NCT05883540招募中2 期
Lysergic Acid Diethylamide (LSD) in Palliative Care: a Randomised, Double-blind, Active-placebo Controlled Phase II Study (LPC-Study)
University Hospital, Basel, Switzerland7 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo
研究概览
简要总结
Background: Terminally ill patients often experience significant psychosocial distress having depressed mood, death anxiety, pain, and an overall poor quality of life. Recent evidence from pilot studies suggests that serotonergic hallucinogens including lysergic acid diethylamide (LSD) and psilocybin produce significant and sustained reductions of depressive symptoms and anxiety, along with increases in quality of life, and life meaning in patients suffering from life-threatening diseases. Additionally, serotonergic hallucinogens may produce antinociceptive effects.
Objective and Design: The study aims to evaluate effects of LSD on psychosocial distress in 60 patients suffering from an advanced or end-stage fatal disease with a life expectancy ≥12wks and ≤2yrs in an active placebo-controlled double-blind parallel study. Patients will be allocated in a 2:1 ratio to one of the two intervention arms receiving either two moderate to high doses of LSD (100 µg and 100 µg or 100 µg and 200 µg) as intervention and two low doses of LSD (25 µg and 25 µg) as active-placebo control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 22 years.
- •Advanced or End-stage fatal disease of any cause with a life expectancy ≥ 12 weeks and ≤ 2 years
- •Sufficient understanding of the study procedures and risks associated with the study.
- •Participants must be willing to adhere to the study procedures and sign the consent form.
- •Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after LSD administration.
- •Participants must complete an actual "Emergency Medical Directive"
- •Participants with central nervous system (CNS) involvement of cancer are eligible if the following apply:
- •treated and stable CNS lesion(s) OR untreated but asymptomatic/stable lesions, defined as clinically and/or radiologically stable for ≥ 4 weeks before screening
- •no seizures within ≥ 4 weeks; if on antiepileptic medication: stable dose ≥ 4 weeks and no relevant drug-drug interactions expected
- •no requirement for high-dose corticosteroids, defined as ≤10 mg prednisone equivalent per day on a stable or decreasing dose
- •no leptomeningeal metastases
- •no concomitant therapeutic anticoagulation
排除标准
- •Life expectancy < 12 weeks
- •Known hypersensitivity to LSD
- •Requiring ongoing concomitant therapy with a psychoactive prescription drug which might interfere with the study drug, and unable or unwilling to comply with the washout period.
- •Current use of a potent drug CYP2D6 inhibitor
- •Women who are pregnant or nursing or intend to become pregnant during the course of the study.
- •Somatic disorders including CNS involvement of cancer, untreated epilepsy with a history of generalized grand-mal seizures, history of delirium, end-stage heart failure (NYHA IV), untreated hypertension or insufficiently treated hypertension, angina pectoris, severe liver disease or severely impaired renal function, or other that in the judgement of the investigators pose too great potential for side effects.
- •Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant.
- •Participation in another study with an investigational drug within the 30 days preceding and during the present study
- •concomitant diagnosis of past or present psychotic disorder, first-degree relative with psychotic disorders
- •concomitant diagnosis of past or present bipolar disorder
- •current delirium
- •substance use disorder (within the last 2 months, except nicotine, opioids used for analgesia, and benzodiazepine treatment for anxiety).
- •Weight < 45 kg
- •Suicidal ideation with active intent or plan to act on suicidal thoughts as assessed by the treating investigator.
- •CNS involvement of cancer if
- •CNS disease is unstable or high-risk, including clinically and/or radiologically progressive lesions, signs of raised intracranial pressure, radiologically uncontrolled edema, need for escalating corticosteroid doses, or any neurological condition judged to pose too excessive risk.
- •CNS-directed therapy (surgery and/or radiation) within ≤ 4 weeks
研究组 & 干预措施
treatment arm
Experimental
Subjects in the treatment arm will receive 100 μg LSD (first session) and 100 or 200 μg LSD (second session) per os.
干预措施: Lysergic Acid Diethylamide Tartrate (Drug)
control arm
Active Comparator
Subjects in the control arm will receive 25 μg LSD (first session) and 25 μg LSD (second session) per os.
干预措施: Lysergic Acid Diethylamide Tartrate (Drug)
结局指标
主要结局
Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo
时间窗: baseline, 2 weeks after second intervention
State anxiety inventory (STAI-S) scores, 20 items
次要结局
- Changes in pain levels assessed by questionnaire compared with active placebo(baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention)
- Changes in spiritual well-being assessed by questionnaires (Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; The 12-item Spiritual Well-Being Scale (FACIT-Sp-12)) compared with active placebo(baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention)
- Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo(baseline, 2 days after each intervention, 4 weeks, 6 weeks, and 9 weeks after second intervention)
- Changes in opioid use (dosages of opioids unified according to equivalent dosages of oral morphine) compared with active placebo(concomitant medication will be assessed several times over whole study duration up to 9 weeks after second intervention)
- Changes in demoralization assessed by questionnaires (Demoralization Scale II (DS-II)) compared with active placebo(baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention)
- Changes in anxiety, pain levels, quality of life, demoralization, and spiritual well-being shortly after first intervention compared with scores shortly after second intervention(post drug visit 1-3 compared with post drug visit 4-6)
- Expectancy as a mediator for treatment effects assessed with questionnaire(baseline)
- Changes in patient's behaviour and attitudes rated by community observers compared with active placebo(baseline, before second intervention and 2 weeks and 9 weeks after second intervention)
- Changes in caregiver burden assessed by questionnaire compared with active placebo(baseline, before second intervention and 2 weeks and 9 weeks after second intervention)
- Changes in quality of life assessed with a single-item question compared with active placebo(baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention)
- Changes in patient's depression, isolation, anxiety, fear and denial of imminence of death, and pre-occupation with pain using investigator-ratings compared with active placebo(baseline, one day before second intervention and 2 and 9 weeks after second intervention)
- Changes in burden of suffering assessed with the Pictorial Representation of Illness and Self-Measure (PRISM) compared with active placebo(baseline, 2 days after each intervention, 2 weeks and 9 weeks after the second intervention)
- Qualitative description of subjective changes after intervention assessed with semistructured interviews(baseline, 2 days after each intervention, 2 weeks and 9 weeks after second intervention)
- Assessment of adverse events (AE)(during the whole study duration up to 9 weeks after second intervention)
- Physical and general discomfort during drug sessions using standardized questions (adapted list of complaints)(before and 12 hours after drug administration)
- Associations between acute LSD effects assessed with questionnaires and long-lasting therapeutic effects assessed with questionnaires(2,4,6, and 9 weeks after second intervention)
- Changes in vital signs during drug sessions(before and up to 12 hours after drug administration)
研究者
研究点 (7)
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