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
St Vincent's Hospital Sydney
184 participants
Jul 21, 2025
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
Plain Language Summary
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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 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)
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ACTRN12624001061527