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Can cycling and counseling curb opioid cravings?

NCT ID NCT05688410

Symptom relief Sponsor: Case Western Reserve University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether stationary cycling (at a voluntary or assisted pace) and a type of psychotherapy called I-STOP can reduce drug cravings in adults with opioid use disorder and chronic pain. About 198 people in residential treatment will try these approaches alone or together. Researchers will also check if these treatments improve depression, anxiety, and sleep.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
exercise (stationary cycling) and psychotherapy (I-STOP)
What this could lead to
If it works, this could point toward a non-drug way to help people in treatment for opioid addiction manage cravings and pain.
What could go wrong
This is an early-stage trial with only 198 participants, so results may not apply to everyone. The effects may be small or not last long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 198 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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)) Exclusion Criteria: * Any substantive contraindications to exercise * Psychiatrically unstable * Pregnant women * Non-English speaking adults * Adults unable to provide informed written consent

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Conditions

The condition(s) this trial relates to.

chronic pain syndrome opiate dependence Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid-use disorder Pain

Contacts and locations

Locations

  • Case Western Reserve University

    Cleveland, Ohio, 44106, United States

  • University of Colorado at Denver

    Denver, Colorado, 80217, United States

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