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Trial registered on ANZCTR


Registration number
ACTRN12621000045819
Ethics application status
Approved
Date submitted
11/11/2020
Date registered
18/01/2021
Date last updated
18/01/2021
Date data sharing statement initially provided
18/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An open-label, safety and feasibility pilot study of tapering lisdexamfetamine for adult methamphetamine withdrawal inpatients
Scientific title
An open-label, safety and feasibility pilot study of tapering lisdexamfetamine for adult methamphetamine withdrawal inpatients
Secondary ID [1] 302774 0
None
Universal Trial Number (UTN)
U1111-1261-0842
Trial acronym
OLAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute methamphetamine withdrawal 319717 0
Condition category
Condition code
Mental Health 317647 317647 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lisdexamfetamine (Vyvanse)
Dose: Tapering dose of 250mg once daily on Day 1 reducing by 50mg per day until 50mg on Day 5
Duration: 5 days
Mode: Oral tablet
Adherence: Dosing will be supervised by qualified nursing staff and entered into the participant medication chart. Any refused or un-taken doses will be noted in the participant medication chart
Intervention code [1] 319051 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325698 0
To determine the safety of delivering a five-day tapering dose regimen of lisdexamfetamine (LDX) for the treatment of acute methamphetamine (MA) withdrawal in inpatients as measured by the number and severity of adverse events recorded in the participant medical record
Timepoint [1] 325698 0
Day 5 post commencement of dosing
Primary outcome [2] 325994 0
To determine the feasibility of delivering a five-day tapering dose regimen of lisdexamfetamine (LDX) for the treatment of acute methamphetamine (MA) withdrawal in inpatients. Tools used to assess this outcome will be 1) the time taken to enroll sample (weeks and months to achieve recruitment of target sample) and the proportion of screen failures as collected in study records (based on eligibility criteria)
Timepoint [2] 325994 0
Baseline to study completion
Secondary outcome [1] 388789 0
To describe the acceptability of a five-day tapering dose regimen of LDX for the treatment of acute MA withdrawal in treatment-seeking patients as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM II), medication adherence (e.g. number of prescribed LDX doses taken) and concomitant medications recorded
Timepoint [1] 388789 0
Day 5 post commencement of dosing
Secondary outcome [2] 388790 0
To describe participant retention to the study protocol reported at Days 5, 7, 14, 21 and 28. Measured as average number of days until participant discharge or withdrawal from study as collected in study database. Data reported separately and in composite.
Timepoint [2] 388790 0
Day 5, Day 7, Day 14, Day 21, Day 28 post commencement of dosing
Secondary outcome [3] 388791 0
To describe the changes in withdrawal severity associated with a five-day tapering dose regimen of LDX in people acutely withdrawing from MA as measured by change in subjective withdrawal severity (Amphetamine Withdrawal Questionnaire [AWQ])
Timepoint [3] 388791 0
Baseline, Day 5, Day 7, Day 28 post commencement of dosing
Secondary outcome [4] 388792 0
To describe the sleep-wake cycle of people with acute MA withdrawal in an inpatient withdrawal setting receiving a five-day tapering dose regimen of LDX as measured by continuous actigraphy and subjective sleep diary (Consensus Sleep Diary)
Timepoint [4] 388792 0
Day 1, Day 2, Day 3, Day 4, Day 5 post commencement of dosing
Secondary outcome [5] 389870 0
To describe the changes in craving associated with a five-day tapering dose regimen of LDX in people acutely withdrawing from MA as measured by change in craving (Visual Analogue Scale [VAS]) over time.
Timepoint [5] 389870 0
Baseline, Day 5, Day 7, Day 28 post commencement of dosing

