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

Adult Humans Male Alcoholism / drug therapy Amphetamine-Related Disorders / drug therapy Central Nervous System Stimulants / adverse effects Lisdexamfetamine Dimesylate / adverse effects Methamphetamine / adverse effects Pilot Projects Substance Withdrawal Syndrome / drug therapy Treatment Outcome
Clinical trial Lisdexamfetamine Methamphetamine Pharmacotherapy Safety Stimulant Treatment Withdrawal

Journal

Drug and alcohol dependence
ISSN: 1879-0046
Titre abrégé: Drug Alcohol Depend
Pays: Ireland
ID NLM: 7513587

Informations de publication

Date de publication:
01 Dec 2022
Historique:
received: 08 09 2022
revised: 28 10 2022
accepted: 28 10 2022
pubmed: 19 11 2022
medline: 15 12 2022
entrez: 18 11 2022
Statut: ppublish

Résumé

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. 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). 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. A tapering dose regimen of lisdexamfetamine was safe and feasible for the treatment of acute methamphetamine withdrawal in an inpatient setting.

Sections du résumé

BACKGROUND 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 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 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 CONCLUSIONS
A tapering dose regimen of lisdexamfetamine was safe and feasible for the treatment of acute methamphetamine withdrawal in an inpatient setting.

Identifiants

DOI: 10.1016/j.drugalcdep.2022.109692 PMID: 36399936
pubmed: 36399936
pii: S0376-8716(22)00429-X
doi: 10.1016/j.drugalcdep.2022.109692
pii:
doi:

Substances chimiques

Central Nervous System Stimulants 0
Lisdexamfetamine Dimesylate SJT761GEGS
Methamphetamine 44RAL3456C

Types de publication

Clinical Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

109692

Informations de copyright

Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

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.

Auteurs

Liam S Acheson (LS)

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.

Nadine Ezard (N)

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.

Nicholas Lintzeris (N)

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.

Adrian Dunlop (A)

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.

Jonathan Brett (J)

Clinical Pharmacology and Toxicology, St Vincent's Hospital Sydney, Sydney, Australia; St. Vincent's Clinical School, the University of New South Wales, Sydney, Australia.

Craig Rodgers (C)

Alcohol and Drug Service, St Vincent's Hospital Sydney, Sydney, Australia.

Anthony Gill (A)

Alcohol and Drug Service, St Vincent's Hospital Sydney, Sydney, Australia.

Michael Christmass (M)

Next Step Drug and Alcohol Services, Perth, Australia; National Drug Research Institute, Curtin University, Perth, Australia.

Rebecca McKetin (R)

The National Drug and Alcohol Research Centre (NDARC), the University of New South Wales, Sydney, Australia.

Michael Farrell (M)

The National Drug and Alcohol Research Centre (NDARC), the University of New South Wales, Sydney, Australia.

Steve Shoptaw (S)

Department of Family Medicine, The University of California Los Angeles, Los Angeles, USA.

Krista J Siefried (KJ)

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.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Lisdexamfetamine for the treatment of acute...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Lisdexamfetamine for the treatment of acute...
questionsmedicales.fr › Troubles mentaux › Troubles liés à une substance › Troubles liés à l'alcool › Alcoolisme › Lisdexamfetamine for the treatment of acute...
questionsmedicales.fr › Troubles mentaux › Troubles liés à une substance › Troubles liés aux amphétamines › Lisdexamfetamine for the treatment of acute...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Agents du système nerveux central › Stimulants du système nerveux central › Lisdexamfetamine for the treatment of acute...
questionsmedicales.fr › Composés chimiques organiques › Amines › Éthylamines › Phénéthylamines › Amphétamines › Amfétamine › Dexamfétamine › Dimésylate de lisdexamfétamine › Lisdexamfetamine for the treatment of acute...
questionsmedicales.fr › Composés chimiques organiques › Amines › Éthylamines › Phénéthylamines › Amphétamines › Métamfétamine › Lisdexamfetamine for the treatment of acute...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Projets pilotes › Lisdexamfetamine for the treatment of acute...
questionsmedicales.fr › Troubles mentaux › Troubles liés à une substance › Syndrome de sevrage › Lisdexamfetamine for the treatment of acute...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › Lisdexamfetamine for the treatment of acute...