Substance Use DisordersAgeSUDNCT05182918
Substance Use and Lifestyle-related Health Problems in Ageing Patients in OMT Treatment
An observational study of Substance Use Disorders and Opioid Use Disorder, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
The overall aim of the study is to explore substance use, tobacco use and lifestyle-related health problems among ageing patients in Opioid Maintenance Treatment (OMT), and other SUD treatment. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Substance Use Disorders, Opioid Use Disorder, Tobacco Use
- What is being tested?
- Substance use disorder treatment
- How many people
- 548 participants
- Where
- 1 siteNorway
- Study dates
- 1 Dec 2012to 31 Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were included in the study from 21 participating treatment facilities across Norway, 14 were opioid maintenance treatment (OMT) outpatient centers, and 7 were inpatient centers (predominately non-OMT). Apart from an established opioid use disorder diagnosis there are no further criteria for entering OMT treatment, although generally substitution free treatment is recommended as a first option. In-patient SUD treatment represented in the present project typically has a duration of 6-9 months, primarily with non-OMT treatment in therapeutic community-like settings. Some patients would transfer to an outpatient treatment after completing in-patient treatment.
Who may be able to join
- Admittance to a substance use disorder treatment facility, either standardized opioid maintenance treatment (OMT) or other substance use disorder treatment (in-patient)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Substance Use and Lifestyle-related Health Problems Among Ageing Patients in OMT and Other SUD Treatment
The overall aim of the study is to explore substance use, tobacco use and lifestyle-related health problems among ageing patients in Opioid Maintenance Treatment (OMT), and other SUD treatment.
The study will use already collected data from the multi-center, longitudinal, observational NorComt study (Norwegian Cohort of Patients in Opioid Maintenance Treatment and Other Drug Treatment study).
NorComt is the largest longitudinal study of SUD patients in Norway. The data consists of data from OMT and other substance use disorders (SUD) treatment (N=548).
Read the detailed description
The overall aim of the study is to explore substance use, tobacco use and lifestyle-related health problems among ageing patients in Opioid Maintenance Treatment (OMT), and other SUD treatment.
The study will use already collected data from the multi-center, longitudinal, observational NorComt (Norwegian Cohort of Patients in Opioid Maintenance Treatment and Other Drug Treatment) study.
NorComt is the largest longitudinal study of SUD patients in Norway. The data consists of data from OMT and other substance use disorders (SUD) treatment (N=548).
The present doctoral research degree project is financed by the Southern and Eastern Norway Regional Health Authority, and hosted by Sørlandet hospital in collaboration with the Norwegian Centre for Addiction Research (SERAF).
Ethical approval for analysis of NorComt data and for the planned registry data linkages of NorComt data has been granted by the Norwegian Regional Ethics Committee (REK 2012/1131).
- Conditions
- Substance Use Disorders, Opioid Use Disorder, Tobacco Use, Health, Subjective, Mental Health Impairment
- Being tested
- Substance use disorder treatment
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Substance use disorder treatmentOther
The study followed a heterogenous sample of patients in opioid maintenance treatment (OMT) and other substance use disorder treatment. The main focus was on health related problems in this cohort, with focus on tobacco use and substance use.
| Study group | Role | What they receive |
|---|---|---|
| Patients in OMT and other SUD treatment | Patients in opioid maintenance treatment and other substance use disorder treatment Receives: Other: Substance use disorder treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco use
Changes in tobacco use from baseline to follow-up
Measured: Approximately one year after admission to treatment (range 11 - 18 months)
Substance use
Changes in substance use from baseline to follow-up. Excerpts from the European version were used to collect data on substance use. Substance use was scored for the previous 4 weeks on a 6-point response format were 0 corresponded to "No use" and 5 corresponded to "Daily use". 1 year follow-up were compared with baseline values.
Measured: Approximately one year after admission to treatment (range 11 - 18 months)
Somatic complaints.
Changes in somatic complaints from baseline to follow-up. A checklist containing 16 somatic complaints common among chronic drug users, including major organ systems. Responses are provided on a 0 -4 response format, with 0 corresponding to "not at all", 1 "a little", 2 "moderately", 3 "a lot", and 4 "very much".
Measured: Approximately one year after admission to treatment (range 11 - 18 months).
Secondary outcomes (2)
Mental distress
Changes from baseline to post-treatment and follow-up. The Hopkins Symptom Checklist (HSCL) 25-item version was used to measure mental distress. Each of the 25 items was scored on a 5-point scale (0-4). An average score was computed, indicating a global severity index of mental distress (GSI).
Measured: Approximately one year after admission to treatment (range 11 - 18 months)
QoL (quality of life)
Excerpts from the QoL10 will be used to assess QoL. The scale has 10 ordinal items and each item is scored from 1 = very poor up to 5 = very good. The scale is transformed to a decimal scale ranging from 0.1 to 0.9 and averaged, where 0.9 is the best QoL. A normative score in a population sample was 0.7.
Measured: Approximately one year after admission to treatment (range 11 - 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start1 Dec 2012
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 548 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
- Investigators
- Thomas Clausen, PhD, Principal investigator, Norwegian Centre for Addiction Research, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182918
- Sponsor's protocol ID
- 813485
- Acronym
- AgeSUD
- Status last verified
- Dec 2021
- First submitted
- 22 Dec 2021
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized data can be shared upon reasonable request
Publications
Bjornestad ED, Vederhus JK, Clausen T. Change in substance use among patients in opioid maintenance treatment: baseline to 1-year follow-up. Harm Reduct J. 2024 May 24;21(1):101. doi: 10.1186/s12954-024-01005-x.
