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Treating alcohol de...
Treating alcohol dependence with an abuse and misuse deterrent formulation of sodium oxybate: Results of a randomised, double-blind, placebo-controlled study
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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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Batel, P. (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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Caputo, F. (author)
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Goudriaan, A. E. (author)
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Gual, A. (author)
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Lesch, O. (author)
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Maremmani, I. (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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- 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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Spanagel, R. (author)
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Walter, H. (author)
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van den Brink, W. (author)
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(creator_code:org_t)
- Elsevier BV, 2021
- 2021
- English.
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In: European Neuropsychopharmacology. - : Elsevier BV. - 0924-977X. ; 52, s. 18-30
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Abstract
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- Sodium oxybate (SMO) has been approved in Italy and Austria for the maintenance of abstinence in alcohol dependent (AD) patients. Although SMO is well tolerated in AD patients, cases of abuse and misuse have been reported outside the therapeutic setting. Here we report on a phase IIb double-blind, randomized, placebo-controlled trial for the maintenance of abstinence in AD patients with a new abuse and misuse deterrent formulation of SMO. A total of 509 AD patients were randomized to 12 weeks of placebo or one of four SMO doses (0.75, 1.25, 1.75 or 2.25 g t.i.d.) followed by a one-week medication-free period. The primary endpoint was the percentage of days abstinent (PDA) at end of treatment. An unexpectedly high placebo response (mean 73%, median 92%) was observed. This probably compromised the demonstration of efficacy in the PDA, but several secondary endpoints showed statistically significant improvements. A post-hoc subgroup analysis based on baseline severity showed no improvements in the mild group, but statistically significant improvements in the severe group: PDA: mean difference +15%, Cohen's d = 0.42; abstinence: risk difference +18%, risk ratio = 2.22. No safety concerns were reported. Although the primary endpoint was not significant in the overall population, several secondary endpoints were significant in the intent-to-treat population and post-hoc results showed that treatment with SMO was associated with a significant improvement in severe AD patients which is consistent with previous findings. New trials are warranted that take baseline severity into consideration. (C) 2021 The Authors. Published by Elsevier B.V.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Psykiatri (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Psychiatry (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Neurovetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Neurosciences (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)
Keyword
- Alcohol dependence
- Alcohol use disorders
- Maintenance of abstinence
- Sodium oxybate
- GHB
- RCT
- gamma-hydroxybutyric acid
- base-line trajectories
- withdrawal syndrome
- risk level
- naltrexone
- drinking
- efficacy
- acamprosate
- nalmefene
- therapy
- Neurosciences & Neurology
- Pharmacology & Pharmacy
- Psychiatry
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Guiraud, J.
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Addolorato, G.
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Aubin, H. J.
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Batel, P.
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De Bejczy, Andre ...
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Caputo, F.
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show more...
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Goudriaan, A. E.
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Gual, A.
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Lesch, O.
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Maremmani, I.
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Perney, P.
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Poulnais, R.
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Raffaillac, Q.
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Söderpalm, Bo, 1 ...
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Spanagel, R.
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Walter, H.
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van den Brink, W ...
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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 Clinical Medicin ...
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and Psychiatry
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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 Basic Medicine
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and Pharmacology and ...
- Articles in the publication
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European Neurops ...
- By the university
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University of Gothenburg