isdexamfetamine for the treatment of methamphetamine addictio

Phase 3

Completed

• Conditions: Addiction; Methamphetamine dependence; Mental Health - Addiction

• Registration Number: ACTRN12617000657325
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-08
• Study Completion: 2021-12-22
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 155

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified