Conditioned Open-label Placebos to Facilitate the Reduction of Opioid Medication (ROM) in Patients With Chronic Non-cancer Pain: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Daily opioid consumption (MED):
研究概览
简要总结
This study aims to evaluate whether the reduction of the daily morphine equivalent dose (MED) in patients with chronic non-cancer pain (CNCP) can be decreased with an open-label placebo (OLP) intervention in comparison to an electronic monitoring (EM) control group. The participants will receive the intervention (OPL or EM) over the duration of six weeks. Diverse psychological and health measures will be assessed with questionnaires over the course of the intervention. Furthermore, evaluation outcomes, qualitative outcomes and safety outcomes will be assessed. It is hypothesized that the OLP-intervention group in comparison to the EM-control group will have a significantly lower consumption of MED over the course of the study. Furthermore, this study aims to evaluate whether the OLP intervention can reduce opioid withdrawal symptoms in comparison to the control group.
详细描述
CNCP is a major global health problem and is often treated with opiod medication, although risks outweigh the benefits. Therefore, recent studies suggest that an open-label placebo (OLP) treatment, the placebo treatment with full disclosure of being a placebo, has proven to be an effective, clinically relevant, and evidence-based treatment in CNCP syndromes. Furthermore, a new line of research indicated that OLPs have been shown to be feasible for the reduction of active medication in opioid use disorder. In line with the conditioning paradigm, the drug as the unconditioned stimulus is paired with the neutral stimulus of an OLP in a learning phase. Then, the OLP alone becomes a conditioned stimulus.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •≥ 18 years of age
- •German speaking
- •Chronic non-cancer pain ≥ 6 months in duration
- •Chronic opioid medication for > 3 months
- •Oral intake of opioid medication
- •Motivation for opioid reduction
- •Participants have a primary treating physician who performs the reduction of the opioid medication
- •Having access to a computer or tablet with an email-account
排除标准
- •Having psychotic symptoms
- •Suicidality
- •Cognitive impairment to everyday life
- •Planned surgery within the next two months
- •Known illegal drug or harmful alcohol consumption
- •Intolerance of the ingredients of the placebo pill (e.g., lactose, sucrose, corn-starch)
- •Serious health problems that make study participation impossible
- •Simultaneous participation in other studies with investigational drugs or CNCP specific interventions
研究组 & 干预措施
Open-Label Placebo
The intervention involves administering "P-Dragees blue Lichtenstein," blue placebo pills devoid of active ingredients. Each pill contains lactose monohydrate; magnesium stearate (Ph. Eur.); microcrystalline cellulose; sucrose; glucose syrup; corn-starch; highly dispersed silicon dioxide; white clay; macrogol glycerol hydroxy stearate (Ph. Eur.); Gum arabic; montanglycol wax; povidone (K 25); talcum; titanium dioxide (E 171); calcium carbonate; macrogol 6000; patent blue V; aluminium salt (E 131).
Participants will be informed that the pills are placebos and will be instructed to pair them with opioid medication for 7 days. After 7 days until the end of the study they will be instructed to continue to pair their opioid medication with an OLP pill and take additionally placebo pills on the basis of their need.
An evidence-based rationale will be provided, explaining why the placebo treatment is deemed effective for pain. This rationale will precede the OLP intake procedure.
干预措施: P-Dragees blue Lichtenstein, Placebo dragees (Other)
Electronic monitoring (EM) control group
EM is a method to objectively measure adherence and serves as the primary intervention component on the basis of which adherence trajectories will be discussed. The participants in the EM control group will receive an evidence-based rational designed to foster positive expectations and will be instructed on the mechanisms of EM.
The EM control group is structurally equivalent to the OLP group referring to the number and duration of contacts between participants and the study team members as well as to the format of the intervention and the quality of the interaction.
干预措施: Control group (EM) (Other)
结局指标
主要结局
Daily opioid consumption (MED):
时间窗: Daily measure: starts on day 1 after the first intervention visit (baseline, day 0) after randomization and ends on day 42 at the end of the study.
Cumulative dose (i.e. total amount) of opioid pain medication consumption based on daily morphine equivalent doses (MED). Data is collected in SEMA3 app.
次要结局
- Subjective opioid withdrawal symptoms(Measured three times: on day 0 at the first intervention visit (baseline), on day 7, and on day 42 at the end of the study.)
- Pain severity(Measured three times: on day 0 at the first intervention visit (baseline), on day 7, and at the end of the study on day 42.)
- Pain disability(Measured three times: on day 0 at the first intervention visit (baseline), on day 7, and at the end of the study on day 42.)
- Anxiety(Measured three times: on day 0 at the first intervention visit (baseline), on day 7, and at the end of the study on day 42.)
- Depression(Measured three times: on day 0 at the first intervention visit (baseline), on day 7, and at the end of the study on day 42.)
- Pain Opioid Analgesics Beliefs Scale - Cancer(Measured three times: on day 0 at the first intervention visit (baseline), on day 7, and at the end of the study on day 42.)
- Treatment Expectancy 2(One-time assessment: measured on day 0 at the first intervention visit (baseline).)
- Treatment Expectancy 1(One-time assessment: measured on day 0 at the first intervention visit (baseline).)
- Placebo pill count(Daily measure: starts 1 day after the first intervention visit (baseline, day 0) after randomization and ends on day 42 at the end of the study.)
- Opioid adherence(Daily measure: starts 1 day after the first intervention visit (baseline, day 0) after randomization and ends on day 42 at the end of the study.)
研究者
Cosima Locher
Principal Investigator
University of Zurich