Optimizing Open Label Placebo Rationales

Lifespan

Status: Completed

Conditions: Chronic Pain

Treatments: Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05952960

196178

Details and patient eligibility

About

A 3-arm randomized trial where all chronic pain patients will receive honest placebos, but the information about the placebos will differ between conditions. Outcomes are measured for 21 days and a qualitative survey will be conducted.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic pain
• 18 years old
• English speaking
• have a smartphone or computer with video access
• Taking prescription opioids for chronic pain
• the chronic pain is concentrated into the patient's lower back.

Exclusion criteria

• suspect an allergy to any placebo ingredient
• problematic substance use
• cancer diagnosis causing pain
• anticipated change in opioid script during the study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 3 patient groups

TAU Rationale

Other group

Description:

Rationale based on prior OLP studies (e.g. Kaptchuk et al., 2010)

Treatment:

Other: Placebo

Mindfulness Rationale

Other group

Description:

Rationale based on mindfulness meditation

Treatment:

Other: Placebo

Suspension of Disbelief Rationale

Other group

Description:

Rationale based on suspending disbelief about the placebo

Treatment:

Other: Placebo