An observational study in Substance Use Disorders, Opioid Use Disorder and Tobacco Use, sponsored by Sorlandet Hospital HF. Completed at 1 site in Norway. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-06-08.
Sponsored by Sorlandet Hospital HF · Observational
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).
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).
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 548 is above the median of 250 across 296 observational studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Sorlandet Hospital HF is the lead sponsor of 73 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients in opioid maintenance treatment and other substance use disorder treatment
Other: Substance use disorder treatment
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.
Tobacco use
Changes in tobacco use from baseline to follow-up
Time frame: 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.
Time frame: 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".
Time frame: Approximately one year after admission to treatment (range 11 - 18 months).
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).
Time frame: 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.
Time frame: Approximately one year after admission to treatment (range 11 - 18 months)
Plan to share: Undecided — Anonymized data can be shared upon reasonable request
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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Sorlandet Hospital HF