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Can a restless legs drug ease opioid withdrawal?

NCT ID NCT04759703

Symptom relief Sponsor: Massachusetts General Hospital 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether pramipexole (Mirapex), a drug for restless legs syndrome, could also reduce symptoms of opioid withdrawal in people with opioid use disorder. The trial planned to enroll 75 adults but was terminated early. Researchers measured changes in restless legs severity and withdrawal scores after two weeks.

What this could mean

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

Active substance
Pramipexole (Mirapex)
What this could lead to
If it worked, this could point toward a way to reduce restless legs and withdrawal symptoms, helping people stay in treatment for opioid use disorder.
What could go wrong
This was a small pilot study that was terminated early, so results are limited. It is unclear if pramipexole is effective or safe for this use.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

75 people

The number who actually took part.

Started

Jan 2022

Finished

May 2024

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 75 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: 1. Men or women of any ethnic origin. 2. Written informed consent is obtained 3. Speaks and writes in English 4. A willingness and ability to comply with study procedures. 5. Age 18-75 years 6. Patients with diagnosed OUD who have undergone primary detoxification for their OUD in the Gavin Acute Treatment Service (ATS), have been transferred to the Gavin Clinical Stabilization Service (CSS), and have some persistent opioid withdrawal as indicated by a Subjective Opiate Withdrawal Scale (SOWS) \>1 on Day 1 7. Diagnosis of RLS from the Hening Telephone Diagnostic Interview (HTDI) with subsequent confirmation by clinical interview conducted by a study physician 8. International Restless Legs Syndrome Severity Scale (IRLS) Symptoms subscale score of \>15 for three consecutive days prior to randomization Exclusion Criteria: 1. Receiving opioid-agonist medications at transfer to the CSS 2. Pregnant 3. Participants with active or unstable major psychiatric disorder other than OUD, who, in the investigators' judgment, require further treatment 4. Use of dopaminergic agonists or antagonists within the last 30 days 5. Alcohol use disorder within the last 30 days 6. History of being treated for RLS, specifically with dopamine agonist medications 7. Methamphetamine or benzodiazepine dependence in the last 30 days 8. Neurological disorder or cardiovascular disease raising safety concerns about use of pramipexole and/or judged to interfere with ability to assess efficacy of the treatment 9. Medical instability considered to interfere with study procedures 10. Stage 3, 4, or 5 renal insufficiency 11. Participation in this study on a previous admission to the CSS

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Conditions

The condition(s) this trial relates to.

opiate dependence restless legs syndrome sleep disorder sleep-wake disorder substance withdrawal syndrome

As listed by the trial registrant

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

Opioid use disorder Opioid withdrawal Restless legs syndrome Sleep disorder

Contacts and locations

Locations

  • Gavin Foundation Clinical Stabilization Services

    Quincy, Massachusetts, 02170, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

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