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Trial registered on ANZCTR
Registration number
ACTRN12624000269538
Ethics application status
Approved
Date submitted
5/01/2024
Date registered
18/03/2024
Date last updated
18/03/2024
Date data sharing statement initially provided
18/03/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Improving care of attention deficit hyperactivity disorder (ADHD) in people who use drugs
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Scientific title
Managing substance use disorder (SUD) in the presence of Attention Deficit Hyperactivity Disorder (ADHD): does active management of ADHD improve outcomes in terms of reduced drug use and improved quality of life?
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Secondary ID [1]
311261
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NONE
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder (ADHD)
332482
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substance use disorder (SUD)
332483
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Condition category
Condition code
Mental Health
329174
329174
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0
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Addiction
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Mental Health
329175
329175
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The subjects will be divided randomly on enrolment into tow groups.
Group A will be immediately be provided with additional services including case management, counselling, access to ADHD coaching, and a mental health review with a psychiatrist. A research nurse will provide case management. All contacts and reviews (including telehealth review) will be recorded.
Group B will be offered all the additional services after 6 months of treatment as usual.
Treatment as usual consists of assessment by an addiction medicine specialist, psychiatric registrar or psychiatrist who prescribes medication, provides psychoeducation and reviews the patients as required.
The additional services include:
(a) case management by a nurse or alcohol and other drug case worker includes monitoring adherence and issuing reminders to ensure partiipation
(b) access to coaching by a qualified ADHD coach (typically 10 weekly one hour sessions)
(c) formal review of comorbid mental health issues by an independent psychiatrist
(d) regular review (at least monthly) by the research nurse or an addiction medicine or addiction psychiatry consultant
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Intervention code [1]
327713
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Treatment: Other
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Intervention code [2]
327714
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Behaviour
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Intervention code [3]
327715
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Lifestyle
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Comparator / control treatment
Treatment as usual is characterised by psychoeducation and treatment with psychostimulants. The subject is seen at regular intervals (usually monthly) for review. Patients are told of additional services such as psychological strategies and coaching, but as engagement requires the subject to actively ‘opt in’. This is the control group for the study.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in ADHD symptoms
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Assessment method [1]
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Adult ADHD Self Report Scale (ASRS)
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Timepoint [1]
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Baseline and three monthly for 6 months Group A and 12 months Group B
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Primary outcome [2]
337023
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Change in ADHD related impairment
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Assessment method [2]
337023
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Weiss Impairment Scale
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Timepoint [2]
337023
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Baseline and three monthly for 6 months Group A and 12 months Group B
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Primary outcome [3]
337024
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Change in substance use
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Assessment method [3]
337024
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Change in Australian Treatment Outcome Profile
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Timepoint [3]
337024
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Baseline and three monthly for 6 months Group A and 12 months Group B
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Secondary outcome [1]
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Change in reported Quality of Life
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Assessment method [1]
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WHO Quality of Life Scale - Brief
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Timepoint [1]
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Baseline and end of intervention (6 months for Group A and 12 months for Group B)
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Secondary outcome [2]
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Change in psychological functioning - as assessed by the Loffty inventory
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Assessment method [2]
430396
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Loffty inventory
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Timepoint [2]
430396
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Baseline and three monthly for 6 months Group A and 12 months Group B
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Secondary outcome [3]
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Change in depression, anxiety and stress
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Assessment method [3]
430998
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DASS-21
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Timepoint [3]
430998
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Baseline and three monthly for 6 months Group A and 12 months Group B
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Secondary outcome [4]
432385
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Change in compensatory behaviours
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Assessment method [4]
432385
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Compensatory ADHD Behaviours Scale (CABS)
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Timepoint [4]
432385
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Baseline and three-monthly Group A and at 12 months Group B
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Eligibility
Key inclusion criteria
Aged 18 year or over
Score >= 14 on ASRS part A
Have the diagnosis confirmed on interview (DIVA)
Live within the Goulburn Valley Health catchment area
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Have a history of
o Severe neurological disorders including stroke
o Symptomatic cardiovascular disease
o Hyperthyroidism
o Moderate to severe hypertension
o Glaucoma
o Pheochromocytoma
o Have a current acute psychotic illness
o using mono-amine oxidase inhibitors
o Are pregnant or breastfeeding at recruitment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation at presentation using a simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
3/01/2024
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Date of last participant enrolment
Anticipated
30/06/2025
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
80
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Accrual to date
12
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
315516
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Charities/Societies/Foundations
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Name [1]
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Victoria Alcohol and Drug Association (VAADA)
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Address [1]
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211 Victoria Parade, Collingwood VIC 3066
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Country [1]
315516
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Australia
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Primary sponsor type
Government body
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Name
Alcohol and Drug Research Innovation Agenda (ADRIA)
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Address
211 Victoria Parade, Collingwood VIC 3066
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Country
Australia
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Secondary sponsor category [1]
317600
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Hospital
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Name [1]
317600
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Goulburn Valley Alcohol and Drug Service
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Address [1]
317600
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121 Corio Street, Shepparton Vic 3630
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Country [1]
317600
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314419
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Goulburn Valley Health Human Research Ethics Committee
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Ethics committee address [1]
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http://www.gvhealth.org.au/about-us/research-and-ethics/
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Ethics committee country [1]
314419
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Australia
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Date submitted for ethics approval [1]
314419
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09/10/2023
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Approval date [1]
314419
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17/11/2023
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Ethics approval number [1]
314419
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Summary
Brief summary
ADHD is a common neurodevelopmental disorder defined by the persistence of dysregulated attention, activity and impulsivity. The incidence of ADHD in childhood is 6-7%. Some symptoms improve in adolescence, but 2–4% of adults continue to meet the diagnostic criteria.
ADHD is recognised in 3 to 4 times as many people seeking help for substance use disorder (SUD) as in the general population. Adults with ADHD who use drugs are often misdiagnosed and cannot access effective, targeted, multidisciplinary care. Individual specialists and specialist services will not treat ADHD in the presence of SUD.
This project aims to demonstrate that recognition of ADHD and active management significantly improve quality of life and reduce substance use in people seeking help for SUD.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Professor Edward Ogden PSM
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Address
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Goulburn Valley Alcohol and Drug Servce, 121-135 Corio Street, Shepparton VIC 3630
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Country
131510
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Australia
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Phone
131510
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+61 3 5823 7974
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Fax
131510
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Email
131510
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[email protected]
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Contact person for public queries
Name
131511
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Prof Professor Edward Ogden PSM
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Address
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Goulburn Valley Alcohol and Drug Servce, 121-135 Corio Street, Shepparton VIC 3630
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Country
131511
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Australia
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Phone
131511
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+61 3 5823 7974
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Fax
131511
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Email
131511
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[email protected]
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Contact person for scientific queries
Name
131512
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Prof Professor Edward Ogden PSM
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Address
131512
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Goulburn Valley Alcohol and Drug Servce, 121-135 Corio Street, Shepparton VIC 3630
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Country
131512
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Australia
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Phone
131512
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+61 3 5823 7974
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Fax
131512
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Email
131512
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
No additional documents have been identified.
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