Opioid-use DisorderNCT04496934
Physical Activity as Adjunct Treatment for Opioid Substitution Therapy
A study testing Exercise in people with Opioid-use Disorder and Substance Use Disorders, run by Haukeland University Hospital at 1 site in Norway.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder, Substance Use Disorders, Opioid Dependence
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNorway
- Study dates
- 30 Jan 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Being in opioid substitution program for less than three months
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Exercise
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise of choice with a training contact: 3 hrs/week, total of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Exercise intervention Receives: Behavioral: Exercise |
| Control | Active comparator | The control group is a waiting list group. The participants will receive exercise intervention after twelve weeks of treatment as usual. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height and weight
Weight and height will be combined to report BMI in kg/m^2
Measured: 12 weeks
Endurance
Ventilatory threshold/VO2max (endurance test on treadmill)
Measured: 12 weeks
Strength
Push-ups (maximal test where the participants perform a maximum number of correct push-ups)
Measured: 12 weeks
Balance
Stork Balance Test (timed test where the goal is to keep one's balance as long as possible)
Measured: 12 weeks
Secondary outcomes (6)
Alcohol use
AUDIT-E
Measured: 12 weeks
Drug use
DUDIT-E
Measured: 12 weeks
Executive functions
Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Measured: 12 weeks
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.
Measured: 12 weeks
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: 12 weeks
Attention
Connors Continuous Performance Test (CPT 3)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start30 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Stavanger HF, Kristiania University College, University of Bergen, Western Norway University of Applied Sciences, Solli Distriktspsykiatriske Senter
- Responsible party
- Sponsor
- Investigators
- Asgeir Mamen, PhD, Study director, Kristiania University CollegeLars Thore Fadnes, PhD, Study director, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496934
- Sponsor's protocol ID
- 2013/00731
- Status last verified
- Sep 2026
- First submitted
- 25 Oct 2018
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity as Adjunct Treatment for Opioid Substitution Therapy
- ClinicalTrials.gov ID
- NCT04496934
- Acronym / sponsor ID
- 2013/00731
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Helse Stavanger HF, Kristiania University College, University of Bergen, Western Norway University of Applied Sciences, Solli Distriktspsykiatriske Senter
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ExerciseExercise intervention |
| Control | Active comparator | Behavioral: ExerciseThe control group is a waiting list group. The participants will receive exercise intervention after twelve weeks of treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- Being in opioid substitution program for less than three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise of choice with a training contact: 3 hrs/week, total of 12 weeks. | Behavioural | Control, Intervention |
Primary outcome
Height and weight
Time frame: 12 weeks
Weight and height will be combined to report BMI in kg/m^2
Endurance
Time frame: 12 weeks
Ventilatory threshold/VO2max (endurance test on treadmill)
Strength
Time frame: 12 weeks
Push-ups (maximal test where the participants perform a maximum number of correct push-ups)
Balance
Time frame: 12 weeks
Stork Balance Test (timed test where the goal is to keep one's balance as long as possible)
6 secondary outcomes
Alcohol use
Time frame: 12 weeks
Drug use
Time frame: 12 weeks
Executive functions
Time frame: 12 weeks
Satisfaction with life
Time frame: 12 weeks
Sleep quality
Time frame: 12 weeks
Attention
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asgeir Mamen, PhD study director
Kristiania University College
Lars Thore Fadnes, PhD study director
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Opioid-use Disorder and Substance Use Disorders, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height and weight (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.