RecruitingACTRN12621001150831

How Does Choice Influence Drug Response?

How Does Choice Influence Side Effect Reporting in Response to an Inert Medication in Healthy Adults?


Sponsor

University of Auckland

Enrollment

82 participants

Start Date

Aug 4, 2021

Study Type

Interventional

Conditions

Summary

Previous research has shown that reducing choice both leads to higher levels of nocebo responding and diminishes the placebo effect (Bartley, Faasse, Horne & Petrie, 2016). This study seeks to explore the mechanisms through which this process occurs. One possibility is that reducing choice focuses attention on negative information about medication. In a study where participants are randomised to either get a choice of medication or not, we investigate whether a lack of choice increases focus and recall of negative information about a medication. As the medication in this research will be a placebo, reported side effects will be nocebo effects (the reported side effects from an inert agent) and reported medication efficacy will be placebo effects. Hypothesis 1: Providing participants with a choice in medication will result in fewer nocebo effects and greater placebo response than participants who have been given no choice of medication (replication of Bartley et al. 2016). Hypothesis 2: The no choice group will show a greater recall of negative information supplied about the medication.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When patients are prescribed medication, having a choice in which medication they take — even between two identical options — can influence how they experience that medication. Previous research has suggested that removing choice leads to more 'nocebo effects', meaning patients report more side effects even from inert (dummy) pills. This study is exploring why this happens. Participants will be randomly assigned to either choose their medication from a selection, or simply be assigned one. All participants will actually receive a placebo (an inert pill), but will be told information about potential side effects of a beta blocker. The study will look at whether the group without choice recalls more of the negative information they were given, and whether they report more side effects as a result. You are eligible if you are 18 or older and a fluent English speaker. The study is not suitable for people currently taking beta blockers or certain heart medications, or those with heart, breathing, or blood sugar conditions where taking a beta blocker would be contraindicated. This is important because participants are asked to genuinely believe they might be taking a beta blocker for the study to work.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Previous research has shown that reducing patient choice both leads to higher levels of nocebo responding and diminishes the placebo effect (Bartley et al., 2016). This study seeks to explore the mech

Previous research has shown that reducing patient choice both leads to higher levels of nocebo responding and diminishes the placebo effect (Bartley et al., 2016). This study seeks to explore the mechanisms through which this process occurs. One possibility is that reducing choice focuses attention to negative information about the medication. This study will investigate whether limiting choice will increase recall of negative information and influence both placebo and nocebo responding. As the medication in this research will be a placebo, reported side effects will be nocebo effects (the negative side effects of an inert agent) and reported medication efficacy will be placebo effects. The placebo itself comprises a capsule containing lactose monohydrate, microcrystalline cellulose and magnesium stearate, and will be administered orally at a single time point during the intervention session. Participation will involve randomisation to either a choice group (in which participants will select one of two “beta blockers” to take) or a no-choice group (participants will be led to believe that they will randomly receive one of the two beta blockers, when in actual fact, they will receive their non-preferred option). Participants will receive a beta blocker information brochure, which was designed specifically for this study and gives an overview of the mechanisms of beta blockers, their potential side effects, and how they may be useful for anxiety. After taking the placebo, participants will wait 10 minutes, and will be told that during this time period, the beta blocker should take effect. Immediately following this latent period, they will take part in 3 short tasks to simulate an examination setting (these include digit span, digit symbol matching, and a recall task). Heart rate and blood pressure measurements will be recorded at three time points throughout the session, along with questionnaires about anxiety and side effects. It is expected that the 3 exam-simulating tasks will take participants 15 minutes to complete. The overall session, including the completion of questionnaire and the repeated measurements of heart rate and blood pressure, will take 50 minutes total. The following day, participants will complete a brief follow-up questionnaire on anxiety and side effects experienced over the prior 24 hours. This will be sent via a link and completed online.


Locations(1)

Auckland, New Zealand

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ACTRN12621001150831