Katrine Melby1, Rolf W Gråwe2, Trond O Aamo3, Øyvind Salvesen4, Olav Spigset5. 1. Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology - NTNU, Trondheim, Norway; Blue Cross Lade Addiction Treatment Center, Trondheim, Norway; Department of Clinical Pharmacology, St. Olav University Hospital, Trondheim, Norway. Electronic address: Katrine.melby@stolav.no. 2. Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology - NTNU, Trondheim, Norway; Department of Research and Development, Division of Psychiatry, St. Olav University Hospital, Trondheim, Norway. 3. Blue Cross Lade Addiction Treatment Center, Trondheim, Norway; Department of Clinical Pharmacology, St. Olav University Hospital, Trondheim, Norway. 4. Department of Public Health and General Practice, Norwegian University of Science and Technology, Trondheim, Norway. 5. Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology - NTNU, Trondheim, Norway; Department of Clinical Pharmacology, St. Olav University Hospital, Trondheim, Norway.
Abstract
BACKGROUND: In a pilot study, intranasal oxytocin was demonstrated to reduce the benzodiazepine dose needed to relieve withdrawal symptoms during alcohol detoxification. The aim of the present study was to compare the effect of oxytocin and placebo during a three-day period of alcohol detoxification at an addiction treatment center in Norway. METHODS: Randomized, double-blind, placebo-controlled trial with 40 patients fulfilling criteria for ICD-10 diagnosis of alcohol dependence (F10.2), admitted for alcohol detoxification and withdrawal treatment. The benzodiazepine oxazepam was given as symptom-triggered treatment based on the scores of the Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) scale. Participants were randomized to receive either intranasal oxytocin (24 IU twice daily) or placebo. PRIMARY OUTCOME: Oxazepam dose required to complete a three-day course of detoxification. SECONDARY OUTCOMES: Scores of the CIWA-Ar, the 10-item Hopkins Symptom Check List (HSCL-10), and self-reported total number of hours of sleep. RESULTS: The mean total oxazepam dose (± standard deviation) was 56.8 ± 72.8 mg in the oxytocin group and 79.0 ± 122.9 in the placebo group (p = 0.490; difference -22.3 mg; 95% confidence interval (CI) -86.9 to +42.4 mg). The findings were inconclusive as to whether a difference in the CIWA-Ar score (5.94 ± 3.86 vs. 6.48 ± 3.92; p = 0.665) or in any of the other secondary outcomes was present. No serious adverse events were reported. CONCLUSION: Compared to placebo, intranasal oxytocin did not significantly reduce the oxazepam dose needed to complete a 3-day course of alcohol detoxification and withdrawal treatment.
RCT Entities:
BACKGROUND: In a pilot study, intranasal oxytocin was demonstrated to reduce the benzodiazepine dose needed to relieve withdrawal symptoms during alcohol detoxification. The aim of the present study was to compare the effect of oxytocin and placebo during a three-day period of alcohol detoxification at an addiction treatment center in Norway. METHODS: Randomized, double-blind, placebo-controlled trial with 40 patients fulfilling criteria for ICD-10 diagnosis of alcohol dependence (F10.2), admitted for alcohol detoxification and withdrawal treatment. The benzodiazepineoxazepam was given as symptom-triggered treatment based on the scores of the Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) scale. Participants were randomized to receive either intranasal oxytocin (24 IU twice daily) or placebo. PRIMARY OUTCOME: Oxazepam dose required to complete a three-day course of detoxification. SECONDARY OUTCOMES: Scores of the CIWA-Ar, the 10-item Hopkins Symptom Check List (HSCL-10), and self-reported total number of hours of sleep. RESULTS: The mean total oxazepam dose (± standard deviation) was 56.8 ± 72.8 mg in the oxytocin group and 79.0 ± 122.9 in the placebo group (p = 0.490; difference -22.3 mg; 95% confidence interval (CI) -86.9 to +42.4 mg). The findings were inconclusive as to whether a difference in the CIWA-Ar score (5.94 ± 3.86 vs. 6.48 ± 3.92; p = 0.665) or in any of the other secondary outcomes was present. No serious adverse events were reported. CONCLUSION: Compared to placebo, intranasal oxytocin did not significantly reduce the oxazepam dose needed to complete a 3-day course of alcohol detoxification and withdrawal treatment.
Authors: Joanna Peris; Katye Totten; Darrice Montgomery; Hannah Lester; Arnika Weatherington; Brian Piotrowski; Sam Sowell; Kristen Doyle; Karen Scott; Yalun Tan; Kaley A MacFadyen; Hannah Engle; Annette D de Kloet; Eric G Krause Journal: Alcohol Clin Exp Res Date: 2022-01-07 Impact factor: 3.455
Authors: Julianne C Flanagan; Paul J Nietert; Lauren Sippel; Amber M Jarnecke; Charli Kirby; Jasara N Hogan; Andrea A Massa; Jessica Brower; Sudie E Back; Dominic Parrott Journal: J Psychiatr Res Date: 2022-06-09 Impact factor: 5.250
Authors: Katrine Melby; Ole B Fasmer; Tone E Henriksen; Rolf W Gråwe; Trond O Aamo; Olav Spigset Journal: PLoS One Date: 2020-02-13 Impact factor: 3.240