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Can a device replace pills for opioid withdrawal?

NCT ID NCT04325659

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device called the Bridge, which uses mild electrical pulses to ease opioid withdrawal symptoms. 36 adults with opioid addiction were randomly assigned to get the active device, withdrawal medication (lofexidine), or a placebo. The goal was to see if the device could reduce withdrawal severity and keep people in treatment. Results could offer a new, drug-free way to manage withdrawal.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bridge Device (neuromodulator device) and lofexidine (medication)
What this could lead to
If successful, this could provide a non-drug option for managing opioid withdrawal, potentially improving treatment retention and reducing relapse.
What could go wrong
This is a small, early-phase trial with only 36 participants. The device was cleared based on safety, not proven efficacy, so it may not work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

36 people

The number who actually took part.

Started

Nov 2020

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age between 18 and 65 years old * Meets Diagnostic and Statistical Manual-5 criteria for Opioid Use Disorder (OUD) (moderate or severe) based upon Mini-International Neuropsychiatric Interview (MINI) * Provides a urine sample that tests positive for opioids during screening or have evidence of opioid withdrawal * Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests * No significant psychiatric illnesses besides OUD * Seeking treatment to stop using illicit opioids * Willing to comply with the study protocol * Have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation Exclusion Criteria: * Pregnant or breast feeding * Receiving opioid agonist treatment * Significant medical illness (e.g., insulin dependent diabetes) * Significant psychiatric illness (e.g., schizophrenia) * Use of medical cannabis * Contraindications for use of the Bridge Device, morphine, lofexidine or naloxone (e.g., hemophilia, psoriasis and other skin conditions, a cardiac pacemaker) * Have evidence of physical dependence on alcohol or benzodiazepines that requires medical detoxification * Hypotension (diastolic blood pressure of less than 60 mm Hg or systolic blood pressure of less than 90 mm Hg on screening examination) * Prolonged corrected QT interval interval on screening ECG (defined as \>0.44 seconds for males and \>0.46 seconds for females) * Hepatic or renal impairment, as indicated by the following lab results at the screening session: * Aspartate aminotransferase or alanine transaminase \>3x upper limit of normal (ULN) * Total Bilirubin \>2x ULN. * Creatinine \>1.5x ULN. * Treatment with a strong 2D6 inhibitor (e.g., paroxetine, thioridazine, cinacalcet, bupropion, methotrimeprazine, fluoxetine, midostaurin, propafenone, glycerol phenylbutyrate, halofantrine, cisapride, dacomitinib, orphenadrine, quinidine) * Have a known allergy to any of the study medications * Have circumstances that would interfere with study participation (e.g., impending jail)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Behavioral Pharmacology Research Unit

    Baltimore, Maryland, 21224, United States

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