Plain English Summary
Background and study aims
Opioid use disorder (OUD) is a medical condition with substantial and increasing contribution to the global disease burden. Opioid assisted treatment (OAT) is treatment involving a substitute drug, such as methadone, which allows patients to get on with treatment without having to worry about withdrawing or buying street drugs. However, although treatment for alcohol and drug disorders is free of charge in Denmark, there is an alarming number of people who are hard to reach and retain in OAT, and who often experience low quality of life, continue substance use, and who display criminal behavior and have increased mortality.
This trial evaluates the feasibility, acceptability, clinical, and cost-effectiveness of a combination of the Impulsive Lifestyle Counseling program (ILC) and MOVE-individual versus MOVE individual in OAT in four community-based public treatment centers in Denmark. The primary aim is to test whether an intervention with a combination of ILC and MOVE-individual (i) will improve retention more than MOVE (i) for service users with externalizing behavior enrolled in OAT. A secondary aim is, through registers, to investigate whether ILC and MOVE (i) are superior to treatment as usual in municipalities, where ILC and MOVE have not been implemented in OAT.
Who can participate?
Adult patients (over 18) who are seeking/are enrolled in OAT are eligible for participation in the study. Patients with ongoing delusions or psychosis, severe threatening or aggressive behavior and/or severe cognitive impairment will be excluded from the trial.
What does the study involve?
The trial will take place in four different public municipality treatment centers, and 137 individuals who will seek/are undergoing OAT in these four centers will be offered participation in the study. At each treatment center, participants will be randomized to two conditions (ILC and MOVE (i). Both arms consist of primary treatment (14 sessions). All participants will receive vouchers at every second treatment attendance and at follow-up interviews.
What are the possible benefits and risks of study participation?
Receiving treatment through two interventions (ILC and MOVE (i) that have been tested in RCTs with promising results and positive evaluations from the participating patients; receiving vouchers worth 200 DKK at every other session attendance throughout the trial; receiving vouchers for participating in the follow-up interviews; supporting the development of OAT in Denmark. There are no known risks of participating in the study.
Where is the study conducted?
Recruitment and treatment will be managed by the four participating treatment centers. Data management and analyses will be carried out by The Center for Alcohol and Drug Research, Aarhus University. Data will be stored in secured servers.
When is the study starting and how long is it expected to run?
Patient intake will begin early October 2020 and will continue for one year. Data management, analyses and development of reports/papers will continue until 1/09/2024.
Who is funding the study?
Trygfonden (Denmark)
Who is the main contact?
Birgitte Thylstrup, Associate professor, bt.crf@psy.au.dk, Centre for Drug and Alcohol Research, Aarhus University
Morten Hesse, Associate professor, mh.crf@psy.au.dk, Centre for Drug and Alcohol Research, Aarhus University
Mads Uffe Pedersen, mup.crf@psy.au.dk, Professor, Centre for Drug and Alcohol Research, Aarhus University
Study website
Contact information
Type
Scientific
Contact name
Dr Birgitte Thylstrup
ORCID ID
http://orcid.org/0000-0001-5658-5392
Contact details
Egilsgade
5. 4th floor
Copenhagen
2300
Denmark
+45 2158 7881
bt.crf@psy.au.dk
Type
Scientific
Contact name
Dr Morten Hesse
ORCID ID
http://orcid.org/0000-0002-6849-6554
Contact details
Brigadevej 34
Copenhagen
2300
Denmark
+45 2166 4936
mh.crf@psy.au.dk
Type
Scientific
Contact name
Prof Mads Uffe Pedersen
ORCID ID
http://orcid.org/0000-0003-1964-1062
Contact details
Toftesvinget 11
Egå
8250
Denmark
+45 6020 2711
mup.crf@psy.au.dk
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Multicentre RCT comparing two interventions targeting externalizing behavior in patients enrolled in opioid agonist treatment (OAT)
Acronym
ILC
Study hypothesis
Intervention with a combination of Impulsive Lifestyle Counseling and MOVE-individual (i)(combination of Motivational Interviewing (MI) and Cognitive behavioral therapy (CBT)) will improve retention more than MOVE (i) for service users with externalizing behavior enrolled in opioid agonist treatment. The primary objective is to investigate whether ILC is superior to MOVE (i). A secondary objective is, through registers, to investigate if ILC and MOVE (i) are superior to treatment as usual in municipalities, where ILC and MOVE have not been implemented in OAT.
Ethics approval(s)
Approved 06/06/2020, National Comittee on Health Research Ethics, Region MidtJyllan (Regionssekretariatet - Region Midtjylland, Skottenborg 26, 8800 Viborg, Denmark; +45 7841 0183; komite@rm.dk; ph), ref: 1-10-72-68-20
Study design
Clinical multicentre randomized controlled trial with longitudinal case-controls
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Community
Study type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Externalising behavior
Intervention
A parallel group, two arm, superiority trial comparing ILC with MOVE individual treatment for opioid use disorder (OUD).
Participants will be recruited at four Danish treatment centers in four large Danish cities and municipalities, where the treatment will take place. In all, 137 individuals who seek/are undergoing treatment for opioid use disorders will be offered participation in the study. At each treatment center, participants will be randomized to one of two conditions: ILC/MOVE or MOVE. Recruitment will continue for one year. An extensive baseline assessment will be made approximately one week after randomization (interview by clinician), and follow-up assessments will be conducted at 3 and 9 months post-randomization.
