NCT00900900已完成2 期
The Effects of One-Time Pregnenolone, DHEA, Or Placebo Administration On Withdrawal Symptoms, Mood, Craving And Cigarette Evaluation Ratings In Male Smokers
Jed E. Rose1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- The administration of DHEA or pregnenolone will reduce smoking withdrawal symptoms.
研究概览
简要总结
This study will evaluate the potential therapeutic value of two neurosteroid treatments (DHEA and pregnenolone) in the treatment of tobacco withdrawal symptoms. This will include assessing whether these agents relieve craving for cigarettes elicited by exposure to a mildly stressful cognitive task. Pregnenolone (400 mg orally), DHEA (400 mg orally) and placebo will be administered one at each of the three sessions in a randomized order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18-65 years old;
- •smoked an average of at least 10 cigarettes per day for three cumulative or continuous years of a brand that delivers (by Federal Trade Commission rated yields) at least 0.5 mg nicotine;
- •afternoon expired carbon monoxide reading of at least 10 ppm;
- •in general good health, based on physical examination, EKG serum chemistries, CBC and urinalysis.
排除标准
- •Participants must not have uncontrolled hypertension (systolic >140 mm Hg, diastolic >95 mm Hg)
- •hypotension (systolic <90 mm Hg, diastolic <60 mm Hg);
- •coronary heart disease;
- •heart attack;
- •cardiac rhythm disorder (irregular heart rhythm);
- •chest pains (unless history, exam, and EKG clearly indicate a non-cardiac source);
- •cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
- •liver or kidney disorder (except kidney stones, gallstones);
- •gastrointestinal problems or disease other than gastroesophageal reflux,
- •heartburn, or irritable bowel syndrome;
- •ulcers within the past 6 months;
- •lung disorder (including but not limited to COPD, emphysema, and asthma);
- •brain abnormality (including but not limited to, stroke, brain tumor, seizure disorder);
- •history of fainting;
- •problems giving blood samples;
- •current cancer or treatment for cancer in the past 6 months (except basal or squamous cell skin cancer);
- •other major medical condition;
- •major depression, panic disorder, anxiety, bipolar disorder, schizophrenia, risk of suicide, or substance dependence other than nicotine dependence;
- •subjects who endorse suicidal ideation on the MINI abridged;
- •alcohol or drugs abuse;
- •reported use of illicit drugs within the past 30 days, or if the drug screen is positive;
- •reported use of smokeless tobacco (chewing tobacco, snuff), cigars, pipes, or nicotine replacement therapy; testosterone replacement therapy, DHEA or Pregnenolone; experimental (investigational) drugs; psychiatric medications (including antidepressants, anti-anxiety agents. anti-psychotics), sleep aids, medications that increase DHEA and/or DHEA-S concentrations (including, but not limited to: diltiazem, benfluorex, amlodipine, alprazolam, danazol, metformin, nitrendipine and retinol), or any other medications that are known to affect smoking (e.g. clonidine, muscle relaxants, opiate pain medications) within the past 2 weeks.
研究组 & 干预措施
Dehydroepiandrosterone (DHEA)
Experimental
干预措施: dehydroepiandrosterone (DHEA) (Dietary Supplement)
Pregnenolone
Experimental
干预措施: pregnenolone (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The administration of DHEA or pregnenolone will reduce smoking withdrawal symptoms.
时间窗: 6 months
次要结局
- The administration of DHEA or pregnenolone will reduce the subjective rewarding effects of nicotine inhaled in cigarette smoke.(6 months)
- The administration of DHEA or pregnenolone will reduce stress-induced changes in mood and craving for cigarettes.(6 months)
研究者
Jed E. Rose
Professor Department of Psychiatry and Behavorial Sciences
Duke University
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Neurosteroids as Novel Therapeutic Agents for Chronic Pain in OEF/OIF VeteransLower Back PainNCT01898013Durham VA Medical Center94
已完成
2 期
Complementary Neurosteroid Intervention in Gulf War Illnesses (GWVI)FatigueMusculoskeletal PainCognitive DeclineNCT01956279VA Office of Research and Development170
招募中
2 期
Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIVAnxiety DepressionHIVMajor Depressive DisorderNCT05570812Massachusetts General Hospital120
终止
2 期
Neurosteroids in PTSD - Biomarkers to TherapeuticsPosttraumatic Stress DisorderNCT03491007VA Office of Research and Development5
已完成
3 期
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone Replacement for Primary Adrenal InsufficiencyAddison's DiseaseNCT00004313National Center for Research Resources (NCRR)40