None listed
Conditions
Brief 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.
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 admissi
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
Sponsors
St Vincent's Hospital Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged 18 years and older • Presenting to drug treatment service seeking methamphetamine withdrawal treatment • Determined by an Addiction Medicine Specialist or Psychiatrist to have moderate to severe methamphetamine use disorder (DSM-5-TR criteria) • Reporting last use of methamphetamine within 72 hours of first dose of study drug • Point-of-care urine drug test positive for methamphetamine • Willing to provide written, informed consent
Exclusion criteria
• Concurrent moderate to severe use disorder of alcohol, opioids and/or sedative, hypnotics or anxiolytics (benzodiazepines or gamma-hydroxybutyrate (GHB)) (based on DSM-5TR criteria) • Lactating, pregnant or of childbearing potential and not willing to avoid becoming pregnant during the study • Acute severe mental/physical comorbidity that would interfere with study participation, as assessed by the site Principal Investigator (PI) • Currently experiencing psychosis (defined by a score of 4 of greater on at least two items of the psychosis (suspiciousness, hallucinations, and unusual thought content) items of the Brief Psychiatric Rating Scale (BPRS)) or current active suicidality (defined by a high risk on the Columbia Suicide Severity Rating Scale (C-SSRS) Screener) • Exposure to lisdexamfetamine, dexamphetamine, modafinil or methylphenidate in the four weeks prior to screening • Contraindications to lisdexamfetamine other than drug dependence (per product label) • Currently enrolled in another study that would interfere with study participation, as assessed by the site PI
Outcome results
None listed