Trial · NCT04759703

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

NCT04759703, Phase 2, Phase 3, Terminated, Massachusetts General Hospital; results first posted 2025-09-22

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD. Trials, record NCT04759703. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04759703

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Treatment of Restless Legs Symptoms With Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD
NCT number: NCT04759703
Status: Terminated
Phases: Phase 2, Phase 3
Enrollment: 75 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Sleep Disorder, Restless Legs Syndrome, Opioid-use Disorder, Opioid Withdrawal
Interventions: Pramipexole, Placebo
First posted: 2021-02-18
Last updated: 2025-09-22
Results first posted: 2025-09-22
Limitations and caveats: This study was terminated early and did not complete planned enrollment. There was a target enrollment of 160, but the study only got to 75 enrolled. Of those 75, only 40 received treatment (20 pramipexole, 20 placebo). Limited sample size limits reliability of analyses and adverse events may not be representative of the broader study population.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline International RLS Severity Score (IRLS) at 2 Weeks	baseline and 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
Secondary	Change From Baseline Subjective Opiate Withdrawal Scale (SOWS) at 2 Weeks	baseline and 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)

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Change From Baseline Subjective Opiate Withdrawal Scale (SOWS) at 2 Weeks	baseline and 2 weeks		scores on a scale	MEAN
PRIMARY	Change From Baseline International RLS Severity Score (IRLS) at 2 Weeks	baseline and 2 weeks		scores on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline Subjective Opiate Withdrawal Scale (SOWS) at 2 Weeks	Pramipexole	-11.60	Standard Deviation 11.88	scores on a scale
Change From Baseline Subjective Opiate Withdrawal Scale (SOWS) at 2 Weeks	Placebo	-18.28	Standard Deviation 13.41	scores on a scale
Change From Baseline International RLS Severity Score (IRLS) at 2 Weeks	Pramipexole	-7.04	Standard Deviation 3.44	scores on a scale
Change From Baseline International RLS Severity Score (IRLS) at 2 Weeks	Placebo	-9.15	Standard Deviation 6.56	scores on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pramipexole	20
Overall Study	STARTED	Placebo	20
Overall Study	COMPLETED	Pramipexole	13
Overall Study	COMPLETED	Placebo	11
Overall Study	NOT COMPLETED	Pramipexole	7
Overall Study	NOT COMPLETED	Placebo	9

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Stomach cramps	Gastrointestinal disorders	Pramipexole	4	20
other	Stomach cramps	Gastrointestinal disorders	Placebo	3	20
other	Constipation	Gastrointestinal disorders	Pramipexole	2	20
other	Constipation	Gastrointestinal disorders	Placebo	0	20
other	Nausea	Gastrointestinal disorders	Pramipexole	4	20
other	Nausea	Gastrointestinal disorders	Placebo	1	20
other	Headaches	Nervous system disorders	Pramipexole	2	20
other	Headaches	Nervous system disorders	Placebo	1	20
other	Worsened RLS	Nervous system disorders	Pramipexole	1	20
other	Worsened RLS	Nervous system disorders	Placebo	0	20

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pramipexole	0	20
Total, all-cause mortality	Placebo	0	20
Total, other adverse events	Pramipexole	15	20
Total, other adverse events	Placebo	8	20
Total, serious adverse events	Pramipexole	0	20
Total, serious adverse events	Placebo	0	20

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
3687892	BACKGROUND	PubMed
14592342	BACKGROUND	PubMed
17644424	BACKGROUND	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21DA052861	Treatment of Restless Legs Symptoms with Pramipexole to Improve the Outcomes of Protracted Opioid Withdrawal in OUD: A Pilot Double-blind, Randomized Clinical Trial	WINKELMAN, JOHN W	MASSACHUSETTS GENERAL HOSPITAL	NATIONAL INSTITUTE ON DRUG ABUSE	2021 to 2022

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Pramipexole vs Placebo: deaths from any cause	Trial comparisons
Pramipexole vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04759703

GET https://conductscience.org/api/trials/v1/NCT04759703/registered

API reference For AI assistants