Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD
Reason given: An interim analysis indicated that we would need to enroll more subjects than our initial enrollment target, in order to demonstrate a significant treatment effect. Due to these results, we have decided to terminate this protocol.
Key facts
- Where
- Boston and Quincy, United StatesSee the 2 sites
- Phase
- Phase 2/3
Where in United States
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Gavin Foundation Clinical Stabilization ServicesQuincy, United StatesNo longer taking part
Trial details
- Who runs it
- Massachusetts General Hospital
- Trial code
- NCT04759703
- Record updated
- 22 September 2025
- Original description
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.Read full original descriptionShow less
Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD: A Pilot Double-blind, Randomized Clinical Trial
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.
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; Participation in this study on a previous admission to the CSS; Participants with active or unstable major psychiatric disorder other than OUD, who, in the investigators' judgment, require further treatment; Alcohol use disorder within the last 30 days; History of being treated for RLS, specifically with dopamine agonist medications; 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; Stage 3, 4, or 5 renal insufficiency; Pregnant; Use of dopaminergic agonists or antagonists within the last 30 days; Methamphetamine or benzodiazepine dependence in the last 30 days; Medical instability considered to interfere with study procedures.