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2420 Examining characteristics of placebo effects on trauma-related insomnia in a suvorexant trial
OBJECTIVES/SPECIFIC AIMS: The aims of this project are to: (1) examine placebo effects on subjective and objective outcome measures, (2) determine if an increase in the placebo is associated with changes in benefit, (3) evaluate if the trauma related insomnia placebo group in our study has different...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Cambridge University Press
2018
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6799138/ http://dx.doi.org/10.1017/cts.2018.167 |
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author | Uweh, Kimberly |
author_facet | Uweh, Kimberly |
author_sort | Uweh, Kimberly |
collection | PubMed |
description | OBJECTIVES/SPECIFIC AIMS: The aims of this project are to: (1) examine placebo effects on subjective and objective outcome measures, (2) determine if an increase in the placebo is associated with changes in benefit, (3) evaluate if the trauma related insomnia placebo group in our study has different side effect reports compared with insomnia placebo participants in previous suvorexant trials, and (4) (Exploratory) examine associations between the placebo group’s characteristics (e.g., trauma/PTSD severity, demographics) and placebo effects. METHODS/STUDY POPULATION: The parent study is a randomized double-blind placebo-controlled clinical trial (clinicaltrials.gov ID: NCT02704754) of suvorexant for treatment of adults (age 18–55) with insomnia that started or worsened after trauma exposure. Suvorexant is a first in class orexin antagonist and is approved by the FDA for the indication of insomnia. In this 6-week trial, all participants initially take 10 mg of suvorexant/placebo, and the dose will be increased to 20 mg if participants continue to experience clinically significant insomnia symptoms 1 week after starting the medication. Sleep outcomes will be measured by polysomnography, daily sleep diary, and the Insomnia Severity Index. RESULTS/ANTICIPATED RESULTS: We hypothesize that (1) within the placebo group data both subjectively and objectively measured outcomes will similarly show improvement in insomnia symptoms, (2) the increase of the placebo medication dose will result in an increased benefit, (3) the trauma-related insomnia placebo group will have the same type and similar rate of side effects reported in previous suvorexant trials. DISCUSSION/SIGNIFICANCE OF IMPACT: Most previous studies examining placebo effects focused on pain and depression. Information obtained from this project will complement our current understanding of placebo effects by characterizing placebo effects on trauma-related insomnia. This study will inform the development of novel strategies to maximize utility of placebos in future clinical trials. |
format | Online Article Text |
id | pubmed-6799138 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Cambridge University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-67991382019-10-28 2420 Examining characteristics of placebo effects on trauma-related insomnia in a suvorexant trial Uweh, Kimberly J Clin Transl Sci Basic/Translational Science/Team Science OBJECTIVES/SPECIFIC AIMS: The aims of this project are to: (1) examine placebo effects on subjective and objective outcome measures, (2) determine if an increase in the placebo is associated with changes in benefit, (3) evaluate if the trauma related insomnia placebo group in our study has different side effect reports compared with insomnia placebo participants in previous suvorexant trials, and (4) (Exploratory) examine associations between the placebo group’s characteristics (e.g., trauma/PTSD severity, demographics) and placebo effects. METHODS/STUDY POPULATION: The parent study is a randomized double-blind placebo-controlled clinical trial (clinicaltrials.gov ID: NCT02704754) of suvorexant for treatment of adults (age 18–55) with insomnia that started or worsened after trauma exposure. Suvorexant is a first in class orexin antagonist and is approved by the FDA for the indication of insomnia. In this 6-week trial, all participants initially take 10 mg of suvorexant/placebo, and the dose will be increased to 20 mg if participants continue to experience clinically significant insomnia symptoms 1 week after starting the medication. Sleep outcomes will be measured by polysomnography, daily sleep diary, and the Insomnia Severity Index. RESULTS/ANTICIPATED RESULTS: We hypothesize that (1) within the placebo group data both subjectively and objectively measured outcomes will similarly show improvement in insomnia symptoms, (2) the increase of the placebo medication dose will result in an increased benefit, (3) the trauma-related insomnia placebo group will have the same type and similar rate of side effects reported in previous suvorexant trials. DISCUSSION/SIGNIFICANCE OF IMPACT: Most previous studies examining placebo effects focused on pain and depression. Information obtained from this project will complement our current understanding of placebo effects by characterizing placebo effects on trauma-related insomnia. This study will inform the development of novel strategies to maximize utility of placebos in future clinical trials. Cambridge University Press 2018-11-21 /pmc/articles/PMC6799138/ http://dx.doi.org/10.1017/cts.2018.167 Text en © The Association for Clinical and Translational Science 2018 http://creativecommons.org/licenses/by/4.0/ This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Basic/Translational Science/Team Science Uweh, Kimberly 2420 Examining characteristics of placebo effects on trauma-related insomnia in a suvorexant trial |
title | 2420 Examining characteristics of placebo effects on trauma-related insomnia in a suvorexant trial |
title_full | 2420 Examining characteristics of placebo effects on trauma-related insomnia in a suvorexant trial |
title_fullStr | 2420 Examining characteristics of placebo effects on trauma-related insomnia in a suvorexant trial |
title_full_unstemmed | 2420 Examining characteristics of placebo effects on trauma-related insomnia in a suvorexant trial |
title_short | 2420 Examining characteristics of placebo effects on trauma-related insomnia in a suvorexant trial |
title_sort | 2420 examining characteristics of placebo effects on trauma-related insomnia in a suvorexant trial |
topic | Basic/Translational Science/Team Science |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6799138/ http://dx.doi.org/10.1017/cts.2018.167 |
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