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Active, not recruitingNCT05505227Updated May 29, 2025

Developing a Tailored Stigma Reduction Intervention to Increase Buprenorphine Prescribing

An interventional study of Stigma-reduction training and Placebo in Opioid-Related Disorders, Buprenorphine and Social Stigma, sponsored by Ohio University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-29.

Sponsored by Ohio University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Rural counties, particularly in Appalachia, are battling fast-growing outbreaks of HIV and have been labeled by the CDC as vulnerable to growing transmission rates due to widespread injection drug use. One of the most promising mechanisms for reducing HIV transmission in these communities is the use of buprenorphine, which treats opioid use disorder and also reduces behaviors that increase HIV risk. Despite the potential benefit of buprenorphine, health care professionals (HCPs) in rural areas of the United States are much less likely to have received the training and federal waiver necessary to prescribe this medication. Stigma toward patients who use drugs is an accepted barrier to substance use treatment, but it also impacts health care professionals, especially rural primary care prescribers such as physicians, nurse practitioners, and physicians assistants who are on the front lines of the opioid crisis. The investigators have shown in previous studies that stigma is a primary reason why fewer rural health care professionals are willing to work with patients with OUD. Stigma and negative attitudes toward patients with OUD, fortunately, are modifiable but require training interventions that are both effective and feasible to implement in rural practice settings. Previous interventions have been used with health care professionals successfully to reduce stigma, but they have not been tailored for medications for opioid use, such as buprenorphine, or for the rural primary care setting. The study team proposes to adapt an existing brief stigma-reduction training intervention to the rural primary care setting to increase buprenorphine prescribing and implement a randomized, pilot study to assess feasibility and acceptability among rural primary care providers. Our specific aims are to: 1) Examine HCP knowledge and attitudes about OUD to understand their reluctance to prescribe MOUD and manage patients with OUD. 2) Develop a prototype narrative-based stigma reduction intervention and tailor it to the rural primary care setting using HCP feedback and 3) Assess the feasibility and acceptability of a stigma-reduction intervention in a pilot study in a diverse group of rural HCPs across 6 primary care clinics. The primary pilot trial outcomes are feasibility, acceptability, appropriateness, and adoption, measured among a cohort of HCPs who do not currently prescribe buprenorphine at full capacity. The investigators will also measure additional stigma outcomes such as attitudes towards patients with OUD and harm reduction. The invesstigators will use in-depth interviews to further assess perceptions of the intervention and finalize it for use in a follow-up cluster randomized controlled trial. This developmental trial will produce a brief stigma reduction training intervention that is acceptable and feasible to implement in rural primary care clinics. The long-term goal is to establish a brief stigma-reduction training intervention that is modifiable for different practice settings and effective at increasing buprenorphine prescribing in underserved communities.

02

Conditions studied

  • Opioid-Related Disorders
  • Buprenorphine
  • Social Stigma
  • Rural Health Services
03

In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's planned enrollment of 400 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

Ohio University is the lead sponsor of 64 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • currently prescribing buprenorphine at full capacity
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
400 participants (estimated)

Study arms

  • Active comparator
    Intervention

    Behavioral: Stigma-reduction training

  • Placebo comparator
    Control

    Behavioral: Placebo

Interventions

  • BehavioralStigma-reduction training

    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.

  • BehavioralPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 6 months

  2. 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.

    Time frame: Up to 6 months

  3. 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.

    Time frame: Up to 6 months

  4. 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.

    Time frame: Up to 6 months

07

Study locations

1 site
  • Berkeley Franz
    Athens, Ohio 45701, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05505227
Lead sponsor
Ohio University
Collaborators
Ohio State University, Rutgers University, University of North Carolina
Responsible party
Sponsor
First posted
Aug 17, 2022
Start date
Sep 1, 2022
Primary completion
Jun 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
May 29, 2025

Study contacts

Berkeley Franz, Ph.D.
principal investigator · Ohio University Heritage College of Osteopathic Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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