Lisdexamfetamine for the treatment of methamphetamine addiction
A randomised double blind placebo controlled study of lisdexamfetamine for the treatment of methamphetamine dependence
University of New South Wales
180 participants
May 21, 2018
Interventional
Conditions
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
Inclusion Criteria8
- Provide written, informed consent to participate in the study.
- Aged 18 to 65 years
- Be treatment seeking for methamphetamine use
- Meet ICD-10 criteria for methamphetamine dependence for at least twelve months
- Self-report methamphetamine use of at least 14 days out of the previous 28
- Have one urine drug screen (UDS) positive for methamphetamine within 7 days prior to registration
- Participants must have the ability to store study medication securely
- Be willing and able to comply with requirements of study
Exclusion Criteria14
- Current effective counselling based treatment for methamphetamine dependence
- Current pharmacotherapy treatment for opioid dependence
- Use of prescribed dexamphetamine or modafinil in the previous four weeks
- 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.
- Currently lactating or pregnant, or of childbearing potential and not willing to avoid becoming pregnant during the study
- Sensitivity or previous adverse reaction to lisdexamfetamine
- Current, severe medical disorder (e.g. Cardiovascular disease, uncontrolled hypertension, peripheral vascular disease, assessed by study medical officer)
- 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)
- History of glaucoma, hyperthyroidism, pheochromocytoma, motor tics, vocal tics or Tourette’s syndrome
- 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.
- 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
- Not available for follow-up (e.g. Likely travel or imprisonment)
- Undergoing child protection service/court/work ordered drug testing
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Interventions
Week 1 (Induction): 150mg lisdexamfetamine capsules taken orally, daily Weeks 2-13 (Maintenance phase): 250mg lisdexamfetamine capsules taken orally, daily Weeks 14-15 (Reduction): 150mg lisdexamfetamine capsules taken orally, daily for 1 week, then 50mg lisdexamfetamine capsules daily taken orally,daily for a further week Oral lisdexamfetamine dimesylate 50 mg capsules and placebo capsules will be used to make up the prescribed study dose. Trial medications will be obtained, prepacked in child resistant blister packs, stored and shipped to participating sites by a contracted Good Manufacturing Practice registered facility in accordance with the Poisons and Therapeutic Goods Act 1966 and the Poisons and Therapeutic Goods Regulation 2008. The active drug (lisdexamfetamine dimesylate) and the placebo shall be provided in identical capsules to ensure the study blind. The GMP facility shall package and label the study medication in boxes and ship to the relevant pharmacy departments. Each box shall include the name and strength of the drug along with all other warnings and instructions necessary to fulfil the requirements of the Poisons and Therapeutic Goods Act 1966 and the Poisons and Therapeutic Goods Regulation 2008 Each box shall be dispended by a pharmacist and provided to an appropriately qualified nurse, who will supervise the administration of the medication to the participant. The participant will take home the box containing the remainder of the medication. At initial research interview, participants will be counselled on strategies to promote medication adherence using a modified version of the COMBINE to draw up an initial medication adherence plan check which will be conducted at subsequent research assessments. Adherence will be assessed through self-report and pill counts and conduct counselling to promote adherence using the brief medication adherence check session worksheet.
Locations(6)
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ACTRN12617000657325