Opioid Use DisorderEXPO-R33NCT05688410
Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO; R33 Phase)
A study testing Exercise and Psychotherapy Pain and Addiction (I-STOP) in people with Opioid Use Disorder and Pain, run by Case Western Reserve University at 2 sites in United States.
Trial summary
This work will involve conducting a randomized trial that will evaluate preliminary efficacy of "assisted" rate cycling, voluntary rate cycling and psychotherapy for pain individually and in combination as adjunctive treatments on cravings (primary outcome) in adults with an opioid use disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder, Pain
- What is being tested?
- Exercise and Psychotherapy Pain and Addiction (I-STOP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Feb 2023to 5 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years old
- Must be enrolled in a residential/inpatient drug treatment program at a collaborating drug treatment center
- Must be diagnosed with an Opioid Use Disorder (OUD; ICD-10 F11.20) or a Poly-substance Drug Use that includes an opioid component (ICD-10,F19.xx)
- Must have self-reported pain or a pain condition describing a non-cancer related chronic pain disorder
- Must be approved to exercise in the study by the drug treatment center (Medical Director, physician or other relevant clinical staff or primary care physician (PCP))
Who cannot join
- Any substantive contraindications to exercise
- Psychiatrically unstable
- Pregnant women
- Non-English speaking adults
- Adults unable to provide informed written consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Case Western Reserve University
Cleveland, Ohio, 44106
University of Colorado at Denver
Denver, Colorado, 80217
About this study
Official title: Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO): A Randomized Trial (R33 Phase)
This work will involve conducting a randomized trial that will evaluate preliminary efficacy of "assisted" rate cycling, voluntary rate cycling and psychotherapy for pain individually and in combination as adjunctive treatments on cravings (primary outcome) in adults with an opioid use disorder. The investigators will also evaluate the effects of "assisted" rate cycling, voluntary rate cycling and I-STOP on secondary outcomes including depression, anxiety and sleep.
- Conditions
- Opioid Use Disorder, Pain
- Being tested
- Exercise, Psychotherapy Pain and Addiction (I-STOP)
- Medical subject headings
- Opioid-Related Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Participants who are randomized to exercise will be perform exercise on stationary bikes. Participants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. Participants randomized to "Assisted Exercise" will exercise on a special bike that assists them to pedal faster than they do voluntarily on their own ("assisted (exercise) bike").
Psychotherapy Pain and Addiction (I-STOP)Behavioural
Participants who are randomized to receive I-STOP will receive the "Self-regulation Treatment for Opioid addiction and Pain" (STOP) program modified for inpatients/residential drug treatment (I-STOP). I-STOP uses empirically validated pain psychotherapy approaches targeted to patients with an OUD using psycho-physiological self-regulation components and biofeedback with "Bio-dots".
