Methylphenidate sustained release in methamphetamine use disorder a safety study

Methylphenidate sustained release in methamphetamine use disorder – a pilot, open label, safety study

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000880943

Enrollment

Registered

2020-09-04

Start date

2020-10-05

Completion date

Unknown

Last updated

2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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.

Outcome results