Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD

Last updated: May 6, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Terminated

Phase

2/3

Condition

Dyskinesias

Opioid Use Disorder

Williams Syndrome

Treatment

Pramipexole

Placebo

Clinical Study ID

NCT04759703
2020P002928
  • Ages 18-75
  • All Genders

Study Summary

The investigators propose to test the use of pramipexole in patients being treated for Opioid Use Disorder to test its ability to reduce symptoms of both Restless Legs Syndrome and protracted opioid withdrawal and thereby promote initiation, engagement, and retention in treatment.

Eligibility Criteria

Inclusion

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 OUDin the Gavin Acute Treatment Service (ATS), have been transferred to the GavinClinical Stabilization Service (CSS), and have some persistent opioid withdrawal asindicated by a Subjective Opiate Withdrawal Scale (SOWS) >1 on Day 1

  7. Diagnosis of RLS from the Hening Telephone Diagnostic Interview (HTDI) withsubsequent confirmation by clinical interview conducted by a study physician

  8. International Restless Legs Syndrome Severity Scale (IRLS) Symptoms subscale scoreof >15 for three consecutive days prior to randomization

Exclusion

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 ofpramipexole and/or judged to interfere with ability to assess efficacy of thetreatment

  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

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Pramipexole
Phase: 2/3
Study Start date:
January 24, 2022
Estimated Completion Date:
May 24, 2024

Study Description

This is a parallel, two-arm, double-blind, randomized placebo-controlled 2-week trial investigating the effects of pramipexole 0.25-0.5 mg on Restless Legs Syndrome (RLS) symptoms in patients suffering from opioid withdrawal. The investigators hypothesize that pramipexole is an effective treatment for RLS symptoms in Opioid Use Disorder (OUD) patients during post-detox clinical stabilization. Further, the investigators hypothesize that treatment of RLS in this context will also improve overall symptoms of opioid withdrawal.

RLS is a sensory-motor neurological disorder characterized by an irresistible urge to move the legs. The investigators have recently confirmed anecdotal reports that RLS is common among patients with OUD experiencing opioid withdrawal. Dopamine agonists such as pramipexole are efficacious and first-line FDA-approved treatments in low doses for RLS.

Recruitment and enrollment will occur at the Gavin Foundation Clinical Stabilization Services (CSS) in Quincy, Massachusetts. Eligible patients will be randomized to two weeks of pramipexole or placebo after an initial 3-day screening period and will be asked to complete 5 remote study visits over video or phone. Participants will be asked to complete sleep diaries and questionnaires at various points throughout the study.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Gavin Foundation Clinical Stabilization Services

    Quincy, Massachusetts 02170
    United States

    Site Not Available

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