Physical Activity as Adjunct Treatment for Opioid Substitution Therapy

NCT04496934 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-04-02

No results posted yet for this study

Summary

In terms of research, it is documented that exercise has a positive effect on mental disorders. Studies have shown positive correlations between physical and mental health, also among substance users. Such a study has never been performed on patients in opioid substitution therapy (OST). Documentation on the physical health of patients and the effect of exercise is very limited. Treatment of substance users is a research area with insufficient knowledge about certain treatment effects. It is important that a treatment can both support and promote the user's own resources and efforts to change their habits of substance use.

The objective of this project is to examine the effect of exercise for OST patients, measured in relation to cognitive function and physical form. The target group consists of OST patients from 18 years of age and up, of both sexes, and on stable medication. At least 60 participants should complete the project, which is designed as a controlled randomized study (RCT). Participants in the intervention group start to exercise immediately after baseline testing. Participants in the control group are on a waiting list and will start to exercise after twelve weeks. Both groups undergo testing at baseline, after three, six and 12 months. Testing consists of two parts: A battery of cognitive and psychosocial assessments and an assessment of physical variables.

The research questions of this project are important in a public health perspective. Generated knowledge can be quickly applied to local treatment institutions in Norway.

Conditions

Interventions

BEHAVIORAL

Exercise

Exercise of choice with a training contact: 3 hrs/week, total of 12 weeks.

Sponsors & Collaborators

  • Helse Stavanger HF

    collaborator OTHER_GOV
  • Kristiania University College

    collaborator OTHER
  • University of Bergen

    collaborator OTHER
  • Western Norway University of Applied Sciences

    collaborator OTHER
  • Solli Distriktspsykiatriske Senter

    collaborator OTHER
  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Asgeir Mamen, PhD · Kristiania University College

  • Lars Thore Fadnes, PhD · University of Bergen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2030-01-31
Completion
2030-12-31

Countries

  • Norway

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04496934 on ClinicalTrials.gov