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| Journal of psychopharmacology (Oxford, England). 2022 Jul 7. doi: 10.1177/02698811221104063 |
| Sodium oxybate for the maintenance of abstinence in alcohol-dependent patients: An international, multicenter, randomized, double-blind, placebo-controlled trial. |
| Guiraud J1, Addolorato G2, Antonelli M3, Aubin HJ4, de Bejczy A5, Benyamina A6, Cacciaglia R7, Caputo F8, Dematteis M9, Ferrulli A10, Goudriaan AE11, Gual A12, Lesch OM13, Maremmani I14, Mirijello A15, Nutt DJ16, Paille F17, Perney P18, Poulnais R19, Raffaillac Q20, Rehm J21, Rolland B22, Rotondo C23, Scherrer B24, Simon N25, Skala K26, Söderpalm B27, Somaini L28, Sommer WH29, Spanagel R30, Vassallo GA31, Walter H32, van den Brink W33 |
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Abstract BACKGROUND: Sodium oxybate (SMO) has been shown to be effective in the maintenance of abstinence (MoA) in alcohol-dependent patients in a series of small randomized controlled trials (RCTs). These results needed to be confirmed by a large trial investigating the treatment effect and its sustainability after medication discontinuation. AIMS: To confirm the SMO effect on (sustained) MoA in detoxified alcohol-dependent patients. METHODS: Large double-blind, randomized, placebo-controlled trial in detoxified adult alcohol-dependent outpatients (80% men) from 11 sites in four European countries. Patients were randomized to 6 months SMO (3.3-3.9 g/day) or placebo followed by a 6-month medication-free period. Primary outcome was the cumulative abstinence duration (CAD) during the 6-month treatment period defined as the number of days with no alcohol use. Secondary outcomes included CAD during the 12-month study period. RESULTS: Of the 314 alcohol-dependent patients randomized, 154 received SMO and 160 received placebo. Based on the pre-specified fixed-effect two-way analysis of variance including the treatment-by-site interaction, SMO showed efficacy in CAD during the 6-month treatment period: mean difference +43.1 days, 95% confidence interval (17.6-68.5; = 0.001). Since significant heterogeneity of effect across sites and unequal sample sizes among sites ( = 3-66) were identified, a site-level random meta-analysis was performed with results supporting the pre-specified analysis: mean difference +32.4 days, = 0.014. The SMO effect was sustained during the medication-free follow-up period. SMO was well-tolerated. CONCLUSIONS: Results of this large RCT in alcohol-dependent patients demonstrated a significant and clinically relevant sustained effect of SMO on CAD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04648423. |
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KEYWORDS: Alcohol dependence, GHB, RCT, alcohol use disorders, maintenance of abstinence, sodium oxybate |
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Publikations ID: 35796481 Quelle: öffnen |
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