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Trial registered on ANZCTR
Registration number
ACTRN12624001061527
Ethics application status
Approved
Date submitted
2/08/2024
Date registered
3/09/2024
Date last updated
3/09/2024
Date data sharing statement initially provided
3/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Oral Lisdexamfetamine for the treatment of Acute Methamphetamine withdrawal (the OLAM trial): A randomised controlled trial
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Scientific title
Efficacy of Oral Lisdexamfetamine for the treatment of Acute Methamphetamine withdrawal symptoms (the OLAM trial): A randomised controlled trial
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Secondary ID [1]
312630
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None
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Universal Trial Number (UTN)
U1111-1311-5066
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Trial acronym
OLAM
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Linked study record
This study is informed by the pilot trial of oral lisdexamfetamine for the treatment of acute methamphetamine withdrawal (ACTRN12621000045819)
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Health condition
Health condition(s) or problem(s) studied:
Acute methamphetamine withdrawal
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Condition category
Condition code
Mental Health
331180
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0
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Lisdexamfetamine dimesylate 250mg, oral once daily, reducing over 7 days plus standard of 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 occure 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 of 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
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Intervention code [1]
329149
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Treatment: Drugs
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Comparator / control treatment
Matched placebo; plus standard of care withdrawal maangement. Participants will recieve 5 capsules of matched placebo per day over 7 days administered all at once in the morning
Placebo capsules will be manufactured to be indistinguashable from active medication, and will be comprised of a gelatine capsule and microcrystaline cellulose filling.
All participants will recieve standard of 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
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Control group
Placebo
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Outcomes
Primary outcome [1]
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To determine the effectiveness of a tapering dose regimen of lisdexamfetamine to ameliorate the symptoms of acute methamphetamine withdrawal over 7 days
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Assessment method [1]
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Between-group mean difference in withdrawal severity over 7 days measured using the Amphetamine Withdrawal Questionnaire (AWQ)
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Timepoint [1]
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Days 0 (baseline), 1, 2, 3, 4, 5, 6, 7 (primary timepoint) post-baseline
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Secondary outcome [1]
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Retention in treatment
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Assessment method [1]
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Days retained in treatment assessed via medical record audit
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Timepoint [1]
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Upon conclusion of the study
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Secondary outcome [2]
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Treatment satisfaction
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Assessment method [2]
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Treatment Satisfaction Questionnaire for Medicines II (TSQM-II)
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Timepoint [2]
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Days 5 and 7 post baseline
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Secondary outcome [3]
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Sleep quality and duration
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Assessment method [3]
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Continuous actigraphy and modified Consensus Sleep Diary (CSD), assessed together as a composite outcome
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Timepoint [3]
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Days 1, 2, 3, 4, 5, 6, 7 post-baseline
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Secondary outcome [4]
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Anxiolytic / sedative medication utilisation for symptom management
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Assessment method [4]
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Total anxiolytic / sedative (diazepam daily dose equivalent) medication administration, assessed via audit of medical records
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Timepoint [4]
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Days 1, 2, 3, 4, 5, 6, 7 post baseline
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Secondary outcome [5]
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Safety
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Assessment method [5]
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Adverse event rate, assessed using NHMRC guidelines for assessing Adverse Events and the US Department of Health and Human Services (DHHS) National Institutes of Health (NIH) Division of AIDS (DAIDS) Table for grading the severity of adults and paediatric adverse events. Common adverse events include loss of appetite, dry mouth and insomnia
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Timepoint [5]
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Up to Day 28 post baseline
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Secondary outcome [6]
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Post-intervention withdrawal symptoms
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Assessment method [6]
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The Amphetamine Withdrawal Questionnaire (AWQ)
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Timepoint [6]
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Days 14, 21, 28 post baseline
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Secondary outcome [7]
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Methamphetamine use
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Assessment method [7]
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Timeline Followback (TLFB)
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Timepoint [7]
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Days 14, 21, 28, 56, 84 post baseline
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Secondary outcome [8]
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Depression and anxiety
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Assessment method [8]
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Depression And Anxiety Severity Scale 21 (DASS-21)
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Timepoint [8]
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Days 7, 14, 21, 28, 56, 84 post baseline
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Secondary outcome [9]
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Post-withdrawal care
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Assessment method [9]
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Self report engagement in ongoing methamphetamine use disorder treatment
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Timepoint [9]
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Days 14, 21, 28, 56, 84 post baseline
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Secondary outcome [10]
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Cost Effectiveness: Quality adjusted life years (QALYs) and incremental cost effectiveness ratio (ICER)
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Assessment method [10]
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Resource use including all clinical services provided as trial interventions and management of serious adverse events, PROMIS-29 and self-reported engagement in treatment
