An open-label trial of oral lisdexamfetamine for the treatment of acute methamphetamine withdrawal

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000045819

Acronym

OLAM

Enrollment

Registered

2021-01-18

Start date

2021-04-23

Completion date

2021-11-12

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial is an open-label, single-arm safety and feasibility trial of lisdexamfetamine for the management of acute methamphetamine withdrawal. Participants presenting for inpatient management of methamphetamine withdrawal will receive a tapering dose of lsidexamfetamine, starting at 250mg on day 1, reducing by 50mg per day to 50mg on day 5. Participants will be encouraged to remain in treatment for another two days for ongoing monitoring and will be followed up weekly for three weeks post discharge. We hypothesise that lisdexamfetamine is safe and feasible for the management of acute methamphetamine withdrawal.

Interventions

Lisdexamfetamine (Vyvanse) Dose: Tapering dose of 250mg once daily on Day 1 reducing by 50mg per day until 50mg on Day 5 Duration: 5 days Mode: Oral tablet Adherence: Dosing will be supervised by qualified nursing staff and entered into the participant medication chart. Any refused or un-taken doses will be noted in the participant medication chart

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• Adults over the age of 18 years • Presenting to inpatient drug treatment services seeking treatment for acute MA withdrawal • Methamphetamine use disorder as determined by an addiction medicine specialist according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Criteria • Last MA use within 72 hours of planned first study drug dose • Have a positive urine drug screen for methamphetamines • Willing and able to provide written informed consent and willingness to participate in and comply with the study

Exclusion criteria

• Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study • Expected concurrent withdrawal from alcohol, opioids, benzodiazepines, gamma-hydroxybutyrate or other gabapentinoids • Known contradictions to lisdexamfetamine • Medically significant condition which in the opinion of a study medical officer renders a patient unsuitable for the study • Involuntary patients (e.g. under the Mental Health Act in NSW

Outcome results