Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Heroin Craving
研究概览
简要总结
The purpose of this study is to evaluate whether prednisolone lowers intensity and frequency of craving in heroin-addicted subjects undertaking a detoxification of cocaine and/or heroin.
详细描述
Participants of this study are 120 heroin-addicted patients who are inward for a detoxification program for either cocaine or cocaine and heroin. Depending on the detoxification substance(s) there will be two groups of participants: Detoxification of cocaine (A; 60 participants) and detoxification of heroin and cocaine (B; 60 participants). The detoxification starts mandatory with the admission to the ward and lasts about 1-2 weeks. The participation in the study lasts about 4-5 weeks (including follow-up visits). Intake of study medication starts two days after admission and one day after informed consent. Each participant will get either 30mg/d prednisolon or placebo during five days. Participants will be under normal medical supervision during the treatment phase until follow-up 2 (final examination) provided by ward staff. Treatment days and follow-up 1 and 2 consist of : (1) vital signs (BP, HR, temperature) as measured in the daily routine, (2) at midday: visual analogue scales asking about craving for heroin and cocaine at the moment, (3) afternoon: questionnaires to survey mainly the withdrawal symptoms and vegetative parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature,
- •Group A Detoxification of stimulants (cocaine, amphetamine and/or methamphetamine); ICD-10: F14.2 and/or F15.2) OR Stable opioid dependency (no parallel consumption). Detoxifica-tion of stimulants.
- •Group B Opioid dependency and dependency of stimulants (cocaine, amphetamine and/or methamphetamine) and Detoxification of parallel consumption of stimulants and heroin (ICD-10: F11.2, 14.2, 15.2)
- •admission for detoxification to ward U2 of the University Psychiatric Hospital of Basel
排除标准
- •contraindications to the class of drugs under study or to any of the excipients, e.g. known hypersensitivity or allergy to class of drugs or the investigational product;
- •acute or severe co-morbid psychiatric disturbances (such as a heavy episode of major depression with suicidal ideations, acute exacerbation of a bipolar disorder, acute exacerbation of schizophrenia, alcohol addiction with an acute relapse, psychosis, dementia);
- •current medical conditions excluding participation (such as acute infectious disease, moni-tored by elevated CRP, diabetes mellitus, anticoagulation therapy);
- •recent history of systemic or topic glucocorticoid therapy;
- •alcohol intake > 0.0 ‰ according to breathalyser test on day 0 (screening) to exclude severe alcohol abuse;
- •specific drugs not allowed during the study or for specific periods of time prior to the administration of the test dose: Anticoagulant agents, antidiabetic agents, cyclosporine;
- •women who are pregnant or breast feeding;
- •intention to become pregnant during the course of the study;
- •inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia;
- •participation in another study with investigational drug within the 30 days preceding or during the present study;
- •previous enrolment into the current study;
- •enrolment of the investigator, his/her family members, employees and other dependent persons.
研究组 & 干预措施
Prednisolon
Participants will receive an oral administration of prednisolone or placebo two times daily for the first five days of opioid detoxification, starting after one day of regular detoxification as baseline. Oral prednisolone will be administered in a dose consistent with standard treatment guidelines for glucocorticoid deficiency (Oelkers, 1996).
干预措施: Prednisolone (Drug)
Placebo
Identical looking capsules like the IMP containing placebo (without active component) for oral administration.
干预措施: Placebo (for Prednisolone) (Drug)
结局指标
主要结局
Heroin Craving
时间窗: Assessing change between baseline and some predefined time points during 2 weeks
Visual Analogue Scale Craving
Cocaine Craving
时间窗: Assessing change between baseline and some predefined time points during 2 weeks
Visual Analogue Scale Craving
次要结局
- Withdrawal Symptoms according to ICD-10 (F14.3 and F12.2)(Assessing change between baseline and some predefined time points during 2 weeks)
- Questionnaire 'Health State'(Assessing change between baseline and some predefined time points during 2 weeks)
- Questionnaire 'Anger/Irritation'(Assessing change between baseline and some predefined time points during 2 weeks)
- Questionnaire 'Anxiety'(Assessing change between baseline and some predefined time points during 2 weeks)
- Saliva Cortisol levels(Assessing change between baseline and some predefined time points during 2 weeks)
研究者
Prof. Dominique de Quervain, MD
Director Division Cognitive Neuroscience
University of Basel