PubMed 38790008Bjornestad ED, Vederhus JK, Clausen T. Change in self-reported somatic symptoms among patients in opioid maintenance treatment from baseline to 1-year follow-up. BMC Psychiatry. 2024 Feb 21;24(1):149. doi: 10.1186/s12888-024-05590-w.
PubMed 38383345
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Use and Lifestyle-related Health Problems Among Ageing Patients in OMT and Other SUD Treatment
- ClinicalTrials.gov ID
- NCT05182918
- Acronym / sponsor ID
- AgeSUD / 813485
- Conditions
- Substance Use Disorders, Opioid Use Disorder, Tobacco Use, Health, Subjective, Mental Health Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 548 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- University of Oslo
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of the study is to explore substance use, tobacco use and lifestyle-related health problems among ageing patients in Opioid Maintenance Treatment (OMT), and other SUD treatment.
The study will use already collected data from the multi-center, longitudinal, observational NorComt study (Norwegian Cohort of Patients in Opioid Maintenance Treatment and Other Drug Treatment study).
NorComt is the largest longitudinal study of SUD patients in Norway. The data consists of data from OMT and other substance use disorders (SUD) treatment (N=548).
Detailed description
The overall aim of the study is to explore substance use, tobacco use and lifestyle-related health problems among ageing patients in Opioid Maintenance Treatment (OMT), and other SUD treatment.
The study will use already collected data from the multi-center, longitudinal, observational NorComt (Norwegian Cohort of Patients in Opioid Maintenance Treatment and Other Drug Treatment) study.
NorComt is the largest longitudinal study of SUD patients in Norway. The data consists of data from OMT and other substance use disorders (SUD) treatment (N=548).
The present doctoral research degree project is financed by the Southern and Eastern Norway Regional Health Authority, and hosted by Sørlandet hospital in collaboration with the Norwegian Centre for Addiction Research (SERAF).
Ethical approval for analysis of NorComt data and for the planned registry data linkages of NorComt data has been granted by the Norwegian Regional Ethics Committee (REK 2012/1131).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in OMT and other SUD treatment | – | Other: Substance use disorder treatmentPatients in opioid maintenance treatment and other substance use disorder treatment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were included in the study from 21 participating treatment facilities across Norway, 14 were opioid maintenance treatment (OMT) outpatient centers, and 7 were inpatient centers (predominately non-OMT). Apart from an established opioid use disorder diagnosis there are no further criteria for entering OMT treatment, although generally substitution free treatment is recommended as a first option. In-patient SUD treatment represented in the present project typically has a duration of 6-9 months, primarily with non-OMT treatment in therapeutic community-like settings. Some patients would transfer to an outpatient treatment after completing in-patient treatment.
Key inclusion criteria (1 listed)
- Admittance to a substance use disorder treatment facility, either standardized opioid maintenance treatment (OMT) or other substance use disorder treatment (in-patient)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Substance use disorder treatmentThe study followed a heterogenous sample of patients in opioid maintenance treatment (OMT) and other substance use disorder treatment. The main focus was on health related problems in this cohort, with focus on tobacco use and substance use. | Other | Patients in OMT and other SUD treatment |
Primary outcome
Tobacco use
Time frame: Approximately one year after admission to treatment (range 11 - 18 months)
Changes in tobacco use from baseline to follow-up
Substance use
Time frame: Approximately one year after admission to treatment (range 11 - 18 months)
Changes in substance use from baseline to follow-up. Excerpts from the European version were used to collect data on substance use. Substance use was scored for the previous 4 weeks on a 6-point response format were 0 corresponded to "No use" and 5 corresponded to "Daily use". 1 year follow-up were compared with baseline values.
Somatic complaints.
Time frame: Approximately one year after admission to treatment (range 11 - 18 months).
Changes in somatic complaints from baseline to follow-up. A checklist containing 16 somatic complaints common among chronic drug users, including major organ systems. Responses are provided on a 0 -4 response format, with 0 corresponding to "not at all", 1 "a little", 2 "moderately", 3 "a lot", and 4 "very much".
2 secondary outcomes
Mental distress
Time frame: Approximately one year after admission to treatment (range 11 - 18 months)
QoL (quality of life)
Time frame: Approximately one year after admission to treatment (range 11 - 18 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Derived from this study: PubMed 38790008Bjornestad ED, Vederhus JK, Clausen T. Change in substance use among patients in opioid maintenance treatment: baseline to 1-year follow-up. Harm Reduct J. 2024 May 24;21(1):101. doi: 10.1186/s12954-024-01005-x.
- Derived from this study: PubMed 38383345Bjornestad ED, Vederhus JK, Clausen T. Change in self-reported somatic symptoms among patients in opioid maintenance treatment from baseline to 1-year follow-up. BMC Psychiatry. 2024 Feb 21;24(1):149. doi: 10.1186/s12888-024-05590-w.
- Individual participant dataSharing planned: Undecided. Anonymized data can be shared upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Clausen, PhD principal investigator
Norwegian Centre for Addiction Research, University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders and Opioid Use Disorder, run by Sorlandet Hospital HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco use (time frame: Approximately one year after admission to treatment (range 11 - 18 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05182918, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.