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Résztvevőt keres itt: Egyesült Államok3. fázis

Emergency Department-Initiated Medications for Alcohol Use Disorder

A legfontosabb adatok

Ki végzi
Yale University
Hol
New Haven (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Toboroz
Fázis
3. fázis
Résztvevők
240 fő, tervezett
Kezdés
2024. aug. 17.
Várható befejezés
2029. febr. 1.
A vizsgálat típusa
Beavatkozással járó, 2 csoport
A vizsgált kezelések
  • Naltrexone Pill
  • Naltrexone Injection
  • Brief Negotiation Interview
  • Gabapentin Pill
A regiszteradat frissítve
2026. július 21.

Ki vehet részt

Életkor
18 év – 80 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 23 feltétel megnézéseKevesebb

Ki vehet részt

  • Between 18 and 80 years in age
  • Diagnosed with moderate to severe Alcohol Use Disorder
  • Stated willingness and ability to comply with all study procedures and availability for the duration of the study
  • Reproductive aged females will have a negative pregnancy test within the past 24 hours and agree to use of highly effective family planning during study participation period
  • Able to speak English sufficiently to understand study procedures and provide written informed consent to participate in the study
  • Clinical Alcohol Withdrawal Scale (CIWA-Ar) ≥ 4

Ki nem vehet részt

  • A current diagnosis of OUD, self-reported past 7 day opioid or opioid pain medication use, or a positive urine opioid screen (opiates, methadone, buprenorphine, oxycodone, hydrocodone, tramadol and fentanyl)
  • Current prescription of opioid pain medications, or anticipated need for opioid pain medications during the study period (i.e. planned surgery)
  • Previously enrolled in this study or currently enrolled in another study for which they are currently receiving study medications or active ongoing intervention
  • Past week treatment with medications for the treatment of alcohol use disorder
  • History of complicated alcohol withdrawal
  • Condition that precludes interview (i.e., life threatening injury/illness)
  • Inability to consent due to cognitive impairment
  • Awaiting an acute psychiatric evaluation for psychosis or suicidal ideation
  • Any contraindication to naltrexone or gabapentin, including known allergy, renal failure, acute hepatitis, hepatic failure,1 or severe lung disease or other chronic conditions such as chronic obstructive pulmonary disease (COPD)
  • Creatine Clearance <60 mL/min within past 72 hours
  • In police custody
  • Unable to provide contact information
  • Currently pregnant or breast feeding
  • Requiring hospitalization at the time of the index visit
  • Taking gabapentin or naltrexone for any reason
  • Appearing unable or unwilling to comply with discharge instructions or complete follow-up
  • Current residence outside of the state of Connecticut

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 80 év között vagy?

Helyszínek itt: Egyesült Államok

  • Yale New Haven HospitalNew Haven, Egyesült ÁllamokContact: Kathryn Hawk, MD, MHSRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

The proposed study will be the first randomized clinical trial to evaluate a comprehensive Emergency Department (ED)-based intervention for moderate to severe Alcohol Use Disorder (AUD) combining Screening, Brief Intervention and Referral to Treatment (SBIRT) with ED-initiated medications for treatment of alcohol use disorder (MAUD).

A teljes eredeti leírásKevesebb

The primary objective of this phase 3 study is to evaluate for differences in treatment engagement 30 days after ED visit between emergency department patients with moderate to severe alcohol use disorder (AUD) who are randomized to initiate medications for the treatment for AUD in the ED in addition to receiving a brief intervention and referral to ongoing treatment, which all participants will receive.

The secondary objective of this study is to evaluate the difference in reduction of heavy drinking days between the two ED treatment models during the 30 days post ED visit.

A vizsgálat 2 csoportja

  • SBIRTA vizsgált kezelés

    Participants will receive the Brief Negotiation Interview (BNI) and Referral to Treatment. The BNI has four key components: (1) permission to discuss substance use, (2) feedback on the health consequences of ongoing substance use, including making a connection between the ED visit and substance use, (3) motivational enhancement, and (4) negotiation and advice.

    Kezelés: Brief Negotiation Interview

  • SBIRT+ED-MAUDA vizsgált kezelés

    Participants with receive BNI, Referral to Treatment, and MAUD. In the MAUD component, either XR-NTX or oral naltrexone will be provided, supplemented by ancillary treatment with gabapentin. Participants will receive their first doses of XR-NTX (injection) and gabapentin in the ED and will receive 7 days of gabapentin take-home doses. Those who prefer to initiate treatment in ED with oral naltrexone receive their first doses of naltrexone and gabapentin in the ED and receive 29-day take-home doses of naltrexone and 7 days of gabapentin.

    Kezelés: Naltrexone Pill, Naltrexone Injection, Brief Negotiation Interview és Gabapentin Pill

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Illeszkedési kérdések
Forrás: NCT05827159: ki vehet részt
A regiszteradat frissítve
2026. július 21.