How can we improve opioid assisted medical treatment for people with externalizing behavior?

ISRCTN ISRCTN19554367
DOI https://doi.org/10.1186/ISRCTN19554367
Submission date
03/07/2020
Registration date
04/09/2020
Last edited
24/08/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Birgitte Thylstrup
Scientific

Egilsgade, 5. 4th floor
Copenhagen
2300
Denmark

ORCiD logoORCID ID 0000-0001-5658-5392
Phone +45 2158 7881
Email bt.crf@psy.au.dk
Dr Morten Hesse
Scientific

Brigadevej 34
Copenhagen
2300
Denmark

ORCiD logoORCID ID 0000-0002-6849-6554
Phone +45 2166 4936
Email mh.crf@psy.au.dk
Prof Mads Uffe Pedersen
Scientific

Toftesvinget 11
Egå
8250
Denmark

ORCiD logoORCID ID 0000-0003-1964-1062
Phone +45 6020 2711
Email mup.crf@psy.au.dk

Study information

Study designClinical multicentre randomized controlled trial with longitudinal case-controls
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Community
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleMulticentre RCT comparing two interventions targeting externalizing behavior in patients enrolled in opioid agonist treatment (OAT)
Study acronymILC
Study objectivesIntervention 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
Health condition(s) or problem(s) studiedExternalising behavior
InterventionA 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 typeBehavioural
Primary outcome measure1. Dropout from treatment as defined by being discharged for any reason other than having completed the treatment program
Secondary outcome measures1. 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 date01/02/2020
Completion date01/09/2024

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants137
Key inclusion criteria1. Enrolment in opioid assisted treatment
2. Externalizing behavior assessed with EP6 (AdultMap)
3. Ability to engage in individual treatment sessions
Key exclusion criteria1. Current psychosis
2. Severe aggressive and chaotic behavior
Date of first enrolment01/10/2020
Date of final enrolment24/08/2023

Locations

Countries of recruitment

  • Denmark

Study participating centres

Aarhus Municipality Center for Substance abuse treatment
Sumatravej 3
Aarhus
8000
Denmark
Randers Municipality Center for Substance abuse treatment
Gammel Hadsundvej 1
Randers
8900
Denmark
Aabenraa Municipality Center for Substance abuse treatment
Reberbanen 3
Aabenraa
6200
Denmark
Herning Municipality Center for Substance abuse treatment
Tietgensgade 5
Herning
7400
Denmark
Køge Municipality Center for Substance abuse treatment
Boholtevej 85
Køge
4600
Denmark

Sponsor information

TrygFonden
Industry

Hummeltoftevej 49
Virum
2830
Denmark

Phone +45 4526 0800
Email info@trygfonden.dk
Website https://www.tryghed.dk/
ROR logo "ROR" https://ror.org/02rcazp29

Funders

Funder type

Industry

TrygFonden
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Tryg Foundation
Location
Denmark

Results and Publications

Intention to publish date06/01/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in high-impact peer-reviewed journals.
Planned national report.
IPD sharing planRaw 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article 07/04/2021 09/04/2021 Yes No

Editorial Notes

24/08/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/10/2021 to 24/08/2023.
2. The overall trial end date has been changed from 01/09/2023 to 01/09/2024 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 06/01/2023 to 06/01/2024.
4. The trial participating centre “Køge Municipality Center for Substance abuse treatment” has been added.
05/11/2021: The following changes have been made:
1. The overall trial end date has been changed from 01/09/2022 to 01/09/2023 and the plain English summary has been updated accordingly.
2. The intention to publish date has been changed from 06/01/2022 to 06/01/2023.
09/04/2021: Publication reference added.
06/07/2020: Trial’s existence confirmed by National Comittee on Health Research Ethics, Region MidtJyllan.