Opioid-Related DisordersNCT05505227
Developing a Tailored Stigma Reduction Intervention to Increase Buprenorphine Prescribing
A study testing Stigma-reduction training in people with Opioid-Related Disorders and Buprenorphine, run by Ohio University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders, Buprenorphine, Social Stigma
- What is being tested?
- Stigma-reduction training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- currently prescribing buprenorphine at full capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Tailored Stigma Reduction Intervention to Increase Buprenorphine Prescribing Among Rural Primary Care Providers in Ohio
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.
- Being tested
- Stigma-reduction training, Placebo
- Medical subject headings
- Opioid-Related Disorders, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stigma-reduction trainingBehavioural
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.
PlaceboBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Not described Receives: Behavioral: Stigma-reduction training |
| Control | Placebo comparator | Not described Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Sep 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, Rutgers University, University of North Carolina
- Responsible party
- Sponsor
- Investigators
- Berkeley Franz, Ph.D., Principal investigator, Ohio University Heritage College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505227
- Sponsor's protocol ID
- 1R34DA057160
- Status last verified
- Apr 2025
- First submitted
- 12 Aug 2022
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Franz B, Dhanani LY, Brook D, Hall OT, Go V, Simon JE, Fenstemaker C, Miller WC. Brief Prescribing Support and Buprenorphine Adoption in Rural Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e263050. doi: 10.1001/jamanetworkopen.2026.3050.
PubMed 41879782Franz 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.
PubMed 38243307
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Tailored Stigma Reduction Intervention to Increase Buprenorphine Prescribing Among Rural Primary Care Providers in Ohio
- ClinicalTrials.gov ID
- NCT05505227
- Acronym / sponsor ID
- 1R34DA057160
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Collaborators
- Ohio State University, Rutgers University, University of North Carolina
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Stigma-reduction training |
| Control | Placebo comparator | Behavioral: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- currently prescribing buprenorphine at full capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stigma-reduction trainingWhile 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. | Behavioural | Intervention |
| PlaceboHCPs 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. | Behavioural | Control |
Primary outcome
Feasibility Intervention Measure
Time frame: Up to 6 months
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.
Acceptability
Time frame: Up to 6 months
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.
Appropriateness
Time frame: Up to 6 months
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.
Adoption
Time frame: Up to 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Derived from this study: PubMed 41879782Franz B, Dhanani LY, Brook D, Hall OT, Go V, Simon JE, Fenstemaker C, Miller WC. Brief Prescribing Support and Buprenorphine Adoption in Rural Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e263050. doi: 10.1001/jamanetworkopen.2026.3050.
- Derived from this study: PubMed 38243307Franz 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.
- Individual participant dataSharing planned: No
Related trials for Opioid-Related Disorders
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Active, not recruitingObservational study
Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
RecruitingObservational study
Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
Opioid-Related Disorders, Drug Addiction
RecruitingPhase 2
A Study of Cebranopadol for Opioid Withdrawal Symptoms in Adults With Chronic Pain
Chronic Pain, Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berkeley Franz, Ph.D. principal investigator
Ohio University Heritage College of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stigma-reduction training in people with Opioid-Related Disorders and Buprenorphine, run by Ohio University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Intervention Measure (time frame: Up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05505227, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.