Plain English Summary
Background and study aims
Patients with substance use disorder (SUD) are three to four times more likely to have attention deficit/hyperactivity disorder (ADHD) compared to the general population. Standard treatments for ADHD has not proven to be as effective in comorbid patients as in patients with ADHD only. There is currently a lack of knowledge of how to best treat patients with comorbid ADHD-SUD.
The purpose of this study is to gain more knowledge regarding treatments provided, and treatment outcome for patients with ADHD and substance use disorder. The study is observational and the aim is to describe the natural course of the disorders, and to identify factors that might predict a successful treatment result, i.e. retention to treatment and reduction in ADHD and SUD symptoms.
Who can participate?
This study will invite 600 adult (≥18 years) treatment seeking patients with comorbid ADHD and SUD.
What does the study involve?
Participants will be asked for informed consent to provide self-reported data at the start of treatment, and after 3 and 9 months, respectively. Data from the patient files will be collected, e g to confirm whether a patient is still in treatment or not.
What are the possible benefits and risks of participating?
This a naturalistic study, observational study and participation does not affect the participants treatment in any way. Participants will not receive any compensation.
Where is the study run from?
The study is a multicentre international study from different countries in Europe, USA and Australia.
When is the study starting and how long is it expected to run for?
The study is is anticipated to go on between June 2017 and March 2022.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Christoffer Brynte
Physician, Stockholm Centre for Dependency Disorders
PhD student, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm
Christoffer.brynte@ki.se
Trial website
Contact information
Type
Scientific
Primary contact
Prof Johan Franck
ORCID ID
Contact details
Friskvårdsvägen 4
plan 2
S:t Göran
Stockholm
11281
Sweden
+46 (0)8 123 400 00
johan.franck@ki.se
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
INCAS: International Naturalistic Cohort Study of ADHD and Substance Use Disorders Study
Acronym
INCAS
Study hypothesis
The primary aim of the study is descriptive rather than hypothesis driven: To investigate the treatment modalitites provided to individuals with comorbid ADHD/SUD who are currently in treatment at SUD treatment services, and to identify predictors for successful treatment outcomes, as measured by retention, substance use and ADHD symptoms.
Ethics approval
Approved 16/06/2017, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02, Uppsala, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: 2017/973-32
Study design
Naturalistic multicenter observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Attention deficit hyperactivity/impulsivity disorder with comorbid substance use disorder
Intervention
This study is non-interventional and investigates the treatment modalities provided to the study population at the participating treatment services.
This study will invite 600 treatment-seeking patients from different countries in Europe, USA and Australia to participate for 9 months. Participants will be asked for informed consent to provide self-reported data at the start of treatment, and after 3 and 9 months, respectively. Data from the patient files will be collected, e.g. to confirm whether a patient is still in treatment or not. This a naturalistic study, observational study and participation does not affect the participants' treatment in any way.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Retention to treatment, defined as time to drop-out (last contact between patient and treatment center)
2. ADHD symptoms measured using the Adult ADHD Self-Report Scale (ASRS) at 3 months follow-up
3. Number of days with heavy alcohol use or days with illicit drug use during the last 30 days, measured using the Time-Line Follow-Back instrument at 3 months follow-up
4. ADHD symptoms measured with the Adult ADHD Self-Report Scale at 3 months follow-up
5. Number of days with heavy alcohol use or days of illicit drug use in the last 30 days, measured with Timeline Followback interview at 3 months follow-up
Secondary outcome measures
1. ADHD symptoms measured using the adult ASRS at 9 months follow-up
2. Substance use measured with TLFB, defined as the number of days with heavy alcohol use or days with illicit drug use the last 30 days at 9 months follow-up.
3. ADHD symptoms according to the Expanded Adult ADHD Self-Report Scale at 3 and 9 months follow-up, respectively
4. Employment measured using questionnaire and patient files at baseline, 3 months and 9 months
5. Number of accidents as reported by the participant using questionnaire and patient files at baseline, 3 months and 9 months
6. Days with any alcohol use during the last 30 days measured using Timeline Follow-Back interview at baseline, 3 months and 9 months follow-up
Overall trial start date
01/07/2016
Overall trial end date
31/03/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men and women ≥18 years of age seeking treatment for SUD at any of the participating sites
2. ADHD diagnosis according to DSM-5
3. SUD diagnosis (DSM-5 moderate to severe, ICD-10 dependence)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant exclusion criteria
There are no formal exclusion criteria except incapability to complete the assessments
Recruitment start date
01/07/2017
Recruitment end date
30/06/2021
Locations
Countries of recruitment
Australia, Belgium, France, Germany, Hungary, Netherlands, Spain, Sweden, Switzerland, United States of America
Trial participating centre
Stockholm Centre for Dependency Disorders
Friskvårdsvägen 4, plan 2, St:Göran
Stockholm
112 81
Sweden
Trial participating centre
Multiversum Boechout, Cadenza 2
Provinciesteenweg 408
Antwerpen
2530 Boechout
Belgium
Trial participating centre
Nyírő Gyula National Institute of Psychiatry and Addictions
Jász street 14
Budapest
1135
Hungary
Trial participating centre
De Hoop ggz
Provincialeweg 70
Dordrecht
3329
Netherlands
Trial participating centre
UPD Bern
Bolligenstrasse 111
3000 Bern 60
3000 Bern 60
Switzerland
Trial participating centre
Novadik-Kentron
Hogedwarsstraat 3
Vught
5261 LX
Netherlands
Trial participating centre
Tactus verslavingszorg
Linie 612
Apeldoorn,
7325 DZ
Netherlands
Sponsor information
Organisation
Beroendecentrum Stockholm
Sponsor details
Friskvårdsvägen 4
plan 2
S:t Göran
Stockholm
11281
Sweden
+46 (0)8 123 400 00
johan.franck@ki.se
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results from the study will be published as soon as possible after the study is completed.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date
Intention to publish date
31/03/2023
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list