| Study group | Role | What they receive |
|---|---|---|
| Assisted Exercise and I-STOP | Experimental | Participants randomized to "Assisted Exercise" will exercise on a special bike that assists them to pedal faster than they do voluntarily on their own ("assisted" exercise bike). Participants who are randomized to receive I-STOP will receive the "Self-regulation Treatment for Opioid addiction and Pain" (STOP) program modified for inpatients/residential drug treatment (I-STOP). Receives: Other: Exercise; Behavioral: Psychotherapy Pain and Addiction (I-STOP) |
| Voluntary Exercise and I-STOP | Experimental | Participants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. Participants who are randomized to receive I-STOP will receive the "Self-regulation Treatment for Opioid addiction and Pain" (STOP) program modified for inpatients/residential drug treatment (I-STOP). Receives: Other: Exercise; Behavioral: Psychotherapy Pain and Addiction (I-STOP) |
| Assisted Exercise and No I-STOP | Experimental | Participants randomized to "Assisted Exercise" will exercise on a special bike that assists them to pedal faster than they do voluntarily on their own ("assisted" exercise bike). Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU). Receives: Other: Exercise |
| Voluntary Exercise and No I-STOP | Experimental | Participants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU). Receives: Other: Exercise |
| No Exercise and I-STOP | Experimental | Participants randomized to receive "No Exercise" will not receive structured "assisted" or voluntary rate cycling exercise. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU). Receives: Behavioral: Psychotherapy Pain and Addiction (I-STOP) |
| No Exercise and No I-STOP | No intervention | Participants randomized to receive "No Exercise" will not receive structured "assisted" or voluntary rate cycling exercise. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug cravings
Change in drug cravings: self-report, visual analog scale (VAS), higher scores indicate higher levels of cravings;
Measured: Change from baseline to intervention program completion, an average of 8 weeks
Secondary outcomes (4)
Depression
Change in depression: self-report, standardized questionnaire (Depression sub-scale in Hospital Anxiety and Depression Scale, HADS); Total Score range: 0-21; higher scores indicate higher levels of depression
Measured: Change from baseline to intervention program completion, an average of 8 weeks
Anxiety
Change in anxiety: self-report, standardized questionnaire (Depression sub-scale in Hospital Anxiety and Depression Scale, HADS); Total Score range: 0-21; Higher scores indicate higher levels of anxiety
Measured: Change from baseline to intervention program completion, an average of 8 weeks
Sleep
Change in sleep: self-report, standardized questionnaire (Pittsburgh Sleep Quality Index, PSQI); Total Score range: 0-21; Higher scores indicate poorer sleep quality
Measured: Change from baseline to intervention program completion, an average of 8 weeks
Drug Cravings using Questionnaire
standardized questionnaire (Desires for Drug Questionnaire), higher scores indicate higher levels of cravings
Measured: Change from baseline to intervention program completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start10 Feb 2023
- Primary completion5 Jul 2028 (estimated)
- Study completion5 Jul 2028 (estimated)
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
- Factorial
- Model description
- 2\^1 x 3\^1 factorial randomized clinical trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, National Center for Complementary and Integrative Health (NCCIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Nora Nock, Case Western Reserve University
- Investigators
- Nora L. Nock, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688410
- Sponsor's protocol ID
- STUDY20201427 - R33 Phase
- Other IDs
- 5R33AT010806-03
- Acronym
- EXPO-R33
- Status last verified
- Mar 2026
- First submitted
- 23 Dec 2022
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared as required by NIH HEAL and as deemed acceptable by governing IRB, HIPPA and other regulations.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO): A Randomized Trial (R33 Phase)
- ClinicalTrials.gov ID
- NCT05688410
- Acronym / sponsor ID
- EXPO-R33 / STUDY20201427 - R33 Phase
- Conditions
- Opioid Use Disorder, Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, National Center for Complementary and Integrative Health (NCCIH), National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 5 Jul 2028 (estimated)
- Study completion
- 5 Jul 2028 (estimated)
- First posted
- 18 Jan 2023 (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.
