Methylphenidate sustained release in methamphetamine use disorder a safety study

Phase 1

• Conditions: Methamphetamine Use Disorder; Mental Health - Addiction

• Registration Number: ACTRN12620000880943
• Lead Sponsor: Christopher Gale

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-04
• Last Update Posted: 14 September 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participant Safety. <br><br>Patients will be stopped if:<br><br>1.The patient chooses to discontinue the medication – the reasons will be noted verbatim, and tabulated. <br>2.BP increases to over 170 mmHg systolic or 110 mmHg diastolic (using an automated syhyogmoanometer) assessed daily immediately before <br>3.QTc increases to over 450 milliseconds, raw or corrected on a 12 lead ECG <br>4.Acute chest pain, neurological symptoms, shortness of breath. <br>[BP and pulse: daily prior to dose and every half hour for five hours post dose for four consecutive day.<br>ECG: daily prior to dose.for 4 days Not measured after dosing. <br>Symptom checklist: evey day prior to dose for 4 days not measured after dosing. ]

Secondary Outcome Measures

Name	Time	Method
The screening for questions for psychosis from the CIDI [Daily prior to dose for four days immediately before doseing for four days. Not measured after dosing.];Depressive symptoms using Hamilton Depression Scale Not measured after dosing[Daily prior to dose for four days immediately before doseing for four days Not measured after dosing];Craving of stimulants using the Brief Craving Scale[Daily prior to dose for four days immediately before doseing for four days. Not measured after dosing];Elevated mood using the Young Mania Rating scale. Not measured after dosing[Daily prior to dose for four days immediately before doseing for four days Not measured after dosing]