Substance Use and Lifestyle-related Health Problems in Ageing Patients in OMT Treatment (AgeSUD)

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).

Study Overview

• Status: Completed
• Conditions: Health, Subjective; Tobacco Use; Opioid Use Disorder; Substance Use Disorders; Mental Health Impairment
• Intervention / Treatment: Other: Substance use disorder treatment

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 Type: Observational
• Enrollment (Actual): 548

Contacts and Locations

Study Locations

• Norway
  • Agder
    • Kristiansand, Agder, Norway, 4600
      • Addiction Unit - Sørlandet Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients in OMT and other SUD treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco use	Changes in tobacco use from baseline to follow-up	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.	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".	Approximately one year after admission to treatment (range 11 - 18 months).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Approximately one year after admission to treatment (range 11 - 18 months)

Collaborators and Investigators

• Sponsor: Sorlandet Hospital HF
• Collaborators: University of Oslo
• Investigators: Principal Investigator: Thomas Clausen, PhD, Norwegian Centre for Addiction Research, University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): August 31, 2016

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Narcotic-Related Disorders; Substance-Related Disorders; Disease; Opioid-Related Disorders
• Other Study ID Numbers: 813485

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Anonymized data can be shared upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No