Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid… (NCT04759703) | Clinical Trial Compass
TerminatedPhase 2/3
Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD
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.
United States75 participantsStarted 2022-01-24
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
✕
What they're measuring
1
Change From Baseline International RLS Severity Score (IRLS) at 2 Weeks
. 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