NCT05182918

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
548

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2016

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
Last Updated

June 8, 2023

Status Verified

December 1, 2021

Enrollment Period

3.8 years

First QC Date

December 22, 2021

Last Update Submit

June 6, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Mental distress

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

  • QoL (quality of life)

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

Study Arms (1)

Patients in OMT and other SUD treatment

Patients in opioid maintenance treatment and other substance use disorder treatment

Other: Substance use disorder treatment

Interventions

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.

Patients in OMT and other SUD treatment

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Admittance to a substance use disorder treatment facility, either standardized opioid maintenance treatment (OMT) or other substance use disorder treatment (in-patient)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addiction Unit - Sørlandet Hospital

Kristiansand, Agder, 4600, Norway

Location

Related Publications (2)

  • Bjornestad ED, Vederhus JK, Clausen T. Change in substance use among patients in opioid maintenance treatment: baseline to 1-year follow-up. Harm Reduct J. 2024 May 24;21(1):101. doi: 10.1186/s12954-024-01005-x.

  • Bjornestad ED, Vederhus JK, Clausen T. Change in self-reported somatic symptoms among patients in opioid maintenance treatment from baseline to 1-year follow-up. BMC Psychiatry. 2024 Feb 21;24(1):149. doi: 10.1186/s12888-024-05590-w.

MeSH Terms

Conditions

Substance-Related DisordersOpioid-Related DisordersTobacco Use

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNarcotic-Related DisordersBehavior

Study Officials

  • Thomas Clausen, PhD

    Norwegian Centre for Addiction Research, University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 10, 2022

Study Start

December 1, 2012

Primary Completion

August 31, 2016

Study Completion

August 31, 2016

Last Updated

June 8, 2023

Record last verified: 2021-12

Locations