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Baseline severity a...
Baseline severity and the prediction of placebo response in clinical trials for alcohol dependence: A meta-regression analysis to develop an enrichment strategy
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Scherrer, B. (author)
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Guiraud, J. (author)
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Addolorato, G. (author)
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Aubin, H. J. (author)
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- De Bejczy, Andrea, 1975 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
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Benyamina, A. (author)
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van den Brink, W. (author)
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Caputo, F. (author)
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Dematteis, M. (author)
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Goudriaan, A. E. (author)
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Gual, A. (author)
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Kiefer, F. (author)
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Leggio, L. (author)
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Lesch, O. M. (author)
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Maremmani, I. (author)
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Nutt, D. J. (author)
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Paille, F. (author)
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Perney, P. (author)
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Poulnais, R. (author)
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Raffaillac, Q. (author)
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Rehm, J. (author)
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Rolland, B. (author)
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Simon, N. (author)
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- Söderpalm, Bo, 1959 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för psykiatri och neurokemi,Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
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Sommer, W. H. (author)
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Walter, H. (author)
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Spanagel, R. (author)
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(creator_code:org_t)
- 2021-08-21
- 2021
- English.
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In: Alcoholism-Clinical and Experimental Research. - : Wiley. - 0145-6008 .- 1530-0277. ; 45:9, s. 1722-1734
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
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- Background There is considerable unexplained variability in alcohol abstinence rates (AR) in the placebo groups of randomized controlled trials (RCTs) for alcohol dependence (AD). This is of particular interest because placebo responses correlate negatively with treatment effect size. Recent evidence suggests that the placebo response is lower in very heavy drinkers who show no "spontaneous improvement" prior to treatment initiation (high-severity population) than in a mild-severity population and in studies with longer treatment duration. We systematically investigated the relationship between population severity, treatment duration, and the placebo response in AR to inform a strategy aimed at reducing the placebo response and thereby increasing assay sensitivity in RCTs for AD. Methods We conducted a systematic literature review on placebo-controlled RCTs for AD.We assigned retained RCTs to high- or mild-severity groups of studies based on baseline drinking risk levels and abstinence duration before treatment initiation. We tested the effects of population severity and treatment duration on the placebo response in AR using meta-regression analysis. Results Among the 19 retained RCTs (comprising 1996 placebo-treated patients), 11 trials were high-severity and 8 were mild-severity RCTs. The between-study variability in AR was lower in the high-severity than in the mild-severity studies (interquartile range: 7.4% vs. 20.9%). The AR in placebo groups was dependent on population severity (p = 0.004) and treatment duration (p = 0.017) and was lower in the high-severity studies (16.8% at 3 months) than the mild-severity studies (36.7% at 3 months). Conclusions Pharmacological RCTs for AD should select high-severity patients to decrease the magnitude and variability in the placebo effect and and improve the efficiency of drug development efforts for AD.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Hälsovetenskap -- Beroendelära (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Health Sciences -- Substance Abuse (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Neurovetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Neurosciences (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Psykiatri (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Psychiatry (hsv//eng)
Keyword
- alcohol dependence
- alcohol use disorder
- placebo response
- predictor
- randomized controlled trials
- double-blind
- risk level
- naltrexone
- drinking
- efficacy
- acamprosate
- nalmefene
- safety
- trajectories
- consumption
- Substance Abuse
Publication and Content Type
- ref (subject category)
- art (subject category)
Find in a library
To the university's database
- By the author/editor
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Scherrer, B.
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Guiraud, J.
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Addolorato, G.
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Aubin, H. J.
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De Bejczy, Andre ...
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Benyamina, A.
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show more...
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van den Brink, W ...
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Caputo, F.
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Dematteis, M.
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Goudriaan, A. E.
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Gual, A.
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Kiefer, F.
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Leggio, L.
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Lesch, O. M.
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Maremmani, I.
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Nutt, D. J.
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Paille, F.
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Perney, P.
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Poulnais, R.
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Raffaillac, Q.
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Rehm, J.
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Rolland, B.
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Simon, N.
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Söderpalm, Bo, 1 ...
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Sommer, W. H.
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Walter, H.
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Spanagel, R.
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Health Sciences
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and Substance Abuse
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Neurosciences
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Psychiatry
- Articles in the publication
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Alcoholism-Clini ...
- By the university
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University of Gothenburg