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Primary care teams take on substance use: new study tests collaborative model

NCT ID NCT06116266

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a collaborative care model—where a nurse care manager works with your primary care doctor and an addiction specialist—can help adults reduce their use of opioids, stimulants (like cocaine or meth), and heavy drinking. About 300 patients from primary care clinics will take part. The goal is to see if this team approach leads to fewer days of substance use and better overall recovery.

What this could mean

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

Active substance
Collaborative care intervention (education, nurse care manager, addiction specialist consultation)
What this could lead to
If successful, this could provide an effective way to manage substance use disorders in primary care, reducing drug and alcohol use.
What could go wrong
This is a relatively small trial (301 participants) testing a behavioral intervention, not a drug. Results may not apply to all settings, and the effect may be modest.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

301 people

The number who actually took part.

Started

Jan 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

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 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

PCP Inclusion Criteria: * Licensed medical professional (MD, DO, NP, PA) who is able to prescribe controlled substances (Schedule III), or medical trainee meeting the requirements below. * Serves as a primary care provider to adult patients (18 years of age and over) of the study clinic(s) during direct patient care sessions. * Willing to be randomized to either of the study conditions. a. Medical trainees (physicians who are residents or fellows), are eligible if they have at least one continuity clinic session per week on average in the study clinic. Trainees must have plans to be working in a study clinic for approximately 8 months or longer. They must be able to provide prescriptions for controlled substances (Schedule III) either directly or through their preceptor(s). Patient Inclusion Criteria: * The participant's PCP is enrolled in the study. * Age 18 years or older. * Spoken and written proficiency in language of study materials, as determined by patient self-report and research staff evaluation. * Moderate to severe substance use disorder for opioids, stimulants, and/or alcohol, (defined as meeting four or more DSM-5 criteria per substance as measured on the CIDI-adapted for DSM-5). * a) Patients having alcohol use disorder without an opioid or stimulant SUD are required to have current opioid or stimulant use, as measured on the TAPS tool or baseline monthly survey. * Current polysubstance use, defined as self-reported use of two or more substances of concern in the past 30 days, at least one of which is required to be an opioid or stimulant. Substances of concern include opioids (illicit opioids, nonmedical use of prescription opioids), stimulants (cocaine, methamphetamine), alcohol (heavy drinking defined as more than 5 for men and 4 for women drinks on a single occasion), and benzodiazepines (nonmedical use). Nonmedical use includes using prescription medications more than prescribed, or that were not prescribed to the individual taking them. * Patients must report on the baseline monthly survey use in the past 30 days of at least one substance at or above the following thresholds: \>10 days for opioids; \>10 days for alcohol heavy drinking; \>7 days for stimulants. These minimum thresholds reflect levels of use that are typical for individuals with moderate to severe SUD, and are lower for stimulants than for opioids and alcohol to reflect the different patterns of use that are observed in prior trials. * Access to a reliable cell phone or willing to accept a phone as part of the incentive for completing the baseline visit (as determined by patient self-report). * Able to provide sufficient contact information (minimum of one locator). * Willing and able to provide written informed consent. PCP Exclusion Criteria: * Definite plan to resign from the clinic in the next eight months, per PCP self-report. Residents and fellows will need at least eight months before training completion to enroll. Patient Exclusion Criteria: * Currently being treated with medication for OUD (MOUD), and do not have moderate to severe AUD or StUD * Initiated MOUD treatment (buprenorphine, methadone, or XR-NTX) within the 30 days prior to screening, per patient self-report. Because substance use may fall rapidly with the initiation of MOUD, patients who recently started MOUD may already be in the process of making changes to their substance use that are not attributable to the intervention. * a) Initiation is defined as starting a new MOUD treatment episode, after not receiving MOUD treatment in the prior 30 days * Initiated a SUD treatment program within the 30 days prior to screening, per patient self-report. Because substance use may fall rapidly with the initiation of a treatment program, patients who recently initiated treatment may already be making changes to their substance use that are not attributable to the intervention. SUD treatment program includes outpatient or residential programs for alcohol/drug treatment; does not include detox or short-term inpatient episodes (\<15 days), or peer support (e.g., 12-Step Program such as AA/NA, Smart Recovery) * a) Initiation is defined as starting a new treatment episode, after not being in a SUD treatment program in the prior 30 days * Pregnancy, as determined by patient self-report. * Are currently in jail, prison, or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities * Definite plan to leave the area or the clinical practice within the next six months, per patient self-report. * Other factors that may cause harm or increased risk to the participant or close contacts or preclude the patient's full adherence with or completion of the study (e.g. unstable/severe acute mental illness).

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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

  • Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • Harris Health

    Houston, Texas, 77030, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Sea Mar Community Health Centers

    Bellingham, Washington, 98226, United States

  • The Institute for Family Health

    New York, New York, 10025, United States

  • Union Community Care

    Lancaster, Pennsylvania, 17603, United States

  • Winding Waters Medical Clinic

    Enterprise, Oregon, 97828, United States

  • Wisconsin Research & Education Network

    Madison, Wisconsin, 53705, United States

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