Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000391572
Ethics application status
Approved
Date submitted
8/04/2015
Date registered
28/04/2015
Date last updated
19/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Dose-escalating, phase 2 study of oral lisdexamfetamine in adults with methamphetamine dependence
Scientific title
Dose-escalating, phase 2 safety study of oral lisdexamfetamine in adults with methamphetamine dependence
Secondary ID [1] 286473 0
Nil
Universal Trial Number (UTN)
U1111-1169-0817
Trial acronym
Lisdex
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Methamphetamine Dependence 294661 0
Condition category
Condition code
Mental Health 294962 294962 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study period extends over 14 weeks, which includes a 2 week screening period, 8 weeks of treatment, and a follow up visit 4 weeks after the final dose has been administered. Dose-escalating study of oral lisdexamfetamine from a minimum of 100mg/day to a maximum of 250mg/day and then decreased over the 8 week treatment period to establish safety profile in adults with methamphetamine dependence. Study drug to be dispensed daily at study site drug treatment centre. Participants and dispensing staff will be aware of dose-escalation, but will be blinded as to when dose is escalated to reduce expectancy effects. Participants will also be offered weekly counseling, but participation in the trial is not contingent on this.
Intervention code [1] 291583 0
Treatment: Drugs
Comparator / control treatment
Phase 2 study without control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294737 0
Safety of ascending dose of lisdexamfetamine by monitoring adverse events diagnosed by physician. Blood pressure and pulse are monitored daily, and weekly screening for symptoms of psychosis using the Brief Psychiatric Rating Scale (hostility and psychosis items). Other psychiatric symptoms will be screened for using the PHQ-9 and the GAD-7. Other somatic symptoms will be screened for using the PHQ-15. Insomnia will be screened for with the Insomnia Severity Index. Changes in other substance use will be screened for by Time Line Followback questionnaires. Neurocognitive testing will be undertaken to assess for changes in neurocognition.
Timepoint [1] 294737 0
Week 4
Primary outcome [2] 294738 0
Tolerability of ascending dose of lisdexamfetamine by assessing monitoring for adverse events diagnosed by physician which are not safety related, as well as using Drug Effects Questionnaire 5 (DEQ-5, Acute Subjective Response to Substances (amphetamine) questionnaire, Treatment Satisfaction Questionnaire for Medication.
Timepoint [2] 294738 0
Week 4
Primary outcome [3] 294739 0
Adherence to the drug regimen will be assessed by completion rate by participants
Timepoint [3] 294739 0
Week 4
Secondary outcome [1] 313965 0
Change in methamphetamine use will be assessed by patient self-reported use of methamphetamine by TimeLine Follow-back questionnaire, and by urine drug screen.
Timepoint [1] 313965 0
Week 4, Week 8, Week 12
Secondary outcome [2] 313966 0
Change in craving symptoms as assessed by 100mm Visual Analogue scale with the question "How much do you crave methamphetamine at the moment?"
Timepoint [2] 313966 0
Week 4, Week 8, Week 12
Secondary outcome [3] 313967 0
Change in self-reported HIV/BBS/STI risk behaviours assessed by using the adapted Opiate Treatment Index crime and injecting questions 1 to 4 subscales.
Timepoint [3] 313967 0
Week 4 and 12
Secondary outcome [4] 313968 0
Participant rating of dose adequecy using self-reported Price would Pay and Craving Visual Analogue Scale.
Timepoint [4] 313968 0
Week 4, Week 8 and Week 12
Secondary outcome [5] 314086 0
Change in withdrawal symptoms assessed by Amphetamine Withdrawal Questionnaire
Timepoint [5] 314086 0
Week 4, Week 8 and Week 12
Secondary outcome [6] 314091 0
Medication acceptability as assesed by self-reported Treatment Satisfaction Questionnaire for Medication
Timepoint [6] 314091 0
Week 4, Week 8 and Week 12
Secondary outcome [7] 314092 0
Adherence to study protocol as assessed by attendance to study visits
Timepoint [7] 314092 0
Week 4, Week 8 and Week 12