Eligibility
Key inclusion criteria
• Adults over the age of 18 years
• Presenting to inpatient drug treatment services seeking treatment for acute MA withdrawal
• Methamphetamine use disorder as determined by an addiction medicine specialist according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Criteria
• Last MA use within 72 hours of planned first study drug dose
• Have a positive urine drug screen for methamphetamines
• Willing and able to provide written informed consent and willingness to participate in and comply with the study
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study
• Expected concurrent withdrawal from alcohol, opioids, benzodiazepines, gamma-hydroxybutyrate or other gabapentinoids
• Known contradictions to lisdexamfetamine
• Medically significant condition which in the opinion of a study medical officer renders a patient unsuitable for the study
• Involuntary patients (e.g. under the Mental Health Act in NSW

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety
Statistical methods / analysis
This is a pilot study and as such no power calculations have been completed. The study will enroll 15 participants, conventional for an open-label single-arm study.
Primary and secondary outcomes will be analysed using descriptive statistics. Continuous measures such as mean changes in withdrawal and craving scores from Baseline to Day 5 Day 7 and Day 28 will be analysed. For categorical measures such as the presence of adverse events, rates will be analysed using chi-square and relative risk.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18003 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 31971 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 307191 0
Other Collaborative groups
Name [1] 307191 0
The National Centre for Clinical Research on Emerging Drugs
Address [1] 307191 0
Care of the University of New South Wales National Drug and Alcohol Research Centre, 22-32 King St, Randwick, NSW, 2031 or St Vincent's Hospital, Sydney, 390 Victoria St, Darlinghurst, NSW, 2010
Country [1] 307191 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney
Address
390 Victoria St, Darlinghurst, NSW, Australia, 2010
Country
Australia
Secondary sponsor category [1] 307797 0
None
Name [1] 307797 0
Address [1] 307797 0
Country [1] 307797 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307300 0
St Vincent's Hospital Sydney Human Research Ethics Committee
Ethics committee address [1] 307300 0
Translational Research Centre, 97-105 Boundary St, Darlinghurst, NSW, 2010
Ethics committee country [1] 307300 0
Australia
Date submitted for ethics approval [1] 307300 0
03/08/2020
Approval date [1] 307300 0
22/10/2020
Ethics approval number [1] 307300 0
2020/ETH02039

Summary
Brief summary
This trial is an open-label, single-arm safety and feasibility trial of lisdexamfetamine for the management of acute methamphetamine withdrawal. Participants presenting for inpatient management of methamphetamine withdrawal will receive a tapering dose of lsidexamfetamine, starting at 250mg on day 1, reducing by 50mg per day to 50mg on day 5. Participants will be encouraged to remain in treatment for another two days for ongoing monitoring and will be followed up weekly for three weeks post discharge. We hypothesise that lisdexamfetamine is safe and feasible for the management of acute methamphetamine withdrawal.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106746 0
Dr Krista Siefried
Address 106746 0
O'Brien Centre, St. Vincent's Hospital, 390 Victoria St Darlinghurst, NSW, 2010
Country 106746 0
Australia
Phone 106746 0
+61 2 9065 7808
Fax 106746 0
Email 106746 0
krista.siefried@svha.org.au
Contact person for public queries
Name 106747 0
Mr Liam Acheson
Address 106747 0
O'Brien Centre, St. Vincent's Hospital, 390 Victoria St Darlinghurst, NSW, 2010
Country 106747 0
Australia
Phone 106747 0
+61 2 9065 7809
Fax 106747 0
Email 106747 0
liam.acheson@svha.org.au
Contact person for scientific queries
Name 106748 0
Dr Krista Siefried
Address 106748 0
O'Brien Centre, St. Vincent's Hospital, 390 Victoria St Darlinghurst, NSW, 2010
Country 106748 0
Australia
Phone 106748 0
+61 2 9065 7808
Fax 106748 0
Email 106748 0
krista.siefried@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the small recruitment numbers data will only be made available in aggregate to ensure participant anonymity. Databases for analysis will be available to peer reviewers
What supporting documents are/will be available?
No other documents available
Summary results
No Results