Oral Lisdexamfetamine for the treatment of Acute Methamphetamine withdrawal (the OLAM trial): A randomised controlled trial
- Conditions
- Acute methamphetamine withdrawalMental Health - Addiction
- Registration Number
- ACTRN12624001061527
- Lead Sponsor
- St Vincent's Hospital Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 184
•Aged 18 years and older
•Presenting to drug treatment service seeking methamphetamine withdrawal treatment
•Determined by an Addiction Medicine Specialist or Psychiatrist to have 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 and able to provide written, informed consent
•Concurrent dependence on non-prescribed opioids or benzodiazepines, or alcohol 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
•Contraindications to lisdexamfetamine (per product label) other than drug dependence:
•Acute severe mental/physical comorbidity that would interfere with study participation, as assessed by the site PI
•Currently experiencing psychosis or suicidality
•Exposure to lisdexamfetamine, dexamphetamine, modafinil or methylphenidate in the 4 weeks prior to screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method