Eligibility
Key inclusion criteria
- Treatment seeking for Methamphetamine (MA) dependence
- Fulfils ICD-10 criteria for MA dependence
- Self-reported MA use of >/= 14 days out of 28 days prior to enrolment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Use of dexamphetamine in the previous 4 weeks
- Uncontrolled medical or psychiatric conditions
- Unstable alcohol or other substance use, other than MA
- Pregnant or nursing females
- Moderate to severe hypertension
- Sensitivity/allergy to lisdexamfetamine

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolled participants and drug administration personnel will be aware that the dose of the study drug will be escalated and reduced over 8 weeks, but will be blinded as to when dose will be changed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Other
Other design features
All participants are to receive a escalating dose of the study drug through the trial.
Phase
Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/05/2015
Actual
15/06/2015
Date of last participant enrolment
Anticipated
Actual
29/11/2016
Date of last data collection
Anticipated
Actual
20/12/2016
Sample size
Target
20
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3674 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 3675 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment postcode(s) [1] 9503 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 9504 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 291054 0
Government body
Name [1] 291054 0
NSW Health
Country [1] 291054 0
Australia
Primary sponsor type
Hospital
Name
St. Vincent's Hospital, Sydney
Address
390 Victoria Street
Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 289737 0
Government body
Name [1] 289737 0
Hunter New England Local Health District
Address [1] 289737 0
Drug & Alcohol Clinical Services
Newcastle Community Health Centre
Suite 8, Level 3, 670 Hunter St
Newcastle NSW 2300
Country [1] 289737 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292637 0
St. Vincent's Hosptial, Sydney Human Research Ethics Committee
Ethics committee address [1] 292637 0
Level 6, de Lacy Building
St Vincent’s Hospital
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 292637 0
Australia
Date submitted for ethics approval [1] 292637 0
Approval date [1] 292637 0
04/09/2014
Ethics approval number [1] 292637 0
14/SVH/202

Summary
Brief summary
There are currently no approved pharmacological treatments for methamphetamine dependence. There is a theoretical basis that drugs similar to methamphetamine, such lisdeamfetamine, may allow dependent users to stablise their use. Currently, there is no data on what dose of lisdexamfetamine is safe for people who are habituated to methamphertamine use. This study aims to ascertain the safety of giving a higher dose, while also looking for any change in methamphetine use or risk behaviours while taking the study drug.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56282 0
A/Prof Nadine Ezard
Address 56282 0
Alcohol & Drug Service
St. Vincent's Hospital
Level 4 O'Brien Centre
Victoria & Burton Streets
Darlinghurst NSW 2010
Country 56282 0
Australia
Phone 56282 0
+61 2 83821014
Fax 56282 0
Email 56282 0
nadine.ezard@svha.org.au
Contact person for public queries
Name 56283 0
Ms Sianne Hodge
Address 56283 0
Alcohol & Drug Service
St. Vincent's Hospital
Level 4 O'Brien Centre
Victoria & Burton Streets
Darlinghurst NSW 2010
Country 56283 0
Australia
Phone 56283 0
+ 61 2 83821014
Fax 56283 0
Email 56283 0
sianne.hodge@svha.org.au
Contact person for scientific queries
Name 56284 0
A/Prof Nadine Ezard
Address 56284 0
Alcohol & Drug Service
St. Vincent's Hospital
Level 4 O'Brien Centre
Victoria & Burton Streets
Darlinghurst NSW 2010
Country 56284 0
Australia
Phone 56284 0
+ 61 2 83821014
Fax 56284 0
Email 56284 0
nadine.ezard@svha.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol: A dose-escalating, phase-2 study of oral lisdexamfetamine in adults with methamphetamine dependence.2016https://dx.doi.org/10.1186/s12888-016-1141-x
EmbaseSafety and tolerability of oral lisdexamfetamine in adults with methamphetamine dependence: A phase-2 dose-escalation study.2021https://dx.doi.org/10.1136/bmjopen-2020-044696
N.B. These documents automatically identified may not have been verified by the study sponsor.