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Are pills enough? The influence of information on open-label placebo effects in healthy volunteers

Open-label placebo administration, treatment information, and wellbeing in healthy participants

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001092381
Enrollment
108
Registered
2017-07-27
Start date
2017-08-01
Completion date
2018-05-07
Last updated
2018-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will investigate the role of information provision in open-label placebo administration. Recent studies have found that open-label placebo treatments are effective in improving symptoms of IBS, depression, ADHD, and low-back and migraine pain. These findings suggest the possibility of generating a placebo effect without deception. Participants will be recruited to take part in a study investigating the effect of open-label placebo administration on wellbeing and randomly assigned to one of three conditions: no-treatment control, standard RCT placebo information, or enhanced open-label placebo information.

Interventions

Open-label placebo administration (1 placebo pill per day, with either standard RCT placebo information versus enhanced open-label placebo information) for 5 days compared to a no treatment control condition. Adherence will be assessed via self-report at follow-up after completion of the course of placebo pills (day 6). Enhanced information will follow the talking points outlined by Kaptchuk and colleagues (2010) - namely that placebos are powerful, can produce an automatic healing response, th

Open-label placebo administration (1 placebo pill per day, with either standard RCT placebo information versus enhanced open-label placebo information) for 5 days compared to a no treatment control condition. Adherence will be assessed via self-report at follow-up after completion of the course of placebo pills (day 6). Enhanced information will follow the talking points outlined by Kaptchuk and colleagues (2010) - namely that placebos are powerful, can produce an automatic healing response, that positive expectations are not necessary but keeping an open mind is important, and that taking pills faithfully (i.e. adherence) is critical. Standard RCT information is similar to that typically provided in RCT studies involving a placebo control condition. Namely, placebos will be described as typically being used as a control treatment, with the capsules containing inert ingredients that have no active physiological effect. Information will be provided verbally to both groups during an initial half hour face-to-face research session. Information provision will take 5 to 10 minutes. At the end of this session, participants will be given lactose-filled vegetarian gelatin placebo capsules to take for the next 5 days.

Sponsors

Dr Kate Faasse
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Participants will be healthy undergraduate students

Exclusion criteria

Lactose intolerance

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026