Clinical Trial Details

Lisdexamfetamine for the treatment of methamphetamine addiction

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Trial Information

Broad Health Condition Mental Health

Specific Health ConditionAddiction

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,SA,VIC

Hospital
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Cumberland Hospital - Westmead
Turning Point Drug and Alcohol Centre - Richmond
Drug and Alcohol Clinical Services, Hunter New England Local Health District - Newcastle
Drug & Alcohol Services South Australia (DASSA) - Stepney


Postcode
2010 - Darlinghurst
2145 - Westmead
5069 - Stepney
3121 - Richmond
2300 - Newcastle

Anticipated date of first participant enrolment21/05/2018

Anticipated date of last participant enrolment21/05/2018

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Trial summary

Australia has one of the highest rates of methamphetamine dependence in the world. While counselling is effective for many people with less severe dependence, there is no proven medication treatment for severe dependence. 

Lisdexamfetamine is a stimulant of the brain and is approved in Australia for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).  It is a once-daily oral medication converted to dexamphetamine in the blood.  

The aim of the LiMA study is to test if lisdexamfetamine is effective in reducing methamphetamine use, cravings and withdrawal symptoms in people who are dependent on methamphetamine. 

This will be a randomised double-blind placebo-controlled study which means that one group will receive lisdexamfetamine and another will receive a placebo (a medication with no active ingredients), in addition to counselling. Participants, clinicians and researchers involved in the study will not know to which group they have been allocated. The two groups will be compared and the findings will contribute to evidence for the future use of lisdexamfetamine in the treatment of methamphetamine dependence.

180 people will be recruited to the LiMA study which will be conducted in specialist treatment centres in Sydney, Newcastle and Adelaide. It is anticipated that recruitment will start in early 2017. 
Eligibility

Key inclusion criteria

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

Minimum age18 Years

Maximum age65 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

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. 
19.	Exposure to any investigational drug within the 4 weeks prior to screening 
Note: Co-enrolment in another study not involving an investigational drug is not an exclusion criterion, provided it does not cause undue burden on the participant or effect the ethical, safety, statistical, or practical requirements of this study as determined by the PI
20.	Not available for follow-up (e.g. Likely travel or imprisonment)
21.	Undergoing child protection service/court/work ordered drug testing
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Associate Professor Nadine Ezard
Primary Sponsor Address: St Vincent's Hospital Sydney 390 Victoria Street Darlinghurst NSW 2010
Primary Sponsor Country: Australia

Trial websitehttps://limastudy.info/

Trial IDACTRN12617000657325

UTNU1111-1195-2142

Contact person for information and recruitmentMs
Michelle Hall
Hunter New England Health Drug & Alcohol Clinical Services 670 Hunter Street, Newcastle, NSW, 2300
61 2 4016 4781

Further information iconmichelle.hall@hnehealth.nsw.gov.au
Australia