Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759703
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2021-02-12
Brief Title:
Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 025-05 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None