Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT04759703
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04759703
Study Brief:
Protocol Section:
NCT04759703