Trial Review

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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
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?
Secondary ID [1] 311261 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder (ADHD) 332482 0
substance use disorder (SUD) 332483 0
Condition category
Condition code
Mental Health 329174 329174 0 0
Addiction
Mental Health 329175 329175 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 327713 0
Treatment: Other
Intervention code [2] 327714 0
Behaviour
Intervention code [3] 327715 0
Lifestyle
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.
Control group
Active

Outcomes
Primary outcome [1] 337022 0
Change in ADHD symptoms
Timepoint [1] 337022 0
Baseline and three monthly for 6 months Group A and 12 months Group B
Primary outcome [2] 337023 0
Change in ADHD related impairment
Timepoint [2] 337023 0
Baseline and three monthly for 6 months Group A and 12 months Group B
Primary outcome [3] 337024 0
Change in substance use
Timepoint [3] 337024 0
Baseline and three monthly for 6 months Group A and 12 months Group B
Secondary outcome [1] 430392 0
Change in reported Quality of Life
Timepoint [1] 430392 0
Baseline and end of intervention (6 months for Group A and 12 months for Group B)
Secondary outcome [2] 430396 0
Change in psychological functioning - as assessed by the Loffty inventory
Timepoint [2] 430396 0
Baseline and three monthly for 6 months Group A and 12 months Group B
Secondary outcome [3] 430998 0
Change in depression, anxiety and stress
Timepoint [3] 430998 0
Baseline and three monthly for 6 months Group A and 12 months Group B
Secondary outcome [4] 432385 0
Change in compensatory behaviours
Timepoint [4] 432385 0
Baseline and three-monthly Group A and at 12 months Group B

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/01/2024
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
80
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315516 0
Charities/Societies/Foundations
Name [1] 315516 0
Victoria Alcohol and Drug Association (VAADA)
Country [1] 315516 0
Australia
Primary sponsor type
Government body
Name
Alcohol and Drug Research Innovation Agenda (ADRIA)
Address
211 Victoria Parade, Collingwood VIC 3066
Country
Australia
Secondary sponsor category [1] 317600 0
Hospital
Name [1] 317600 0
Goulburn Valley Alcohol and Drug Service
Address [1] 317600 0
121 Corio Street, Shepparton Vic 3630
Country [1] 317600 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314419 0
Goulburn Valley Health Human Research Ethics Committee
Ethics committee address [1] 314419 0
Ethics committee country [1] 314419 0
Australia
Date submitted for ethics approval [1] 314419 0
09/10/2023
Approval date [1] 314419 0
17/11/2023
Ethics approval number [1] 314419 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131510 0
Prof Professor Edward Ogden PSM
Address 131510 0
Goulburn Valley Alcohol and Drug Servce, 121-135 Corio Street, Shepparton VIC 3630
Country 131510 0
Australia
Phone 131510 0
+61 3 5823 7974
Fax 131510 0
Email 131510 0
edward.ogden@gvhealth.org.au
Contact person for public queries
Name 131511 0
Professor Edward Ogden PSM
Address 131511 0
Goulburn Valley Alcohol and Drug Servce, 121-135 Corio Street, Shepparton VIC 3630
Country 131511 0
Australia
Phone 131511 0
+61 3 5823 7974
Fax 131511 0
Email 131511 0
edward.ogden@gvhealth.org.au
Contact person for scientific queries
Name 131512 0
Professor Edward Ogden PSM
Address 131512 0
Goulburn Valley Alcohol and Drug Servce, 121-135 Corio Street, Shepparton VIC 3630
Country 131512 0
Australia
Phone 131512 0
+61 3 5823 7974
Fax 131512 0
Email 131512 0
edward.ogden@gvhealth.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.