Trial protocol of an open label pilot study of lisdexamfetamine for the treatment of acute methamphetamine withdrawal.

Alcoholism / drug therapy Amphetamine-Related Disorders / drug therapy Attention Deficit Disorder with Hyperactivity / drug therapy Central Nervous System Stimulants / adverse effects Double-Blind Method Humans Lisdexamfetamine Dimesylate / adverse effects Methamphetamine / adverse effects Pilot Projects Substance Withdrawal Syndrome / drug therapy Treatment Outcome

Journal

PloS one
ISSN: 1932-6203
Titre abrégé: PLoS One
Pays: United States
ID NLM: 101285081

Informations de publication

Date de publication:
2022
Historique:
received: 14 01 2022
accepted: 13 09 2022
entrez: 3 10 2022
pubmed: 4 10 2022
medline: 6 10 2022
Statut: epublish

Résumé

Methamphetamine (MA) use disorder is an important public health concern. MA withdrawal is often the first step in ceasing or reducing use. There are no evidence-based withdrawal treatments, and no medication is approved for the treatment of MA withdrawal. Lisdexamfetamine (LDX) dimesilate, used in the treatment of attention deficit hyperactivity disorder and binge eating disorder has the potential as an agonist therapy to ameliorate withdrawal symptoms, and improve outcomes for patients. A single arm, open-label pilot study to test the safety and feasibility of LDX for the treatment of MA withdrawal. Participants will be inpatients in a drug and alcohol withdrawal unit, and will receive a tapering dose of LDX over five days: 250mg LDX on Day 1, reducing by 50mg per day to 50mg on Day 5. Optional inpatient Days 6 and 7 will allow for participants to transition to ongoing treatment. Participants will be followed-up on Days 14, 21 and 28. All participants will also receive standard inpatient withdrawal care. The primary outcomes are safety (measured by adverse events, changes in vital signs, changes in suicidality and psychosis) and feasibility (the time taken to enrol the sample, proportion of screen / pre-screen failures). Secondary outcomes are acceptability (treatment satisfaction questionnaire, medication adherence, concomitant medications, qualitative interviews), retention to protocol (proportion retained to primary and secondary endpoints), changes in withdrawal symptoms (Amphetamine Withdrawal Questionnaire) and craving for MA (visual analogue scale), and sleep outcomes (continuous actigraphy and daily sleep diary). This is the first study to assess lisdexamfetamine for the treatment of acute MA withdrawal. If safe and feasible results will go to informing the development of multi-centre randomised controlled trials to determine the efficacy of the intervention.

Identifiants

DOI: 10.1371/journal.pone.0275371 PMID: 36190973 PMC: PMC9529099
pubmed: 36190973
doi: 10.1371/journal.pone.0275371
pii: PONE-D-22-01262
pmc: PMC9529099
doi:

Substances chimiques

Central Nervous System Stimulants 0
Methamphetamine 44RAL3456C
Lisdexamfetamine Dimesylate SJT761GEGS

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e0275371

Déclaration de conflit d'intérêts

I have read the journal’s policy and the authors of this manuscript have the following competing interests: Michael Farrell as Director of NDARC has received unrestricted funding for research purposes from Indivior and Sequiiris. Steve Shoptaw has received clinical research supplies from Alkermes. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

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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.
ORCID: 0000-0002-2343-5504

Nadine Ezard (N)

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), Sydney, Australia.

Nicholas Lintzeris (N)

New South Wales Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Sydney, 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), Sydney, 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.
ORCID: 0000-0001-9782-1849

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, California, United States of America.
ORCID: 0000-0002-3583-0026

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 › Troubles mentaux › Troubles liés à une substance › Troubles liés à l'alcool › Alcoolisme › Trial protocol of an open label pilot study of...
questionsmedicales.fr › Troubles mentaux › Troubles liés à une substance › Troubles liés aux amphétamines › Trial protocol of an open label pilot study of...
questionsmedicales.fr › Troubles mentaux › Troubles du développement neurologique › Troubles déficitaires de l'attention et du comportement perturbateur › Trouble déficitaire de l'attention avec hyperactivité › Trial protocol of an open label pilot study of...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Agents du système nerveux central › Stimulants du système nerveux central › Trial protocol of an open label pilot study of...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méthode en double aveugle › Trial protocol of an open label pilot study of...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Trial protocol of an open label pilot study of...
questionsmedicales.fr › Composés chimiques organiques › Amines › Éthylamines › Phénéthylamines › Amphétamines › Amfétamine › Dexamfétamine › Dimésylate de lisdexamfétamine › Trial protocol of an open label pilot study of...
questionsmedicales.fr › Composés chimiques organiques › Amines › Éthylamines › Phénéthylamines › Amphétamines › Métamfétamine › Trial protocol of an open label pilot study of...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Projets pilotes › Trial protocol of an open label pilot study of...
questionsmedicales.fr › Troubles mentaux › Troubles liés à une substance › Syndrome de sevrage › Trial protocol of an open label pilot study of...
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 › Trial protocol of an open label pilot study of...