Clinical trial NCT05182918: Substance Use and Lifestyle-related Health Problems in Ageing Patients in OMT Treatment
Official title: Substance Use and Lifestyle-related Health Problems Among Ageing Patients in OMT and Other SUD Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substance Use Disorders
Opioid Use Disorder
Tobacco Use
Health, Subjective
Mental Health Impairment
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: University of Oslo
First posted: 2022-01-10
Enrollment: 548
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* Admittance to a substance use disorder treatment facility, either standardized opioid maintenance treatment (OMT) or other substance use disorder treatment (in-patient)

Exclusion Criteria:

* None

Primary outcomes:
measure: Tobacco use
timeFrame: Approximately one year after admission to treatment (range 11 - 18 months)
measure: Substance use
timeFrame: Approximately one year after admission to treatment (range 11 - 18 months)
measure: Somatic complaints.
timeFrame: Approximately one year after admission to treatment (range 11 - 18 months).
Secondary outcomes:
measure: Mental distress
timeFrame: Approximately one year after admission to treatment (range 11 - 18 months)
measure: QoL (quality of life)
timeFrame: Approximately one year after admission to treatment (range 11 - 18 months)
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Addiction Unit - Sørlandet Hospital
state: Agder
Study officials:
affiliation: Norwegian Centre for Addiction Research, University of Oslo
name: Thomas Clausen, PhD
role: PRINCIPAL_INVESTIGATOR
References: