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

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Pramipexole

Criteria

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