Phase III Study of Maintenance Treatment for Opiate Dependence With Heroin (Diamorphine) Compared to Methadone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,015
- 试验地点
- 7
- 主要终点
- (A) Improvement of physical or mental state of health,
研究概览
简要总结
The study will test the hypotheses that heroin assisted treatment, compared to methadone maintenance treatment, is more effective with regard to
- the improvement of health,
- reduction of illicit drug consumption,
- decrease of criminal behaviour,
- rise in the accessibility and retainment,
- detachment from a social drug context,
- social stabilisation in the sense of new drug-free contacts, improved vocational circumstances, financial security, stabilisation of the living situation,
- enrollment in subsequent treatment in the case of heroin dependent persons who could not be effectively reached or successfully treated so far, and it will check which is the optimal treatment setting with regard to these aims.
The medication is injectable pure heroin (diacetylmorphine) 3x/d, or d l methadone 1x/d
The study design is multicentre, open, randomised, 4 x 2 stratified. The study duration is 24 months (individual period of investigation), 1. study phase: 12 moths (protocol part B) and 2. study phase: 12 moths (part C). Patients recruited have an opiate dependency according to ICD-10, who are not being treated currently or who are in a methadone maintenance programme with an unsatisfactory course of treatment.
详细描述
Detailed description of study phase 1 (randomized, controlled part of study) only.
Part B - Study phase 1 B1.1 Clinical hypothesis Compared to maintenance with oral methadone, heroin treatment leads to
- significant improvement of the physical and/or mental state of health,
- greater reduction of illicit drug use and therefore greater detachment from the drug scene,
- significant improvement of the social situation,
- higher retention rate or attachment to treatment, in the case of those heroin dependent persons who could not be effectively reached or could not sufficiently profit from methadone maintenance programmes.
B1.2 Primary outcome criteria
- Improvement of the physical and mental state of health (A) AND
- Reduction of illicit heroin use and non-increase of cocaine use (B). B1.3 Secondary outcome criteria
- Retention rate
- Reduction of benzodiazepine, amphetamine, alcohol and other drug use
- Reduction of scene contacts / of contacts to other drug consumers
- Decrease of delinquent behaviour
- Stabilisation of housing situation
- Establishment of new social contacts
- Improvement of quality of life
- Mortality rate. B2. STUDY DESIGN Phase 1 of the clinical trial consists in a 4 x 2-branched randomised multicentre study. The sample is stratified and consists on the one hand of heroin dependent persons in methadone maintenance treatment that do not sufficiently profit from treatment (MS), and on the other hand of heroin dependent persons who are currently not being treated for their addiction (NE). Patients of both target groups who meet the admission criteria will be randomised to four arms: experimental groups (MS-E-C) and (NE-E-C): heroin treatment with concurrent case management, experimental groups (MS-E-P) and (NE-E-P): heroin treatment with concurrent psychoeducation/drug counseling and control groups (MS-K-C) and (NE-K-C): methadone treatment with concurrent case management, control groups (MS-K-P) and (NE-K-P): methadone treatment with concurrent psychoeducation/drug counseling.
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
- None
入排标准
- 年龄范围
- 23 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum age 23 years
- •Opiate dependency for at least 5 years
- •Current main diagnosis of opiate dependency according to the ICD-10 criteria
- •Current daily and predominantly intravenous heroin consumption or continuing heroin consumption in maintenance treatment
- •Symptoms of physical illness indicating a poor state of health according to the OTI health scale; at least 13 current symptoms must be found OR Current mental symptoms or disturbances, i.e. a standardised GSI value of the SCL-90-R (Franke 1995) of at least 60 points
- •No participation in an addiction treatment programme (a.a. maintenance, inpatient or outpatient treatment) at least within the last 6 months, but documented previous experience with drug therapies OR Negative course of maintenance treatment according to the guidelines of the German Medi¬cal Council (Bundesärztekam¬mer 1997) due to (a) continuous additional consumption of heroin (50% of the urine samples positive within the last 6 months) or cocaine (harmful use of cocaine/crack according to ICD-10) in a documented maintenance period of at least 6 months with a current maintenance dose of at least 60 mg d l methadone (or 30 mg levo¬methadone) daily
- •Residence or registration in the city (or city state) or region that conducts the heroin treat¬ment for at least 12 months
- •Voluntary participation and ability to comply with the treatment conditions (willingness to change treatment location; compliance; treatment control/documentation; evalua¬tion)
- •Written consent to comply with the treatment conditions.
