Physical Activity as Adjunct Treatment for Opioid Substitution Therapy

Haukeland University Hospital

Status: Suspended

Conditions: Opioid-use Disorder; Substance Use Disorders; Opioid Dependence

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04496934

2013/00731

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Intervention

Experimental group

Description:

Exercise intervention

Treatment:

Behavioral: Exercise

Control

Active Comparator group

Description:

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

Treatment:

Behavioral: Exercise