Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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