Physical Activity as Adjunct Treatment for Opioid Substitution Therapy

Substance Use Disorders Clinical Trial

Official title:

Physical Activity as Adjunct Treatment for Opioid Substitution Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496934
• Other study ID #: 2013/00731
• Status: Completed
• Phase: N/A
• Start date: January 30, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: July 2020
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Opioid Dependence
• Opioid-Related Disorders
• Opioid-use Disorder
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (6)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse Stavanger HF, Kristiania University College, Solli Distriktspsykiatriske Senter, University of Bergen, Western Norway University of Applied Sciences

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height and weight	Weight and height will be combined to report BMI in kg/m^2	12 weeks
Primary	Endurance	Ventilatory threshold/VO2max (endurance test on treadmill)	12 weeks
Primary	Strength	Push-ups (maximal test where the participants perform a maximum number of correct push-ups)	12 weeks
Primary	Balance	Stork Balance Test (timed test where the goal is to keep one's balance as long as possible)	12 weeks
Secondary	Alcohol use	AUDIT-E	12 weeks
Secondary	Drug use	DUDIT-E	12 weeks
Secondary	Executive functions	Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)	12 weeks
Secondary	Satisfaction with life	Satisfaction With Life Scale (SWLS); Values/scores: 7 - Strongly agree; 6 - Agree; 5 - Slightly agree; 4 - Neither agree nor disagree; 3 - Slightly disagree; 2 - Disagree; 1 - Strongly disagree; Results (sum of scores/values): 31 - 35 Extremely satisfied 26 - 30 Satisfied 21 - 25 Slightly satisfied 20 Neutral 15 - 19 Slightly dissatisfied 10 - 14 Dissatisfied 5 - 9 Extremely dissatisfied The higher the score the better the outcome.	12 weeks
Secondary	Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	12 weeks
Secondary	Attention	Connors Continuous Performance Test (CPT 3)	12 weeks