Opioid Use DisorderPhase 1OASISNCT06266572
Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment
A Phase 1 study testing Overcoming and Addressing Stigma in Substance Use Disorders (OASIS) in people with Opioid Use Disorder, run by Center for Social Innovation, Massachusetts at 1 site in United States.
Trial summary
C4 Innovations (C4) and partners at Yale University (Yale) and the West Haven VA Medical Center (WHVA) proposed to develop and test OASIS (Overcoming and Addressing Stigma in Substance Use Disorders), a web-based educational platform for primary care clinicians and individuals with Opioid Use Disorder. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Overcoming and Addressing Stigma in Substance Use Disorders (OASIS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2021to 29 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- For providers:
- Clinically active and seeing patients;
- Having a device with Internet access to use the OASIS prototype
- English speaking
- Willing and able to complete data collection activities.
- For patients:
Show all 12Show fewer
- Diagnosed OUD
- Unmet substance use treatment need
- Has an upcoming primary care visit scheduled for the intervention period (1-2 months)
- English speaking
- Has access to a device with Internet access to use the OASIS prototype
- Willing and able to complete data collection activities
Who cannot join
- Patient participants will be excluded from this study if they:
- 1) Currently receiving or have received medication for opioid dependence.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Haven VA Medical Center
West Haven, Connecticut, 06516
About this study
Official title: Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement,
C4 Innovations (C4) and partners at Yale University (Yale) and the West Haven VA Medical Center (WHVA) proposed to develop and test OASIS (Overcoming and Addressing Stigma in Substance Use Disorders), a web-based educational platform for primary care clinicians and individuals with Opioid Use Disorder. The major aims of the study were to:
- Develop a prototype of OASIS for patients with Opioid Use Disorder (OUD) and primary care clinicians; conduct usability testing.
- Pilot OASIS with a small sample of individuals with untreated OUD and their clinicians to determine feasibility, acceptability, and preliminary product effectiveness for a Phase II effectiveness trial.
After development of the prototype, the C4-Yale-WHVA team planned to test OASIS with patients (N = 30) and clinicians (N = 5) using validated measures and qualitative interviews to assess usability, satisfaction, knowledge, empowerment, and stigma.
- Conditions
- Opioid Use Disorder
- Being tested
- Overcoming and Addressing Stigma in Substance Use Disorders (OASIS)
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overcoming and Addressing Stigma in Substance Use Disorders (OASIS)Behavioural
Web-based educational platform for clinicians and individuals with OUD that will decrease barriers to care and enhance treatment outcomes
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention | Experimental | Research participants will receive access to a web-based platform designed to provide information about Opioid Use Disorder. Prior to receiving access to this application, research participants will complete online, self-reported surveys assessing stigma, empowerment, and knowledge of opioids. Receives: Behavioral: Overcoming and Addressing Stigma in Substance Use Disorders (OASIS) |
| Post-Intervention | Experimental | Research participants will have access to the web-based platform for 7 to 14 days prior to receiving a second, identical series of self-report surveys assessing stigma, empowerment, and knowledge of opioids. Additionally, after using the platform, research participants will complete a measure of system usability. Receives: Behavioral: Overcoming and Addressing Stigma in Substance Use Disorders (OASIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Open Minds Scale for Health Care Providers
Description: A 20-item scale assessing stigma in health care providers, rated on a 5 point likert scale from Strongly Disagree (1) to Strongly Agree (5).
Measured: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
Brief Opioid Stigma Scale
An 8-item scale assessing perceptions of stigma and endorsed stigma toward individuals using opioids. Rated on a 5 point likert scale from Strongly Disagree (1) to Strongly Agree (5). Providers in this study did not complete the items on the Harm subscale, items 9-12.
Measured: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
Perceived Stigma of Addiction Scale
An 8-item scale assessing perceptions of stigma towards individuals with substance use disorders. Rated on a 7 point likert scale from Very Strongly Disagree (1) to Very Strongly Agree (7).
Measured: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
Knowledge Check
A 10-item assessment developed by the research team to assess knowledge of opioids and opioid use disorder
Measured: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week
System Usability Scale
A 10-item measure assessing the overall usability of the online platform. Rated on a 5 point likert scale from Strongly Disagree (1) to Strongly Agree (5).
