Developing a Tailored Stigma Reduction Intervention to Increase Buprenorphine Prescribing

NCT05505227 | Active Not Recruiting DMC

• 1 other identifier: 1R34DA057160
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Buprenorphine is an evidence-based treatment for opioid use disorder that also has strong potential to reduce HIV transmission in people who use drugs. Rural health care professionals are eligible and critically needed to provide these medications, but stigma currently limits provider willingness to prescribe buprenorphine, especially in regions where mortality and HIV transmission secondary to opioid use are high. In this developmental trial, the investigators will adapt, refine, and test the feasibility of a prototype brief stigma-reduction training intervention aimed at increasing buprenorphine prescribing in the rural primary care setting.

Conditions

Opioid-Related Disorders; Buprenorphine; Social Stigma; Rural Health Services

Outcome Measures

Primary Outcomes (4)

• Feasibility Intervention Measure

  Feasibility refers to the ease in which a new intervention can be used within a specific setting. It will be measured using the 4-item Feasibility Intervention Measure (FIM). Scale values range from 1 to 5 with higher values indicating a better outcome.

  Up to 6 months

• Acceptability

  Acceptability refers to HCP attitudes about whether the brief training intervention is agreeable or satisfactory. It is measured with the 4-item Acceptability of Intervention Measure (AIM) in HCP participants. Scale values range from 1 to 5 with higher values indicating a better outcome.

  Up to 6 months

• Appropriateness

  Appropriateness refers to the perceived alignment of the intervention within a particular practice setting and will be measured by the 4-item Intervention Appropriateness Measure (IAM). Scale values range from 1 to 5 with higher values indicating a better outcome.

  Up to 6 months

• Adoption

  Adoption refers to intentions or actions to adopt an EBI. Adoption will be measured as whether a HCP initiates buprenorphine prescribing for the first time or increases their patient panel (yes/no) and as the total number of patients receiving buprenorphine for each HCP.

  Up to 6 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Behavioral: Stigma-reduction training

Control

PLACEBO COMPARATOR

Behavioral: Placebo

Interventions

Stigma-reduction training BEHAVIORAL

While the details will be finalized by the intervention working group after the key modifiable features of OUD-stigma among rural HCPs are isolated in Aim 1, our intervention will include several new elements that distinguish it from existing stigma-reduction interventions. The prototype intervention includes several modules aimed at decreasing stigma, increasing knowledge about medications for OUD, and increasing willingness to prescribe buprenorphine (see Table 3) among rural HCPs currently in practice.

Intervention

Placebo BEHAVIORAL

HCPs affiliated with clinics in the control arm will receive no training but will be provided with a link to the SAMHSA website where prescribers can learn more about buprenorphine prescribing and apply to receive an X-waiver.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• physician, nurse practitioner, or physician assistant
• eligible to prescribe buprenorphine under federal law
• currently practices in primary care setting
• currently practices in rural-designated county
• at least 18 years of age

You may not qualify if:

• currently prescribing buprenorphine at full capacity

Sponsors & Collaborators

• Ohio University: lead
• Ohio State University: collaborator
• Rutgers University: collaborator
• University of North Carolina: collaborator

Study Sites (1)

Berkeley Franz

Athens, Ohio, 45701, United States

Location

Related Publications (1)

• Franz B, Dhanani LY, Hall OT, Brook DL, Fenstemaker C, Simon JE, Miller WC. Buprenorphine misinformation and willingness to treat patients with opioid use disorder among primary care-aligned health care professionals. Addict Sci Clin Pract. 2024 Jan 19;19(1):7. doi: 10.1186/s13722-024-00436-y.

  PMID: 38243307 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Social Stigma

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Social Behavior; Behavior

Study Officials

• Berkeley Franz, Ph.D.

  Ohio University Heritage College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 17, 2022
• Study Start: September 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)