Lisdexamfetamine for the treatment of acute methamphetamine withdrawal: A pilot feasibility and safety trial

Affiliations

¹ 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.
² 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.
³ 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.
⁴ 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.
⁵ Clinical Pharmacology and Toxicology, St Vincent's Hospital Sydney, Sydney, Australia; St. Vincent's Clinical School, the University of New South Wales, Sydney, Australia.
⁶ Alcohol and Drug Service, St Vincent's Hospital Sydney, Sydney, Australia.
⁷ Next Step Drug and Alcohol Services, Perth, Australia; National Drug Research Institute, Curtin University, Perth, Australia.
⁸ The National Drug and Alcohol Research Centre (NDARC), the University of New South Wales, Sydney, Australia.
⁹ Department of Family Medicine, The University of California Los Angeles, Los Angeles, USA.
¹⁰ 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.

PMID: 36399936
DOI: 10.1016/j.drugalcdep.2022.109692

Clinical Trial

Lisdexamfetamine for the treatment of acute methamphetamine withdrawal: A pilot feasibility and safety trial

Liam S Acheson et al. Drug Alcohol Depend. 2022.

. 2022 Dec 1:241:109692.

doi: 10.1016/j.drugalcdep.2022.109692. Epub 2022 Nov 7.

Authors

Affiliations

¹ 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.
² 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.
³ 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.
⁴ 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.
⁵ Clinical Pharmacology and Toxicology, St Vincent's Hospital Sydney, Sydney, Australia; St. Vincent's Clinical School, the University of New South Wales, Sydney, Australia.
⁶ Alcohol and Drug Service, St Vincent's Hospital Sydney, Sydney, Australia.
⁷ Next Step Drug and Alcohol Services, Perth, Australia; National Drug Research Institute, Curtin University, Perth, Australia.
⁸ The National Drug and Alcohol Research Centre (NDARC), the University of New South Wales, Sydney, Australia.
⁹ Department of Family Medicine, The University of California Los Angeles, Los Angeles, USA.
¹⁰ 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.

PMID: 36399936
DOI: 10.1016/j.drugalcdep.2022.109692

Abstract

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.

Keywords: Clinical trial; Lisdexamfetamine; Methamphetamine; Pharmacotherapy; Safety; Stimulant; Treatment; Withdrawal.

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Conflict of interest statement

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.

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Lisdexamfetamine for the treatment of acute methamphetamine withdrawal: A pilot feasibility and safety trial

Affiliations

Lisdexamfetamine for the treatment of acute methamphetamine withdrawal: A pilot feasibility and safety trial

Authors

Affiliations

Abstract

Conflict of interest statement

Publication types

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Medical