RecruitingPhase 4ACTRN12624001061527

Oral Lisdexamfetamine for the treatment of Acute Methamphetamine withdrawal (the OLAM trial): A randomised controlled trial

Efficacy of Oral Lisdexamfetamine for the treatment of Acute Methamphetamine withdrawal symptoms (the OLAM trial): A randomised controlled trial


Sponsor

St Vincent's Hospital Sydney

Enrollment

184 participants

Start Date

Jul 21, 2025

Study Type

Interventional

Conditions

Summary

Untreated methamphetamine withdrawal is a significant barrier to people meeting their treatment goals. Lisdexamfetamine has the potential to help manage withdrawal from methamphetamine. This study is a randomised controlled trial of a tapering dose of lisdexamfetamine for the treatment of acute methamphetamine withdrawal, over a 7 day period in hospital. We will then follow up participants for 84 days.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Methamphetamine withdrawal can be very distressing and is one of the main reasons people struggle to reduce or stop their use. Symptoms like severe fatigue, low mood, and intense cravings make it hard to get through the early stages of treatment. This study is testing whether a medication called lisdexamfetamine — a stimulant already approved for ADHD — can safely ease these withdrawal symptoms. Participants admitted to a hospital drug treatment service will be randomly assigned to receive either lisdexamfetamine or a placebo over seven days, on a tapering dose schedule. Everyone stays in hospital during the treatment phase and is then followed up for 84 days to see how they are doing. The goal is to reduce the discomfort of withdrawal and help more people successfully complete treatment. You may be eligible if you are 18 or older, have moderate to severe methamphetamine use disorder as assessed by a specialist, used methamphetamine within the last 72 hours, and have a positive urine test for methamphetamine. People who are pregnant, currently experiencing psychosis, or who have significant dependence on alcohol, opioids, or sedatives are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Lisdexamfetamine dimesylate 250mg, oral once daily, reducing over 7 days plus standard care withdrawal management. Participants will be blinded to the taper in this trial, Participants in the active g

Lisdexamfetamine dimesylate 250mg, oral once daily, reducing over 7 days plus standard care withdrawal management. Participants will be blinded to the taper in this trial, Participants in the active group will recieve 250mg lisdexamfetamine on Day 1, reducing my 50mg per day followed by a 2 day placebo washout. Participants will recieve 5 capsules per day of 50mg lisdexamfetamine (and from Day 2) placebo to make up the daily dose, all at once each morning This will occur during inpatient admission for acute methamphetamine withdrawal, and the medication will be administered by registered nurses Adherence will be monitored by nursing supervised dosing as per standard procedures for all schedule 8 medications, and recorded in the Schedule 8 log and the participant's individual medical records. Placebo capsules will be manufactured to be indistinguashable from active medication, and will be comprised of a gelatine capsule and microcrystaline cellulose filling. Placebo capsules will be administered along side active capsules to blind taper of the active medication All participants will recieve standard care psychosocial support during the 7-day inpatient period in line with each site's current clinical practice, comprising of psychosocial care (i.e. groups, psychoeducation etc offered daily) and/or case management. This will be monitored via self report and audit of medical records


Locations(5)

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW,WA,VIC, Australia

Concord Repatriation Hospital - Concord

NSW,WA,VIC, Australia

Belmont Hospital - Belmont

NSW,WA,VIC, Australia

Box Hill Hospital - Box Hill

NSW,WA,VIC, Australia

Next Step Community Alcohol and Drug Service East Perth - East Perth

NSW,WA,VIC, Australia

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ACTRN12624001061527