Recruiting

Buprenorphine & Methadone

Sponsor:

Baystate Medical Center

Code:

NCT06527820

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Talk About It (conversation aid)

Study Details

Brief summary:

The increasing morbidity and mortality of the opioid epidemic has necessitated a reevaluation of current addiction treatment paradigms: medications for opioid use disorder, such as buprenorphine and methadone, are effective in decreasing one's risk of death and disability from opioid use, but are underutilized and often difficult to access. The 5000 Emergency Departments (EDs) in the US are potential additional locales for medication initiation, but currently only a small minority of ED patients with opioid use disorder are started on medications. This study will refine and pilot an intervention called Talk About It which aims to foster patient-centered care, 'meet patients where they are' for addiction treatment, and increase treatment initiation and adherence via facilitating Shared Decision-Making in the ED around these potentially life-saving options.

Conditions

Opioid Use Disorder

Study ID

NCT06527820

Start date

Jun 1, 2024

Status verified date

Jul, 2024

Completion date

Aug 30, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients aged 16 and older
  • presenting with indications for Medications for Opioid Use Disorder (MOUD) initiation (opioid overdose, opioid withdrawal, complications of injection opioid use, untreated OUD)
  • not currently on buprenorphine or methadone (in the past 7 days).

(Buprenorphine is FDA approved for patients aged 16 and older, so 16- and 17-year-olds may be included with parental consent.)

Exclusion Criteria:

  • No Opioid Use Disorder (OUD)
  • already on MOUD

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Talk About It (conversation aid)

"Talk About It" is a conversation aid aimed to increase awareness of options and prompt discussion.

Primary outcome measure

  • Uptake of Talk About It (1) [ Time Frame: At 18 months ]
  • Uptake of Talk About It (2) [ Time Frame: At 6-18 months ]
  • Uptake of Talk About It (3) [ Time Frame: At 6-18 months ]
  • Uptake of Talk About It (4) [ Time Frame: At 6-18 months ]
  • Medications for Opioid Use Disorder (MOUD) initiation [ Time Frame: From 0-24 months ]
  • Recruitment: Clinician enrollment [ Time Frame: From 0-12 months ]
  • Recruitment: Patient enrollment [ Time Frame: From 0-24 months ]
  • Acceptability/Feasibility of Talk About It [ Time Frame: At 6 and 18 months ]

Central Contacts and Locations

Central contacts

Elizabeth Schoenfeld, MD, MS

4137940000elizschoen@gmail.com

Locations

Baystate Medical Center

Recruiting

Springfield, Massachusetts, United States, 01199

Contacts

Jillian Tozloski

Jillian.Tozloski@baystatehealth.org

More Information

Sponsor

Baystate Medical Center

Last update posted

Jul 31, 2024

Last verified

Jul, 2024

Keywords

  • shared decision-making
  • decision aid
  • conversation aid
  • patient-centered care
  • addiction
  • emergency medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baystate Medical Center on 2024-07-31.