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

Substance Use Disorders Clinical Trial

— AgeSUD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05182918
• Other study ID #: 813485
• Status: Completed
• Start date: December 1, 2012
• Est. completion date: August 31, 2016

Study information

• Verified date: December 2021
• Source: Sorlandet Hospital HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 548
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Health, Subjective
• Mental Health Impairment
• Opioid Use Disorder
• Opioid-Related Disorders
• Substance Use Disorders
• Substance-Related Disorders
• Tobacco Use

Intervention

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.

Locations

Country	Name	City	State
Norway	Addiction Unit - Sørlandet Hospital	Kristiansand	Agder

Sponsors (2)

Lead Sponsor	Collaborator
Sorlandet Hospital HF	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tobacco use	Changes in tobacco use from baseline to follow-up	Approximately one year after admission to treatment (range 11 - 18 months)
Primary	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)
Primary	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	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)
Secondary	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)