Status:
TERMINATED
Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Sleep Disorder
Restless Legs Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief 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 w...
Detailed 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 sufferin...
Eligibility Criteria
Inclusion
- Men or women of any ethnic origin.
- Written informed consent is obtained
- Speaks and writes in English
- A willingness and ability to comply with study procedures.
- Age 18-75 years
- 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
- Diagnosis of RLS from the Hening Telephone Diagnostic Interview (HTDI) with subsequent confirmation by clinical interview conducted by a study physician
- International Restless Legs Syndrome Severity Scale (IRLS) Symptoms subscale score of \>15 for three consecutive days prior to randomization
Exclusion
- Receiving opioid-agonist medications at transfer to the CSS
- Pregnant
- Participants with active or unstable major psychiatric disorder other than OUD, who, in the investigators' judgment, require further treatment
- Use of dopaminergic agonists or antagonists within the last 30 days
- Alcohol use disorder within the last 30 days
- History of being treated for RLS, specifically with dopamine agonist medications
- Methamphetamine or benzodiazepine dependence in the last 30 days
- 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
- Medical instability considered to interfere with study procedures
- Stage 3, 4, or 5 renal insufficiency
- Participation in this study on a previous admission to the CSS
Key Trial Info
Start Date :
January 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04759703
Start Date
January 24 2022
End Date
May 24 2024
Last Update
September 22 2025
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Gavin Foundation Clinical Stabilization Services
Quincy, Massachusetts, United States, 02170