Study 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.
Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD
2 other identifiers
interventional
75
1 country
2
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 withdrawal and thereby promote initiation, engagement, and retention in treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedStudy Start
First participant enrolled
January 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2024
CompletedResults Posted
Study results publicly available
September 22, 2025
CompletedSeptember 22, 2025
September 1, 2025
2.3 years
February 12, 2021
September 12, 2025
September 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline International RLS Severity Score (IRLS) at 2 Weeks
The International Restless Legs Syndrome Study Group Rating Scale (IRLS) is a 10-item patient-reported questionnaire designed to assess the severity of restless legs syndrome symptoms. Each item is scored from 0 (no symptoms) to 4 (very severe), for a total score range of 0 to 40, with higher scores indicating greater symptom severity. A negative change from baseline represents symptom improvement. Very severe=31-40 points Severe=21-30 points Moderate=11-20 points Mild=1-10 points None=0 points Change 2 weeks IRLS score minus baseline IRLS score
baseline and 2 weeks
Secondary Outcomes (1)
Change From Baseline Subjective Opiate Withdrawal Scale (SOWS) at 2 Weeks
baseline and 2 weeks
Study Arms (2)
Pramipexole
EXPERIMENTALMedication arm; 0.25 of pramipexole
Placebo
PLACEBO COMPARATORPlacebo arm; 0.25 mg of placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Gavin Foundation Clinical Stabilization Services
Quincy, Massachusetts, 02170, United States
Related Publications (3)
Handelsman L, Cochrane KJ, Aronson MJ, Ness R, Rubinstein KJ, Kanof PD. Two new rating scales for opiate withdrawal. Am J Drug Alcohol Abuse. 1987;13(3):293-308. doi: 10.3109/00952998709001515.
PMID: 3687892BACKGROUNDWalters AS, LeBrocq C, Dhar A, Hening W, Rosen R, Allen RP, Trenkwalder C; International Restless Legs Syndrome Study Group. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med. 2003 Mar;4(2):121-32. doi: 10.1016/s1389-9457(02)00258-7.
PMID: 14592342BACKGROUNDHening WA, Allen RP, Washburn M, Lesage S, Earley CJ. Validation of the Hopkins telephone diagnostic interview for restless legs syndrome. Sleep Med. 2008 Mar;9(3):283-9. doi: 10.1016/j.sleep.2007.04.021. Epub 2007 Jul 17.
PMID: 17644424BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early and did not complete planned enrollment. There was a target enrollment of 160, but the study only got to 75 enrolled. Of those 75, only 40 received treatment (20 pramipexole, 20 placebo). Limited sample size limits reliability of analyses and adverse events may not be representative of the broader study population.
Results Point of Contact
- Title
- John W. Winkelman, MD, PhD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
John W Winkelman, MD/PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Sleep Disorders Clinical Research Program
Study Record Dates
First Submitted
February 12, 2021
First Posted
February 18, 2021
Study Start
January 24, 2022
Primary Completion
May 24, 2024
Study Completion
May 24, 2024
Last Updated
September 22, 2025
Results First Posted
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Per the NIH Policy on Data Sharing, the investigators will make the datasets available to other investigators following publication of the final study results.
- Access Criteria
- Requests must be in accordance with Mass General Brigham Policies and Harvard Medical School Guidelines.
The investigators will make data available on a public database. Outside investigators should submit their request in writing to the PI. A data-sharing agreement will be required. The request must be in accordance with Mass General Brigham (MGB) Policies and Harvard Medical School (HMS) Guidelines. Such datasets will not contain identifying information per the regulations outlined in HIPPA, and permission will be obtained from study participants to share their data with researchers outside MGB. Per standard MGB policies, the investigators will require a data-sharing agreement from any investigator or entity requesting the data; this agreement will include: (i) a commitment to using the data only for research purposes and not to identify any individual participant; (ii) a commitment to securing the data using appropriate computer technology; and (iii) a commitment to destroying or returning the data after analyses are completed.