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Trial registered on ANZCTR


Registration number
ACTRN12620000880943p
Ethics application status
Not yet submitted
Date submitted
9/07/2020
Date registered
4/09/2020
Date last updated
4/09/2020
Date data sharing statement initially provided
4/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Methylphenidate sustained release in methamphetamine use disorder a safety study
Scientific title
Methylphenidate sustained release in methamphetamine use disorder – a pilot, open label, safety study
Secondary ID [1] 301698 0
Nil
Universal Trial Number (UTN)
U1111-1254-8331
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Methamphetamine Use Disorder 318150 0
Condition category
Condition code
Mental Health 316167 316167 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who have a DSM 5 diagnosis of Methamphetamine Use Disorder, if consented, will have serial doses of 56, 108, 164, and 216 mg of Methylphenidate sustained release (OROS methylphenidate) tablet with an increase in the dose used every day followed by five hours of post dose monitoring each day.

The dose will be administered as one dose daily after review of side effects, Blood Pressure had Heart rate, and a rapid urine drug screen. The dose will increase daily for four consecutive days.
Intervention code [1] 318002 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324348 0
Participant Safety.

Patients will be stopped if:

1. The patient chooses to discontinue the medication – the reasons will be noted verbatim, and tabulated.
2. BP increases to over 170 mmHg systolic or 110 mmHg diastolic (using an automated syhyogmoanometer) assessed daily immediately before
3. QTc increases to over 450 milliseconds, raw or corrected on a 12 lead ECG
4. Acute chest pain, neurological symptoms, shortness of breath.
Timepoint [1] 324348 0
BP and pulse: daily prior to dose and every half hour for five hours post dose for four consecutive day.
ECG: daily prior to dose.for 4 days Not measured after dosing.
Symptom checklist: evey day prior to dose for 4 days not measured after dosing.
Secondary outcome [1] 384408 0
The screening for questions for psychosis from the CIDI
Timepoint [1] 384408 0
Daily prior to dose for four days immediately before doseing for four days. Not measured after dosing.
Secondary outcome [2] 384409 0
Depressive symptoms using Hamilton Depression Scale Not measured after dosing
Timepoint [2] 384409 0
Daily prior to dose for four days immediately before doseing for four days Not measured after dosing
Secondary outcome [3] 384494 0
Craving of stimulants using the Brief Craving Scale
Timepoint [3] 384494 0
Daily prior to dose for four days immediately before doseing for four days. Not measured after dosing
Secondary outcome [4] 384495 0
Elevated mood using the Young Mania Rating scale. Not measured after dosing
Timepoint [4] 384495 0
Daily prior to dose for four days immediately before doseing for four days Not measured after dosing

Eligibility
Key inclusion criteria
(1) able to provide written informed consent;
(2) aged 18-65 years on the day of consent;
(3) Body Mass Index 17-35 kg/m2 at screening;
(4) meet DSM-5 criteria for methamphetamine use disorder as diagnosed using the PRISM (http://www.columbia.edu/~dsh2/prism/);
(5) Have a urine drug screen on day one that does not contain opiates, benzodiazepines, cannabinoids or stimulants.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of psychotic episodes, or evidence current or past psychosis on the PRISM
2. evidence from medical history of current significant or unstable cardiac or other medical conditions;
3. history of epilepsy, head trauma, or central nervous system diseases;
4. female patients who are pregnant or lactating;
5. participants who, in the opinion of the investigator, do not understand the information and procedures of the study, or would not be compliant with them.
6. Q-Tc of over 450 ms on 12 lead ECG
7. Premorbid ST changes consistent with previous ischaemia in 12 lead ECG.
8. A drug screen on any day that has more than methyphenidate in it.