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Timepoint [10]
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Up to Day 28 post baseline
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Secondary outcome [11]
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Anti-psychotic medication utilisation for symptom management
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Assessment method [11]
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Anti-psychotic (defined daily dose equivalent) medication administration, assessed via audit of medical records
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Timepoint [11]
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Days 1, 2, 3, 4, 5, 6, 7 post baseline
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Secondary outcome [12]
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Physical and social health
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Assessment method [12]
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Patient-Reported Outcomes Measurement Information System (PROMIS-29)
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Timepoint [12]
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Days 7, 14, 21, 28, 56, 84 post baseline
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Secondary outcome [13]
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Post-withdrawal medication use
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Assessment method [13]
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Use of ancillary medications post-withdrawal, assessed by self report
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Timepoint [13]
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Days 14, 21, 28, 56, 84 post baseline
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Eligibility
Key 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 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be based on a study ID allocated to each participant after they have been confirmed eligible. Trial medication will be dispensed and allocated according to the study ID contained in the randomisation schedule, which will be generated by an independent statistician and held by the trial site pharmacy.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in a 1:1 ratio between groups using variable block randomisation (to help maintain allocation concealment), stratified by site. Electronic randomisation procedures will be conducted by study staff on a REDCap interactive web response system.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
A statistical analysis plan will be developed and overseen by staff at the University of New South Wales conducting analysis (providing externally contracted statistical support). All outcome variables will be analysed on intention-to-treat principles, and missing data imputed using multiple imputation. A likelihood-based mixed model repeated measures approach will be used to analyse the primary efficacy measure of between-group difference in average AWQ score over 7 days from Baseline. Survival analysis using Cox proportional hazards regression will compare retention in protocol by adherence to study drug (to Day 5), and inpatient treatment (to Day 7) between study arms, adjusting for potential predictors (e.g., age, baseline frequency of methamphetamine use). For categorical measures such as the presence of adverse events, differences in rates between groups will be analysed using logistic regression.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
14/10/2024
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Actual
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Date of last participant enrolment
Anticipated
30/09/2026
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Actual
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Date of last data collection
Anticipated
31/12/2026
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Actual
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Sample size
Target
184
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St Vincent's Hospital (Darlinghurst) - Darlinghurst
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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NHMRC
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Address [1]
317065
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Country [1]
317065
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Australia
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Primary sponsor type
Hospital
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Name
St Vincent's Hospital Sydney
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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None
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Address [1]
319314
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Country [1]
319314
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Other collaborator category [1]
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University
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Name [1]
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University of New South Wales
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Address [1]
283122
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Country [1]
283122
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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St Vincent’s Hospital Human Research Ethics Committee
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Ethics committee address [1]
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https://svhs.org.au/home/research-education/research-office
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Ethics committee country [1]
315813
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Australia
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Date submitted for ethics approval [1]
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22/04/2024
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Approval date [1]
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15/05/2024
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Ethics approval number [1]
315813
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2024/ETH00788
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Nadine Ezard
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Address
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St Vincent's Hospital Sydney, 390 Victoria St Darlinghurst NSW 2010
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Country
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Australia
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Phone
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+61 2 83821012
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Liam Acheson
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Address
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St Vincent's Hospital Sydney 390 Victoria St Darlinghurst NSW 2010
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Country
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Australia
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Phone
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+61 2 90657809
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Nadine Ezard
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Address
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St Vincent's Hospital Sydney, 390 Victoria St Darlinghurst NSW 2010
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Country
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Australia
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Phone
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+61 2 83821012
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Demographic and trial outcome data in a non-identifiable manner
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When will data be available (start and end dates)?
Immediately following publication of results - no end date determined
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Available to whom?
Due to the sensitive nature of the sample, data will be made avaliable on a case by case basis as determined by the principal investigator
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Available for what types of analyses?
Only to achieve aims in the primary proposal
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How or where can data be obtained?
Subject to approval from the principal investigator (
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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