What side effects are associated with this type of intervention?

Common treatments for Opioid Use Disorder include medications such as methadone, buprenorphine, and naltrexone. Methadone and buprenorphine, both opioid agonists, can cause side effects like constipation, drowsiness, nausea, and potential for dependency. Naltrexone, an opioid antagonist, may lead to side effects such as nausea, headache, dizziness, and in some cases, liver toxicity. Pramipexole, a dopamine agonist, is being studied for its potential to alleviate symptoms of Restless Legs Syndrome and protracted opioid withdrawal, but common side effects of dopamine agonists include nausea, dizziness, somnolence, and the risk of sudden sleep attacks.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Opioid Use Disorder (OUD), including methadone, buprenorphine, and naltrexone. Methadone is a full opioid agonist, buprenorphine is a partial opioid agonist, and naltrexone is an opioid antagonist. These medications work by reducing cravings and withdrawal symptoms, thereby supporting recovery. While pramipexole, a dopamine agonist, is being studied for its potential to alleviate symptoms of Restless Legs Syndrome and protracted opioid withdrawal, it is not yet FDA-approved for OUD. The current FDA-approved treatments primarily target the opioid receptors, unlike pramipexole, which targets dopamine receptors.

What other types of research exist?

Promising novel alternatives to Pramipexole for Opioid Use Disorder patients include buprenorphine-naloxone buccal soluble film, which has shown efficacy in treating opioid dependence. Additionally, the use of medications like buprenorphine for chronic pain management and opioid tapering has been supported by recent studies. These alternatives offer a dual benefit of managing opioid dependence and associated symptoms.

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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

Must not have

Stage 3, 4, or 5 renal insufficiency

Receiving opioid-agonist medications at transfer to the CSS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

All Individual Drugs Already Approved

Summary

This trial tests pramipexole in patients with Opioid Use Disorder to see if it can reduce Restless Legs Syndrome and withdrawal symptoms. The goal is to help these patients start and stay in treatment programs. Pramipexole is a medication that has been used to treat Parkinson's disease and restless legs syndrome (RLS).

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.

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.

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.

Select...

I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is significantly reduced.

Select...

I am currently on opioid medication.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Methadone is a long-acting opioid agonist that reduces withdrawal symptoms and cravings by activating opioid receptors in the brain, thereby stabilizing the patient and preventing the euphoric effects of other opioids. Buprenorphine is a partial opioid agonist that also activates opioid receptors but to a lesser extent, which helps to reduce cravings and withdrawal symptoms while lowering the risk of misuse and overdose. Naltrexone is an opioid antagonist that blocks opioid receptors, preventing any opioid from producing euphoric effects, thus helping to maintain abstinence. Pramipexole, a dopamine agonist, is being studied for its potential to alleviate symptoms of Restless Legs Syndrome and protracted opioid withdrawal, which could improve treatment retention and outcomes. These treatments are crucial for OUD patients as they address both the physiological dependence on opioids and the psychological aspects of addiction, thereby supporting recovery and reducing the risk of relapse.

Complex Persistent Opioid Dependence with Long-term Opioids: a Gray Area That Needs Definition, Better Understanding, Treatment Guidance, and Policy Changes.Introduction: The specter of opiate addiction in reproductive medicine.Opioid use by patients in an orthopedics spine clinic.