PMID- 36399936 OWN - NLM STAT- MEDLINE DCOM- 20221220 LR - 20221221 IS - 1879-0046 (Electronic) IS - 0376-8716 (Linking) VI - 241 DP - 2022 Dec 1 TI - Lisdexamfetamine for the treatment of acute methamphetamine withdrawal: A pilot feasibility and safety trial. PG - 109692 LID - S0376-8716(22)00429-X [pii] LID - 10.1016/j.drugalcdep.2022.109692 [doi] AB - BACKGROUND: There is no effective treatment for methamphetamine withdrawal. This study aimed to determine the feasibility and safety of a tapering dose of lisdexamfetamine for the treatment of acute methamphetamine (MA) withdrawal. METHODS: Open-label, single-arm pilot study, in an inpatient drug and alcohol withdrawal unit assessing a tapering dose of oral lisdexamfetamine dimesylate commencing at 250 mg once daily, reducing by 50 mg per day to 50 mg on Day 5. Measures were assessed daily (days 0-7) with 21-day telephone follow-up. Feasibility was measured by the time taken to enrol the sample. Safety was the number of adverse events (AEs) by system organ class. Retention was the proportion to complete treatment. Other measures included the Treatment Satisfaction Questionnaire for Medication (TSQM), the Amphetamine Withdrawal Questionnaire and craving (Visual Analogue Scale). RESULTS: Ten adults seeking inpatient treatment for MA withdrawal (9 male, median age 37.1 years [IQR 31.7-41.9]), diagnosed with MA use disorder were recruited. The trial was open for 126 days; enroling one participant every 12.6 days. Eight of ten participants completed treatment (Day 5). Two participants left treatment early. There were no treatment-related serious adverse events (SAEs). Forty-seven AEs were recorded, 17 (36%) of which were potentially causally related, all graded as mild severity. Acceptability of the study drug by TSQM was rated at 100% at treatment completion. Withdrawal severity and craving reduced through the admission. CONCLUSION: A tapering dose regimen of lisdexamfetamine was safe and feasible for the treatment of acute methamphetamine withdrawal in an inpatient setting. CI - Copyright (c) 2022 The Authors. Published by Elsevier B.V. All rights reserved. FAU - Acheson, Liam S AU - Acheson LS AD - The National Drug and Alcohol Research Centre (NDARC), the University of New South Wales, Sydney, Australia; Alcohol and Drug Service, St Vincent's Hospital Sydney, Sydney, Australia; The National Centre for Clinical Research on Emerging Drugs (NCCRED), c/o the University of New South Wales, Sydney, Australia. Electronic address: liam.acheson@svha.org.au. FAU - Ezard, Nadine AU - Ezard N AD - The National Drug and Alcohol Research Centre (NDARC), the University of New South Wales, Sydney, Australia; Alcohol and Drug Service, St Vincent's Hospital Sydney, Sydney, Australia; The National Centre for Clinical Research on Emerging Drugs (NCCRED), c/o the University of New South Wales, Sydney, Australia; New South Wales Drug and Alcohol Clinical Research and Improvement Network (DACRIN), NSW, Australia. FAU - Lintzeris, Nicholas AU - Lintzeris N AD - New South Wales Drug and Alcohol Clinical Research and Improvement Network (DACRIN), NSW, Australia; The Langton Centre, South East Sydney Local Health District, Sydney, Australia; Discipline of Addiction Medicine, the University of Sydney, Sydney, Australia. FAU - Dunlop, Adrian AU - Dunlop A AD - New South Wales Drug and Alcohol Clinical Research and Improvement Network (DACRIN), NSW, Australia; Drug and Alcohol Clinical Services, Hunter New England Local Health District, Newcastle, Australia; School of Medicine and Public Health, the University of Newcastle, Newcastle, Australia. FAU - Brett, Jonathan AU - Brett J AD - Clinical Pharmacology and Toxicology, St Vincent's Hospital Sydney, Sydney, Australia; St. Vincent's Clinical School, the University of New South Wales, Sydney, Australia. FAU - Rodgers, Craig AU - Rodgers C AD - Alcohol and Drug Service, St Vincent's Hospital Sydney, Sydney, Australia. FAU - Gill, Anthony AU - Gill A AD - Alcohol and Drug Service, St Vincent's Hospital Sydney, Sydney, Australia. FAU - Christmass, Michael AU - Christmass M AD - Next Step Drug and Alcohol Services, Perth, Australia; National Drug Research Institute, Curtin University, Perth, Australia. FAU - McKetin, Rebecca AU - McKetin R AD - The National Drug and Alcohol Research Centre (NDARC), the University of New South Wales, Sydney, Australia. FAU - Farrell, Michael AU - Farrell M AD - The National Drug and Alcohol Research Centre (NDARC), the University of New South Wales, Sydney, Australia. FAU - Shoptaw, Steve AU - Shoptaw S AD - Department of Family Medicine, The University of California Los Angeles, Los Angeles, USA. FAU - Siefried, Krista J AU - Siefried KJ AD - The National Drug and Alcohol Research Centre (NDARC), the University of New South Wales, Sydney, Australia; Alcohol and Drug Service, St Vincent's Hospital Sydney, Sydney, Australia; The National Centre for Clinical Research on Emerging Drugs (NCCRED), c/o the University of New South Wales, Sydney, Australia. LA - eng PT - Clinical Trial PT - Journal Article DEP - 20221107 PL - Ireland TA - Drug Alcohol Depend JT - Drug and alcohol dependence JID - 7513587 RN - 0 (Central Nervous System Stimulants) RN - SJT761GEGS (Lisdexamfetamine Dimesylate) RN - 44RAL3456C (Methamphetamine) SB - IM MH - Adult MH - Humans MH - Male MH - *Alcoholism/drug therapy MH - *Amphetamine-Related Disorders/drug therapy MH - *Central Nervous System Stimulants/adverse effects MH - Lisdexamfetamine Dimesylate/adverse effects MH - *Methamphetamine/adverse effects MH - Pilot Projects MH - *Substance Withdrawal Syndrome/drug therapy MH - Treatment Outcome OTO - NOTNLM OT - Clinical trial OT - Lisdexamfetamine OT - Methamphetamine OT - Pharmacotherapy OT - Safety OT - Stimulant OT - Treatment OT - Withdrawal COIS- Conflict of interest LSA is supported by an NDARC PhD Scholarship. MF has received unrestricted funding for research purposes from Indivior and Sequiiris. SS has received clinical research supplies from Alkermes. NE and KJS are employed by NCCRED. No other investigators have any conflicts of interest to declare. EDAT- 2022/11/19 06:00 MHDA- 2022/12/15 06:00 CRDT- 2022/11/18 18:24 PHST- 2022/09/08 00:00 [received] PHST- 2022/10/28 00:00 [revised] PHST- 2022/10/28 00:00 [accepted] PHST- 2022/11/19 06:00 [pubmed] PHST- 2022/12/15 06:00 [medline] PHST- 2022/11/18 18:24 [entrez] AID - S0376-8716(22)00429-X [pii] AID - 10.1016/j.drugalcdep.2022.109692 [doi] PST - ppublish SO - Drug Alcohol Depend. 2022 Dec 1;241:109692. doi: 10.1016/j.drugalcdep.2022.109692. Epub 2022 Nov 7.