A Phase 2/3 interventional study of Pramipexole and Placebo in Sleep Disorder, Restless Legs Syndrome and Opioid-use Disorder, sponsored by Massachusetts General Hospital. Terminated at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by Massachusetts General Hospital · Phase 2/3, Interventional, and Treatment
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.
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.
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's enrollment of 75 is above the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Medication arm; 0.25 of pramipexole
Drug: Pramipexole
Placebo arm; 0.25 mg of placebo
Drug: Placebo
0.25 mg pramipexole tablets
Also known as: Mirapex
Matching placebo tablets
Change From Baseline International RLS Severity Score (IRLS) at 2 Weeks
The International Restless Legs Syndrome Study Group Rating Scale (IRLS) is a 10-item patient-reported questionnaire designed to assess the severity of restless legs syndrome symptoms. Each item is scored from 0 (no symptoms) to 4 (very severe), for a total score range of 0 to 40, with higher scores indicating greater symptom severity. A negative change from baseline represents symptom improvement. Very severe=31-40 points Severe=21-30 points Moderate=11-20 points Mild=1-10 points None=0 points Change 2 weeks IRLS score minus baseline IRLS score
Time frame: baseline and 2 weeks
Change From Baseline Subjective Opiate Withdrawal Scale (SOWS) at 2 Weeks
The Subjective Opiate Withdrawal Scale (SOWS) is a 16-item self-administered instrument. Self-administered scale for grading opioid withdrawal symptoms. Scored from 0-64. Summed from 16 sub-scale questions rated by the patient from 0 to 4. Mild Withdrawal = score of 1 - 10 Moderate withdrawal = 11 - 20 Severe withdrawal = 21 - 30+ Change in SOWS score (2 weeks minus baseline)
Time frame: baseline and 2 weeks
Participants were recruited from the Gavin Foundation Clinical Stabilization Services in Quincy. A total of 175 patients were referred, 93 were screened, and 75 patients enrolled.
| Milestone | Pramipexole | Placebo |
|---|---|---|
| Started | 20 | 20 |
| Completed | 13 | 11 |
| Not completed | 7 | 9 |
| Withdrew: Withdrawal by subject | 4 | 9 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 |
The Subjective Opiate Withdrawal Scale (SOWS) is a 16-item self-administered instrument. Self-administered scale for grading opioid withdrawal symptoms. Scored from 0-64. Summed from 16 sub-scale questions rated by the patient from 0 to 4. Mild Withdrawal = score of 1 - 10 Moderate withdrawal = 11 - 20 Severe withdrawal = 21 - 30+ Change in SOWS score (2 weeks minus baseline)
| scores on a scale | Pramipexole | Placebo |
|---|---|---|
| Change From Baseline Subjective Opiate Withdrawal Scale (SOWS) at 2 Weeks | -11.60 ± 11.88 | -18.28 ± 13.41 |
The International Restless Legs Syndrome Study Group Rating Scale (IRLS) is a 10-item patient-reported questionnaire designed to assess the severity of restless legs syndrome symptoms. Each item is scored from 0 (no symptoms) to 4 (very severe), for a total score range of 0 to 40, with higher scores indicating greater symptom severity. A negative change from baseline represents symptom improvement. Very severe=31-40 points Severe=21-30 points Moderate=11-20 points Mild=1-10 points None=0 points Change 2 weeks IRLS score minus baseline IRLS score
| scores on a scale | Pramipexole | Placebo |
|---|---|---|
| Change From Baseline International RLS Severity Score (IRLS) at 2 Weeks | -7.04 ± 3.44 | -9.15 ± 6.56 |
Collected over From enrollment through study termination, up to 2 weeks after randomization. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pramipexole | 0/20 (0%) | 0/20 (0%) | 15/20 (75%) |
| Placebo | 0/20 (0%) | 0/20 (0%) | 8/20 (40%) |
| Event | Pramipexole | Placebo |
|---|---|---|
| Stomach crampsGastrointestinal disorders | 4/20 | 3/20 |
| NauseaGastrointestinal disorders | 4/20 | 1/20 |
| DrowsinessGeneral disorders | 3/20 | 1/20 |
| Vivid DreamsPsychiatric disorders | 3/20 | 0/20 |
| ConstipationGastrointestinal disorders | 2/20 | 0/20 |
| HeadachesNervous system disorders | 2/20 | 1/20 |
| Dry MouthGastrointestinal disorders | 0/20 | 2/20 |
| Worsened RLSNervous system disorders | 1/20 | 0/20 |
| JumpinessNervous system disorders | 0/20 | 1/20 |
| Muscle twitchesNervous system disorders | 0/20 | 1/20 |
Of 75 enrolled, 35 participants Withdrew/Failed before baseline data collected
| Age, Continuous(Years) | Pramipexole | Placebo | Total |
|---|---|---|---|
| Mean | 39.1 ± 9.6 | 35.2 ± 5.8 | 37.3 ± 8.2 |
| Sex: Female, Male(Participants) | Pramipexole | Placebo | Total |
|---|---|---|---|
| Female | 7 | 3 | 10 |
| Male | 13 | 17 | 30 |
| Race (NIH/OMB)(Participants) | Pramipexole | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 15 | 17 | 32 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Pramipexole | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 3 | 4 |
| Not Hispanic or Latino | 19 | 17 | 36 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Pramipexole | Placebo | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
| Subjective Opiate Withdrawal Scale (SOWS)(scores on a scale) | Pramipexole | Placebo | Total |
|---|---|---|---|
| Mean | 21.18 ± 10.00 | 26.40 ± 10.61 | 23.93 ± 10.52 |
| International Restless Legs Syndrome Study Group Rating Scale (IRLS)(scores on a scale) | Pramipexole | Placebo | Total |
|---|---|---|---|
| Mean | 14.94 ± 1.99 | 14.71 ± 1.89 | 14.85 ± 1.92 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The investigators will make data available on a public database. Outside investigators should submit their request in writing to the PI. A data-sharing agreement will be required. The request must be in accordance with Mass General Brigham (MGB) Policies and Harvard Medical School (HMS) Guidelines. Such datasets will not contain identifying information per the regulations outlined in HIPPA, and permission will be obtained from study participants to share their data with researchers outside MGB. Per standard MGB policies, the investigators will require a data-sharing agreement from any investigator or entity requesting the data; this agreement will include: (i) a commitment to using the data only for research purposes and not to identify any individual participant; (ii) a commitment to securing the data using appropriate computer technology; and (iii) a commitment to destroying or returning the data after analyses are completed.
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