A randomised double blind placebo controlled study of lisdexamfetamine for the treatment of methamphetamine dependence

niversity of New South Wales0 sites155 target enrollmentMay 8, 2017

Overview

No summary available.

Registry

who.int

Start Date

May 8, 2017

End Date

December 22, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\.Provide written, informed consent to participate in the study.
•2\.Aged 18 to 65 years
•3\.Be treatment seeking for methamphetamine use
•4\.Meet ICD\-10 criteria for methamphetamine dependence for at least twelve months
•5\.Self\-report methamphetamine use of at least 14 days out of the previous 28
•6\.Have one urine drug screen (UDS) positive for methamphetamine within 7 days prior to registration
•7\.Participants must have the ability to store study medication securely
•8\.Be willing and able to comply with requirements of study

•9\.Current effective counselling based treatment for methamphetamine dependence
•10\.Current pharmacotherapy treatment for opioid dependence
•11\.Use of prescribed dexamphetamine or modafinil in the previous four weeks
•12\.Current dependent use of alcohol or non\-prescribed substances other than amphetamines, diagnosed by specialist clinical assessment against ICD\-10 criteria, which in the opinion of the investigator would interfere with participation in the study.
•13\.Currently lactating or pregnant, or of childbearing potential and not willing to avoid becoming pregnant during the study
•14\.Sensitivity or previous adverse reaction to lisdexamfetamine
•15\.Current, severe medical disorder (e.g. Cardiovascular disease, uncontrolled hypertension, peripheral vascular disease, assessed by study medical officer)
•16\.Current, severe psychiatric disorder (e.g. Acute psychosis, severe anxiety and/or mood disorder, intent to harm self or others assessed by study medical officer and/or psychiatrist)
•17\.History of glaucoma, hyperthyroidism, pheochromocytoma, motor tics, vocal tics or Tourette’s syndrome
•18\.Use of monoamine oxidase inhibitors in previous 14 days; or use of other medications that could interact with study medication on assessment by the investigator.