Clinical trial NCT04496934: Physical Activity as Adjunct Treatment for Opioid Substitution Therapy
Official title: Physical Activity as Adjunct Treatment for Opioid Substitution Therapy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Opioid-use Disorder
Substance Use Disorders
Opioid Dependence
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Helse Stavanger HF
name: Kristiania University College
name: University of Bergen
name: Western Norway University of Applied Sciences
name: Solli Distriktspsykiatriske Senter
First posted: 2020-08-04
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Height and weight
timeFrame: 12 weeks
measure: Endurance
timeFrame: 12 weeks
measure: Strength
timeFrame: 12 weeks
measure: Balance
timeFrame: 12 weeks
Secondary outcomes:
measure: Alcohol use
timeFrame: 12 weeks
measure: Drug use
timeFrame: 12 weeks
measure: Executive functions
timeFrame: 12 weeks
measure: Satisfaction with life
timeFrame: 12 weeks
measure: Sleep quality
timeFrame: 12 weeks
measure: Attention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Kristiania University College
name: Asgeir Mamen, PhD
role: STUDY_DIRECTOR
affiliation: University of Bergen
name: Lars Thore Fadnes, PhD
role: STUDY_DIRECTOR
References: