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Dopamine Agonist

Pramipexole for Opioid Withdrawal Syndrome

Phase 2 & 3

Recruiting

Led By John W Winkelman, MD/PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

International Restless Legs Syndrome Severity Scale (IRLS) Symptoms subscale score of >15 for three consecutive days prior to randomization

Age 18-75 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

Study Summary

This trial will test if pramipexole can help reduce symptoms of Restless Legs Syndrome and protracted opioid withdrawal in patients with Opioid Use Disorder, to help them stay in treatment.

Who is the study for?

This trial is for adults aged 18-75 with Opioid Use Disorder who've completed initial detox but still have withdrawal symptoms. They must also suffer from Restless Legs Syndrome, be willing to follow the study plan, and not have severe kidney issues, certain neurological or heart diseases, a history of RLS treatment with dopamine drugs, recent use of specific medications or substance dependencies.Check my eligibility

What is being tested?

The study tests Pramipexole's effectiveness in reducing Restless Legs Syndrome symptoms and lingering opioid withdrawal effects to help patients stick with their Opioid Use Disorder treatment. Participants will either receive Pramipexole or a placebo without knowing which one they're getting.See study design

What are the potential side effects?

Pramipexole may cause dizziness, nausea, sleepiness, sudden sleep onset during daily activities (without warning), hallucinations (seeing/hearing things that are not there), confusion and other side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My restless legs syndrome has been severe for the last three days.

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline International Restless Legs Syndrome Study Group Scale (IRLS) at 2 weeks

Secondary outcome measures

Change from Baseline Subjective Opiate Withdrawal Scale (SOWS) at 2 weeks

Side effects data

From 2017 Phase 4 trial • 52 Patients • NCT02033369

82%

nausea

59%

headache

50%

somnolence

45%

Lightheadedness

45%

Dry Mouth

41%

Insomnia

41%

Restlessness

36%

Dizziness

32%

Forgetfulness

32%

Vomiting

32%

Heartburn

32%

decreased libido

27%

Blurry Vision

27%

Decreased Appetite

27%

Increased Appetite

23%

Diarrhea

23%

Sleep Attacks

23%

Skin Problems

18%

Constipation

18%

Sweating

18%

Impaired Coordination

14%

Sexual Dysfunction

14%

compulsive behaviorws

Bruising

tremor

Impaired Concentration

fatigue

100%

80%

60%

40%

20%

Study treatment Arm

MDD Patients

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PramipexoleExperimental Treatment1 Intervention

Medication arm; 0.25 or 0.5 mg of pramipexole

Group II: PlaceboPlacebo Group1 Intervention

Placebo arm; 0.25 or 0.5 mg of placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pramipexole

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,421 Total Patients Enrolled

John W Winkelman, MD/PhDPrincipal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

108 Total Patients Enrolled

Media Library

Pramipexole (Dopamine Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04759703 — Phase 2 & 3

Opioid Use Disorder Research Study Groups: Pramipexole, Placebo

Opioid Use Disorder Clinical Trial 2023: Pramipexole Highlights & Side Effects. Trial Name: NCT04759703 — Phase 2 & 3

Pramipexole (Dopamine Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04759703 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the participants in this study all adults?

"This trial is available to patients that are aged 18 or older, but no more than 75 years old."

Answered by AI

I am interested in enrolling myself in this test, what are the requirements?

"This trial is only considering patients that have restless legs syndrome and are between 18-75 years old. So far, they have recruited around 80 people but need more participants to continue the study."

Answered by AI

To the best of your knowledge, are there other ongoing research projects studying Pramipexole?

"As of now, there are three ongoing clinical trials investigating Pramipexole with one in Phase 3. The majority of these medical studies take place in Bhubaneswar, Orissa; however, there are four total locations running these sorts of tests."

Answered by AI

Are there any available positions for test subjects in this experiment?

"No, this specific trial is not currently searching for new patients. However, according to the data hosted on clinicaltrials.gov, there are 1322 other trials that are still recruiting."

Answered by AI