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

Sponsor
Sorlandet Hospital HF (Other)
Overall Status
Completed
CT.gov ID
NCT05182918
Collaborator
University of Oslo (Other)
548
1
45
12.2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • 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 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 present PhD-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

Study Type:
Observational
Actual Enrollment :
548 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Substance Use and Lifestyle-related Health Problems Among Ageing Patients in OMT and Other SUD Treatment
Actual Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Aug 31, 2016
Actual Study Completion Date :
Aug 31, 2016

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Tobacco use [Approximately one year after admission to treatment (range 11 - 18 months)]

    Changes in tobacco use from baseline to follow-up

  2. Substance use [Approximately one year after admission to treatment (range 11 - 18 months)]

    Changes in substance use from baseline to follow-up. Excerpts from the EuropASI were used to collect data on substance use and a severity score was calculated according to EuropASI instructions, ranging from 0 to 1, where 1 is the highest severity.

Secondary Outcome Measures

  1. Mental distress [Approximately one year after admission to treatment (range 11 - 18 months)]

    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).

  2. QoL (quality of life) [Approximately one year after admission to treatment (range 11 - 18 months)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Addiction Unit - Sørlandet Hospital Kristiansand Agder Norway 4600

Sponsors and Collaborators

  • Sorlandet Hospital HF
  • University of Oslo

Investigators

  • Principal Investigator: Thomas Clausen, PhD, Norwegian Centre for Addiction Research, University of Oslo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT05182918
Other Study ID Numbers:
  • 813485
First Posted:
Jan 10, 2022
Last Update Posted:
Jan 10, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2022