Physical Activity as Adjunct Treatment for Opioid Substitution Therapy

NCT ID: NCT04496934

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-30
• Study Completion Date: 2030-12-31

Brief 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

Opioid-use Disorder; Substance Use Disorders; Opioid Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Exercise intervention

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

Control

The control group is a waiting list group. The participants will receive exercise intervention after twelve weeks of treatment as usual.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

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

Interventions

Exercise

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Participants must sign a informed consent form
• Must be participating in an opioid substitution program
• Must be on a steady fixed dose of medication
• Must be at least 18 years of age

Exclusion Criteria

• Pregnancy
• Being in opioid substitution program for less than three months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Stavanger HF

OTHER_GOV

Sponsor Role: collaborator

Kristiania University College

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: collaborator

Western Norway University of Applied Sciences

OTHER

Sponsor Role: collaborator

Solli Distriktspsykiatriske Senter

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asgeir Mamen, PhD

Role: STUDY_DIRECTOR

Kristiania University College

Lars Thore Fadnes, PhD

Role: STUDY_DIRECTOR

University of Bergen

Locations

Haukeland University Hospital

Bergen, , Norway

Countries

Norway

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2013/00731

Identifier Type: -

Identifier Source: org_study_id