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

> **NCT04759703** · PHASE2,PHASE3 · TERMINATED · sponsor: **Massachusetts General Hospital** · enrollment: 75 (actual)

## Conditions studied

- Sleep Disorder
- Restless Legs Syndrome
- Opioid-use Disorder
- Opioid Withdrawal

## Interventions

- **DRUG:** Pramipexole
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT04759703
- **Lead sponsor:** Massachusetts General Hospital
- **Sponsor class:** OTHER
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2022-01-24
- **Primary completion:** 2024-05-24
- **Final completion:** 2024-05-24
- **Target enrollment:** 75 (ACTUAL)
- **Why stopped:** 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.
- **Last updated:** 2025-09-22


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04759703

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04759703, "Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT04759703. Licensed CC0.

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