The most important outcome measures are: retention; substance use; every day functioning; illegal activities, social interaction with individuals (family, friends, acquaintances) with non-criminal behavior and/or with no substance abuse; employment/educational activities.
The two interventions that are tested in the trial:
1. The Impulsive Lifestyle program (ILC): Eight sessions targeting externalizing and criminal behavior. The ILC aims to support change in lifestyle, and involves a psychoeducational and motivational approach. The eight sessions will be followed by six MOVE (i) sessions.
2. MOVE: 14 MOVE sessions (a combination of motivational interviewing, cognitive behavioral therapy, and contingency management).
All participants will receive vouchers (200 DKK) at every second session attended, and at participation in follow-up interviews.
Case control: The case-control group will be drawn from The Registry of Drug Abusers Undergoing Treatment (SIB). The trial conditions will be compared using SIB; the Danish National Patient Register (Landspatienregistret); The Danish Registry for Causes of Death (Dødsårsagsregistret); The Psychiatric Central Research Register (Det Psykiatriske Centralregister); The Danish Central Crime Register (Det Centrale Kriminalregister) etc.
Randomization procedure: Participants will be asked to answer a short screening instrument identifying sex, age and severity of substance use, psychiatric diagnoses, and income. These questions will be used for randomization. We know from other projects that these questions together constitute a very solid outcome predictor (even 21 months after enrollment to treatment). Randomization will be performed by means of the minimization method using Minim randomization software, which is a biased-coin approach with a probability of 0.7 to 0.8 for allocation of the “best fitting” treatment (Bally et al., 2018). The minimization method is chosen to obtain an overall balanced distribution of participants, as the number of participants would most likely be too small for true randomization.
Follow-up: 3 and 9 months post-randomization
Intervention type
Behavioural
Primary outcome measure
1. Dropout from treatment as defined by being discharged for any reason other than having completed the treatment program
Secondary outcome measures
1. Use of substances other than prescribed medications. Substance use is measured in all attended sessions using TEM screening (Trivsels og Effekt Monitorering). TEM consists of 17 items of which eight are related to substance use and will be used to monitor potential substance use in the last seven days before each counseling session. Further, participants will be asked about substance use within the last month (AdultMap)
2. Everyday functioning (concentration, planning, keeping appointments, sleep, eating habits, cleaning etc.) last month (AdultMap) and last week (TEM screening in counselling session)
3. Illegal activities last month (AdultMap)
4. Social interaction with individuals (family, friends, acquaintances) with non-criminal behavior and/or with no substance abuse (AdultMap) in last month
5. Employment/educational activities (AdultMap) in last month
Overall study start date
01/02/2020
Overall study end date
01/09/2024
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Enrolment in opioid assisted treatment
2. Externalizing behavior assessed with EP6 (AdultMap)
3. Ability to engage in individual treatment sessions
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
137
Participant exclusion criteria
1. Current psychosis
2. Severe aggressive and chaotic behavior
Recruitment start date
01/10/2020
Recruitment end date
24/08/2023
Locations
Countries of recruitment
Denmark
Study participating centre
Aarhus Municipality Center for Substance abuse treatment
Sumatravej 3
Aarhus
8000
Denmark
Study participating centre
Randers Municipality Center for Substance abuse treatment
Gammel Hadsundvej 1
Randers
8900
Denmark
Study participating centre
Aabenraa Municipality Center for Substance abuse treatment
Reberbanen 3
Aabenraa
6200
Denmark
Study participating centre
Herning Municipality Center for Substance abuse treatment
Tietgensgade 5
Herning
7400
Denmark
Study participating centre
Køge Municipality Center for Substance abuse treatment
Boholtevej 85
Køge
4600
Denmark
Sponsor information
Organisation
TrygFonden
Sponsor details
Hummeltoftevej 49
Virum
2830
Denmark
+45 4526 0800
info@trygfonden.dk
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
TrygFonden
Alternative name(s)
Tryg Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Denmark
Results and Publications
Publication and dissemination plan
Planned publication in high-impact peer-reviewed journals.
Planned national report.
Intention to publish date
06/01/2024
Individual participant data (IPD) sharing plan
Raw data will be shared at a later stage on request. In the ILC trial we adhere to the Danish data protection law and regulations and the study has been approved by the Danish data protection agency. Researchers performing data management, analysis and interpretation will, however, be kept blind to participants’ randomization status at all times during the trial. All enrolled patients eligble for participating in the project will be thoroughly informed about what the project implies and will asked to sign an informed consent. We keep the data we obtain confidential. The researchers in the study may not pass information about individuals in the study, to people who are not a part of the study. Data will consist of data obtained via screening measures and taped conversations (only audio).
All obtained data will be placed on a safe server at Aarhus University. Data will be encrypted and a two factor password will be used to get access. It is only researchers involved in the study who will get access to the data. As soon as all data have been collected they are sent to Statistics Denmark and will be pseudomized. Only Statististic Denmark possess the unique key that can identify specific individuals
The datasets generated during and/or analysed during the current study are/will be available for publication reviewers upon request from Mads Uffe Pedersen: mup@psy.au.dk. Data can be requested after they have been sent to Statistics Denmark and have been pseudomized (in 2021).
After pseudomization data will be used for analyses in reports/papers.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 07/04/2021 | 09/04/2021 | Yes | No |