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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04759703

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disorder Restless Legs Syndrome Opioid-use Disorder Opioid Withdrawal	Drug: Pramipexole Drug: Placebo	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pramipexole Medication arm; 0.25 or 0.5 mg of pramipexole	Drug: Pramipexole 0.25 mg pramipexole tablets Other Names: Mirapex
Placebo Comparator: Placebo Placebo arm; 0.25 or 0.5 mg of placebo	Drug: Placebo Matching placebo tablets

Arm

Intervention/Treatment

Experimental: Pramipexole

Medication arm; 0.25 or 0.5 mg of pramipexole

Drug: Pramipexole

0.25 mg pramipexole tablets

Other Names:

Mirapex

Placebo Comparator: Placebo

Placebo arm; 0.25 or 0.5 mg of placebo

Drug: Placebo

Matching placebo tablets

Outcome Measures

Primary Outcome Measures

Change from Baseline International Restless Legs Syndrome Study Group Scale (IRLS) at 2 weeks [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 [2 weeks]
The Subjective Opiate Withdrawal Scale (SOWS) is a 16-item self-administered instrument. One of the items queries for presence of 'restlessness'.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Gavin Foundation Clinical Stabilization Services	Quincy	Massachusetts	United States	02170