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NCT Number: NCT05182918

Substance Use and Lifestyle-related Health Problems in Ageing Patients in OMT 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).

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Key information

Conditions

Substance Use Disorders Behavior Chemically-Induced Disorders Health, Subjective Mental Disorders Mental Health Impairment Narcotic-Related Disorders Opioid Use Disorder Opioid-Related Disorders Substance-Related Disorders Tobacco Use

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Addiction Unit - Sørlandet Hospital

Kristiansand, Agder, 4600, Norway

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Substance use disorder treatment

Other

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.

Primary outcomes

  1. Tobacco use

    Time frame: Approximately one year after admission to treatment (range 11 - 18 months)

    Changes in tobacco use from baseline to follow-up

  2. 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.

  3. 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".

Secondary outcomes

  1. Mental distress

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Collaborators

  • University of Oslo

Registry information

Official study title

Substance Use and Lifestyle-related Health Problems Among Ageing Patients in OMT and Other SUD Treatment

Acronym: AgeSUD

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 10, 2022
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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