2024-519652-90-01招募中2 期
Pilot study on the safety and feasibility of intravenous opioid agonist therapy (OAT) with Hydagelan® (hydromorphone hydrochloride) in Vienna.
Suchthilfe Wien gGmbH1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月17日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- - Reduction of intravenous opioid use outside the medical setting. - Feasibility of implementation and execution
研究概览
简要总结
The objective is to determine whether
- intravenous opioid agonist therapy with hydromorphone can be integrated into clinical practice and is safe in this therapeutic setting.
- to include further target groups that have not yet been reached or have been reached only poorly.
- the offer of intravenous OAT is accepted by patients and staff of the Suchthilfe Vienna gGmbH.
- the intravenous consumption of "illegal" opioids or opioid-containing medications prescribed for oral use is reduced.
- the general state of health (somatic/psychological) and the social situation stabilize.
- a decrease in delinquency is recorded.
- a higher retention rate in treatment can be achieved.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age between 20 and 65 years - Opioid dependence according to ICD-10 diagnostic criteria. - Patient has been on opioid agonist therapy (OAT) for at least one year; otherwise has been on intravenous opioid use for at least one year; - Patients inject at least 5 times per week. - Presence of a consumption pattern that corresponds with the opening hours of the Suchthilfe Wien - Patient demonstrates willingness and ability to adhere to the planned study procedure and schedule. - Signed patient information after informed consent has been given - no planned vacations (more than 1 day per week), surgeries, hospital or prison stays within the next 14 weeks
排除标准
- •Diagnosis of severe medical or psychiatric illnesses - Pregnancy - Evidence of severe comorbidities with a predicted life expectancy of less than 12 months - Hypersensitivity to hydromorphone or any of the following other ingredients: Sodium chloride, sodium citrate, citric acid monohydrate, water for injections. - Presence of the following contraindications: o severe respiratory depression with hypoxia or elevated carbon dioxide levels in the blood (hypercapnia). o severe chronic obstructive airway disease o Cor pulmonale o Acute abdomen o Paralytic ileus o concomitant administration of monoaminooxidase inhibitors or within 2 weeks of their discontinuation
结局指标
主要结局
- Reduction of intravenous opioid use outside the medical setting. - Feasibility of implementation and execution
- Reduction of intravenous opioid use outside the medical setting. - Feasibility of implementation and execution
次要结局
- - Reduction in co-drug use - Safety of the intervention - Improvement in health status - Retention in treatment
研究者
Stephanie Wörter
Scientific
Suchthilfe Wien gGmbH
研究点 (1)
Loading locations...
相似试验
招募中
3 期
SMILe: Spinal Morphine or Intravenous Lidocaine in robot-assisted upper urologic surgery2023-505941-21-00Region Oestergoetland220
招募中
4 期
Methadone for post-operative pain reduction in heart surgery2024-519224-24-00Rigshospitalet220
已完成
4 期
Perioperative methadone compared to placebo in elderly hip fracture patients – a randomized controlled trial.
Phase two of the MetaHip trial2023-506252-24-00Sygehus Soenderjylland Soenderborg130
招募中
4 期
Midazolam and morphine to alleviate symptoms at the end of life in patients on acute geriatric wards2024-517763-22-00UZ Leuven300
招募中
2 期
Analgesic effect of intravenous lidocaïne and its mechanisms in patients suffering from chronic inflammatory bowel disease (IBD) with abdominal pain.2023-508224-35-01CHU De Liege80