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)
Open label
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a dose finding, open label, safety trial.
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety
Statistical methods / analysis
Most of the statistical plan is descriptive. We will tabulate the number of participants who completed all four days of the trial, the timing of any discontinuation, and the reason for discontinuation. We will graph the pooled data for each day over time. From previous work, we expect that there may be an increase in blood pressure and heart rate, which will decrease over time for each participant. We will compare the mean, median peak blood pressure, and heart rate by dose. We will report the interquartile range, and if the distribution is parametric, the standard deviation.

We will describe the mean results for the psychosis screener, Hamilton depression scale, Brief Craving scale and young mania rating scale.

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 outside Australia
Country [1] 22729 0
New Zealand
State/province [1] 22729 0
Otago

Funding & Sponsors
Funding source category [1] 306135 0
Charities/Societies/Foundations
Name [1] 306135 0
James Hume Memorial Fund
Address [1] 306135 0
James Hume Memorial Fund
Department of Psychological Medicine
Otago University Medical School Dunedin Campus
University of Otago
P. O. Box 913
Dunedin 9054
New Zealand
Country [1] 306135 0
New Zealand
Primary sponsor type
Individual
Name
Christopher Gale
Address
Department of Psychological Medicine
Otago Medical School Dunedin Campus
University of Otago
P. O. Box 913
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 306601 0
University
Name [1] 306601 0
University of Otago
Address [1] 306601 0
Otago Medical School Dunedin Campus
University of Otago
P. O. Box 913
Dunedin 9054
New Zealand
Country [1] 306601 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 306352 0
Central Health and Disability Ethics Committee or Southern Health and Disability Ethics Committee (work tends to be divided at submission between either of these committees
Ethics committee address [1] 306352 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 306352 0
New Zealand
Date submitted for ethics approval [1] 306352 0
10/09/2020
Approval date [1] 306352 0
Ethics approval number [1] 306352 0

Summary
Brief summary
This is an open label, pragmatic, dose finding study looking primarily at the safety of Methylphenidate OROS at doses used above those for treating ADHD. We would expect participants to abstain from using methamphetamine or methylphenidate for 24 hours prior to testing.

Patients who have a DSM 5 diagnosis of Methamphetamine Use Disorder, if consented, will have serial doses of 56, 108, 164, and 216 mg of Methylphenidate sustained release (OROS methylphenidate) with an increase in the dose used every day followed by five hours of post dose monitoring each day.

For the purposes of this pilot study, we will, pragmatically, recruit 10 participants.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103582 0
Dr Christopher Gale
Address 103582 0
Department of Psychological Medicine
Otago Medical School, Dunedin
P. O. Box 913
Dunedin 9054
Country 103582 0
New Zealand
Phone 103582 0
+64 2 1707193
Fax 103582 0
+64 3 4747934
Email 103582 0
chris.gale@otago.ac.nz
Contact person for public queries
Name 103583 0
Dr Christopher Gale
Address 103583 0
Department of Psychological Medicine
Otago Medical School, Dunedin
P. O. Box 913
Dunedin 9054
Country 103583 0
New Zealand
Phone 103583 0
+64 2 1707 193
Fax 103583 0
+64 3 4747934
Email 103583 0
chris.gale@otago.ac.nz
Contact person for scientific queries
Name 103584 0
Dr Christopher Gale
Address 103584 0
Department of Psychological Medicine
Otago Medical School, Dunedin
P. O. Box 913
Dunedin 9054
Country 103584 0
New Zealand
Phone 103584 0
+64 2 1707193
Fax 103584 0
+64 3 4747934
Email 103584 0
chris.gale@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The small size of the study and the open label/ safety design mean the data will not be suitable for meta analysis.
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 8437 0
Study protocol
Citation [1] 8437 0
Link [1] 8437 0
Email [1] 8437 0
chris.gale@otago.ac.nz
Other [1] 8437 0
Attachment [1] 8437 0
Type [2] 8438 0
Ethical approval
Citation [2] 8438 0
Link [2] 8438 0
Email [2] 8438 0
chris.gale@otago.ac.nz
Other [2] 8438 0
Attachment [2] 8438 0
Summary results
No Results