This work will involve conducting a randomized trial that will evaluate preliminary efficacy of "assisted" rate cycling, voluntary rate cycling and psychotherapy for pain individually and in combination as adjunctive treatments on cravings (primary outcome) in adults with an opioid use disorder. The investigators will also evaluate the effects of "assisted" rate cycling, voluntary rate cycling and I-STOP on secondary outcomes including depression, anxiety and sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 6
- Model description
- 2^1 x 3^1 factorial randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Assisted Exercise and I-STOP | Experimental | Other: Exercise, Behavioral: Psychotherapy Pain and Addiction (I-STOP)Participants randomized to "Assisted Exercise" will exercise on a special bike that assists them to pedal faster than they do voluntarily on their own ("assisted" exercise bike). Participants who are randomized to receive I-STOP will receive the "Self-regulation Treatment for Opioid addiction and Pain" (STOP) program modified for inpatients/residential drug treatment (I-STOP). |
| Voluntary Exercise and I-STOP | Experimental | Other: Exercise, Behavioral: Psychotherapy Pain and Addiction (I-STOP)Participants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. Participants who are randomized to receive I-STOP will receive the "Self-regulation Treatment for Opioid addiction and Pain" (STOP) program modified for inpatients/residential drug treatment (I-STOP). |
| Assisted Exercise and No I-STOP | Experimental | Other: ExerciseParticipants randomized to "Assisted Exercise" will exercise on a special bike that assists them to pedal faster than they do voluntarily on their own ("assisted" exercise bike). Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU). |
| Voluntary Exercise and No I-STOP | Experimental | Other: ExerciseParticipants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU). |
| No Exercise and I-STOP | Experimental | Behavioral: Psychotherapy Pain and Addiction (I-STOP)Participants randomized to receive "No Exercise" will not receive structured "assisted" or voluntary rate cycling exercise. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU). |
| No Exercise and No I-STOP | No intervention | –Participants randomized to receive "No Exercise" will not receive structured "assisted" or voluntary rate cycling exercise. Participants randomized to "No I-STOP" will not receive the psychotherapy for pain and addiction but will receive their standard behavioral treatment as usual (TAU). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 65 years old
- Must be enrolled in a residential/inpatient drug treatment program at a collaborating drug treatment center
- Must be diagnosed with an Opioid Use Disorder (OUD; ICD-10 F11.20) or a Poly-substance Drug Use that includes an opioid component (ICD-10,F19.xx)
- Must have self-reported pain or a pain condition describing a non-cancer related chronic pain disorder
- Must be approved to exercise in the study by the drug treatment center (Medical Director, physician or other relevant clinical staff or primary care physician (PCP))
Key exclusion criteria (5 listed)
- Any substantive contraindications to exercise
- Psychiatrically unstable
- Pregnant women
- Non-English speaking adults
- Adults unable to provide informed written consent
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 |
|---|---|---|
| ExerciseParticipants who are randomized to exercise will be perform exercise on stationary bikes. Participants randomized to "Voluntary Exercise" will exercise on a standard stationary bike where they will pedal at their voluntary rates. Participants randomized to "Assisted Exercise" will exercise on a special bike that assists them to pedal faster than they do voluntarily on their own ("assisted (exercise) bike"). | Other | Assisted Exercise and I-STOP, Assisted Exercise and No I-STOP, Voluntary Exercise and I-STOP, Voluntary Exercise and No I-STOP |
| Psychotherapy Pain and Addiction (I-STOP)Participants who are randomized to receive I-STOP will receive the "Self-regulation Treatment for Opioid addiction and Pain" (STOP) program modified for inpatients/residential drug treatment (I-STOP). I-STOP uses empirically validated pain psychotherapy approaches targeted to patients with an OUD using psycho-physiological self-regulation components and biofeedback with "Bio-dots". | Behavioural | Assisted Exercise and I-STOP, No Exercise and I-STOP, Voluntary Exercise and I-STOP |
Primary outcome
Drug cravings
Time frame: Change from baseline to intervention program completion, an average of 8 weeks
Change in drug cravings: self-report, visual analog scale (VAS), higher scores indicate higher levels of cravings;
4 secondary outcomes
Depression
Time frame: Change from baseline to intervention program completion, an average of 8 weeks
Anxiety
Time frame: Change from baseline to intervention program completion, an average of 8 weeks
Sleep
Time frame: Change from baseline to intervention program completion, an average of 8 weeks
Drug Cravings using Questionnaire
Time frame: Change from baseline to intervention program completion, an average of 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Undecided. Data will be shared as required by NIH HEAL and as deemed acceptable by governing IRB, HIPPA and other regulations.
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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.
Nora L. Nock, PhD principal investigator
Case Western Reserve University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Psychotherapy Pain and Addiction (I-STOP) in people with Opioid Use Disorder and Pain, run by Case Western Reserve University at 2 sites in United States.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Drug cravings (time frame: Change from baseline to intervention program completion, an average of 8 weeks). 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 24 Mar 2026.