排除标准
- •Persons who are currently in prison or awaiting trial or who can be expected to be taken into custody within the next 3 months
- •Persons who had voluntary phases of abstinence of at least 2 months during the last 12 months
- •Known epilepsy or generalised convulsions during the last 12 months
- •Hypersensitivity to test substances and additives
- •Regular intake of MAO inhibitors
- •Serious bronchial asthma, COPD, Cor pulmonale
- •Serious cardiac arrhythmia
- •Prostatic hypertrophy (with urinary retention)
- •Urethral stricture
- •Life threatening liver disorders (exogenous hepatic coma)
- •Serious renal disorders
- •Insulin dependent diabetes mellitus
- •Diagnosed malignancies during the last 6 months
- •Pregnant women or nursing mothers
- •Patients, who, according to the study physician's judgement, are not able to comply with the conditions of the model project, i.e. participation in the therapeutic and scientific pro¬grammes, due to serious physical or mental illness
- •Patients who are currently participating in another clinical study concerned with the evalua¬tion of an addiction treatment programme.
研究组 & 干预措施
MTF, Psycho-education, Heroin
Stratum: Methadone treatment failures (MTF) Intervention: Psycho-education and Counselling, Drug: Diacetylmorphine (i.v.)
干预措施: Diacetylmorphine (Drug)
MTF, Psycho-education, Heroin
Stratum: Methadone treatment failures (MTF) Intervention: Psycho-education and Counselling, Drug: Diacetylmorphine (i.v.)
干预措施: Psycho-education and Counselling (Behavioral)
MTF, Case management, Heroin
Stratum: Methadone treatment failures (MTF) Intervention: Case Management and Motivational Interviewing, Drug: Diacetylmorphine (i.v.)
干预措施: Diacetylmorphine (Drug)
MTF, Case management, Heroin
Stratum: Methadone treatment failures (MTF) Intervention: Case Management and Motivational Interviewing, Drug: Diacetylmorphine (i.v.)
干预措施: Case management and Motivational interviewing (Behavioral)
MTF, Psycho-education, Methadone
Stratum: Methadone treatment failures (MTF) Intervention: Psycho-education and Counselling, Drug: Methadone (p.o.)
干预措施: Psycho-education and Counselling (Behavioral)
MTF, Psycho-education, Methadone
Stratum: Methadone treatment failures (MTF) Intervention: Psycho-education and Counselling, Drug: Methadone (p.o.)
干预措施: Methadone (Drug)
MTF, Case management, Methadone
Stratum: Methadone treatment failures (MTF) Intervention: Case Management and Motivational Interviewing, Drug: Methadone (p.o.)
干预措施: Methadone (Drug)
MTF, Case management, Methadone
Stratum: Methadone treatment failures (MTF) Intervention: Case Management and Motivational Interviewing, Drug: Methadone (p.o.)
干预措施: Case management and Motivational interviewing (Behavioral)
NIT, Psycho-education, Heroin
Stratum: Not in treatment (NIT) Intervention: Psycho-education and Counselling, Drug: Diacetylmorphine (i.v.)
干预措施: Diacetylmorphine (Drug)
NIT, Psycho-education, Heroin
Stratum: Not in treatment (NIT) Intervention: Psycho-education and Counselling, Drug: Diacetylmorphine (i.v.)
干预措施: Psycho-education and Counselling (Behavioral)
NIT, Case management, Heroin
Stratum: Not in treatment (NIT) Intervention: Case Management and Motivational Interviewing, Drug: Diacetylmorphine (i.v.)
干预措施: Diacetylmorphine (Drug)
NIT, Case management, Heroin
Stratum: Not in treatment (NIT) Intervention: Case Management and Motivational Interviewing, Drug: Diacetylmorphine (i.v.)
干预措施: Case management and Motivational interviewing (Behavioral)
NIT, Psycho-education, Methadone
Stratum: Not in treatment (NIT) Intervention: Psycho-education and Counselling, Drug: Methadone (p.o.)
干预措施: Psycho-education and Counselling (Behavioral)
NIT, Psycho-education, Methadone
Stratum: Not in treatment (NIT) Intervention: Psycho-education and Counselling, Drug: Methadone (p.o.)
干预措施: Methadone (Drug)
NIT, Case management, Methadone
Stratum: Not in treatment (NIT) Intervention: Case Management and Motivational Interviewing, Drug: Methadone (p.o.)
干预措施: Methadone (Drug)
NIT, Case management, Methadone
Stratum: Not in treatment (NIT) Intervention: Case Management and Motivational Interviewing, Drug: Methadone (p.o.)
干预措施: Case management and Motivational interviewing (Behavioral)
结局指标
主要结局
(A) Improvement of physical or mental state of health,
时间窗: 12 months
(B) Reduction of consumption of street heroin and no increase of cocaine use.
时间窗: 12 months
次要结局
- Retention rate(12 months)
- Detachment from the drug scene(12 months)
- Establishment of new social contacts(12 months)
- Improvement of quality of life(12 months)
- Mortality rate(12 months)
- Reduction of consumption of, benzodiazepines, amphetamine, alcohol and other substances(12 months)
- Decrease of criminal behaviour(12 months)
- Stabilisation of the living situation(12 months)
研究者
PD Dr. Uwe Verthein
Director of Centre for Interdisciplinary Addiction Research
Universitätsklinikum Hamburg-Eppendorf