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

Primary Purpose

Sleep Disorder, Restless Legs Syndrome, Opioid-use Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pramipexole
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorder focused on measuring Pramipexole

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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
  7. Diagnosis of RLS from the Hening Telephone Diagnostic Interview (HTDI) with subsequent confirmation by clinical interview conducted by a study physician
  8. International Restless Legs Syndrome Severity Scale (IRLS) Symptoms subscale score of >15 for three consecutive days prior to randomization

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 of pramipexole and/or judged to interfere with ability to assess efficacy of the treatment
  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

Sites / Locations

  • Massachusetts General Hospital
  • Gavin Foundation Clinical Stabilization ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pramipexole

Placebo

Arm Description

Medication arm; 0.25 or 0.5 mg of pramipexole

Placebo arm; 0.25 or 0.5 mg of placebo

Outcomes

Primary Outcome Measures

Change from Baseline International Restless Legs Syndrome Study Group Scale (IRLS) at 2 weeks
A validated tool to measure restless legs syndrome severity, on a scale of 0-40, with a higher score representing greater restless legs syndrome severity

Secondary Outcome Measures

Change from Baseline Subjective Opiate Withdrawal Scale (SOWS) at 2 weeks
The Subjective Opiate Withdrawal Scale (SOWS) is a 16-item self-administered instrument. One of the items queries for presence of 'restlessness'.

Full Information

First Posted
February 12, 2021
Last Updated
February 13, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04759703
Brief Title
Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD
Official Title
Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD: A Pilot Double-blind, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder, Restless Legs Syndrome, Opioid-use Disorder, Opioid Withdrawal
Keywords
Pramipexole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pramipexole
Arm Type
Experimental
Arm Description
Medication arm; 0.25 or 0.5 mg of pramipexole
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo arm; 0.25 or 0.5 mg of placebo
Intervention Type
Drug
Intervention Name(s)
Pramipexole
Other Intervention Name(s)
Mirapex
Intervention Description
0.25 mg pramipexole tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablets
Primary Outcome Measure Information:
Title
Change from Baseline International Restless Legs Syndrome Study Group Scale (IRLS) at 2 weeks
Description
A validated tool to measure restless legs syndrome severity, on a scale of 0-40, with a higher score representing greater restless legs syndrome severity
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline Subjective Opiate Withdrawal Scale (SOWS) at 2 weeks
Description
The Subjective Opiate Withdrawal Scale (SOWS) is a 16-item self-administered instrument. One of the items queries for presence of 'restlessness'.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin W Wipper
Phone
617-643-6026
Email
bwipper@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W Winkelman, MD/PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Wipper
Phone
617-643-6026
Email
bwipper@mgh.harvard.edu
Facility Name
Gavin Foundation Clinical Stabilization Services
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02170
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Wipper
Phone
617-643-6026
Email
bwipper@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
Requests must be in accordance with Mass General Brigham Policies and Harvard Medical School Guidelines.
Citations:
PubMed Identifier
3687892
Citation
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.
Results Reference
background
PubMed Identifier
14592342
Citation
Walters 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.
Results Reference
background
PubMed Identifier
17644424
Citation
Hening 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.
Results Reference
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Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD

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