Condition category
Mental and Behavioural Disorders
Date applied
20/12/2019
Date assigned
06/02/2020
Last edited
06/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.beroendecentrum.se/

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

Publication citations

Additional files

Editorial Notes

02/01/2020: Trial’s existence confirmed by Swedish Ethical Review Authority.