施
Placebo + Placebo
Placebo Comparator
Two placebos are given for 84 days.
干预措施: Placebo (Drug)
Progesterone + Placebo
Active Comparator
Progesterone (200 mg twice daily) and a placebo are given
干预措施: Progesterone (Drug)
结局指标
主要结局
Cocaine Cessation
时间窗: Days 1 to 86
Urine Test
次要结局
- Impulsivity(Days 1 to 86)
研究者
研究点 (1)
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