Measured: Assess only at the post-assessment, after using the platform for at least one week.
Internalized Stigma of Mental Illness Scale
A 29-item measure assessing the participant's own stigma relating to mental illness. Rated on a 4 point likert scale from Strongly Disagree (1) to Strongly Agree (4).
Measured: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
Recovery Empowerment Scale
A 20-item scale assessing a participant's levels of empowerment, rated on a 7 point likert scale from Almost Never (1) to Almost Always (7).
Measured: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
Mental Health Seeking Attitudes Scale
A 9-item scale assessing the individuals rating between two dichotomous choices and how accurately they describe their perceptions of help-seeking. Participants are asked to choose one of two words on a scale (e.g., useless vs. useful) and are asked to rate how strongly they feel this word describes their thoughts on a scale from Undecided (0) to Extremely (3).
Measured: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start30 Sep 2021
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies 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 1
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Social Innovation, Massachusetts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266572
- Sponsor's protocol ID
- 1R43DA055182-01
- Acronym
- OASIS
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement,
- ClinicalTrials.gov ID
- NCT06266572
- Acronym / sponsor ID
- OASIS / 1R43DA055182-01
- Conditions
- Opioid Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Center for Social Innovation, MassachusettsUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 20 Feb 2024 (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.
C4 Innovations (C4) and partners at Yale University (Yale) and the West Haven VA Medical Center (WHVA) proposed to develop and test OASIS (Overcoming and Addressing Stigma in Substance Use Disorders), a web-based educational platform for primary care clinicians and individuals with Opioid Use Disorder. The major aims of the study were to:
- Develop a prototype of OASIS for patients with Opioid Use Disorder (OUD) and primary care clinicians; conduct usability testing.
- Pilot OASIS with a small sample of individuals with untreated OUD and their clinicians to determine feasibility, acceptability, and preliminary product effectiveness for a Phase II effectiveness trial.
After development of the prototype, the C4-Yale-WHVA team planned to test OASIS with patients (N = 30) and clinicians (N = 5) using validated measures and qualitative interviews to assess usability, satisfaction, knowledge, empowerment, and stigma.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention | Experimental | Behavioral: Overcoming and Addressing Stigma in Substance Use Disorders (OASIS)Research participants will receive access to a web-based platform designed to provide information about Opioid Use Disorder. Prior to receiving access to this application, research participants will complete online, self-reported surveys assessing stigma, empowerment, and knowledge of opioids. |
| Post-Intervention | Experimental | Behavioral: Overcoming and Addressing Stigma in Substance Use Disorders (OASIS)Research participants will have access to the web-based platform for 7 to 14 days prior to receiving a second, identical series of self-report surveys assessing stigma, empowerment, and knowledge of opioids. Additionally, after using the platform, research participants will complete a measure of system usability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Clinically active and seeing patients;
- Having a device with Internet access to use the OASIS prototype
- English speaking
- Willing and able to complete data collection activities.
- Diagnosed OUD
Key exclusion criteria (2 listed)
- 1) Currently receiving or have received medication for opioid dependence.
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 |
|---|---|---|
| Overcoming and Addressing Stigma in Substance Use Disorders (OASIS)Web-based educational platform for clinicians and individuals with OUD that will decrease barriers to care and enhance treatment outcomes | Behavioural | Post-Intervention, Pre-Intervention |
Primary outcome
Open Minds Scale for Health Care Providers
Time frame: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
Description: A 20-item scale assessing stigma in health care providers, rated on a 5 point likert scale from Strongly Disagree (1) to Strongly Agree (5).
Brief Opioid Stigma Scale
Time frame: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
An 8-item scale assessing perceptions of stigma and endorsed stigma toward individuals using opioids. Rated on a 5 point likert scale from Strongly Disagree (1) to Strongly Agree (5). Providers in this study did not complete the items on the Harm subscale, items 9-12.
Perceived Stigma of Addiction Scale
Time frame: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
An 8-item scale assessing perceptions of stigma towards individuals with substance use disorders. Rated on a 7 point likert scale from Very Strongly Disagree (1) to Very Strongly Agree (7).
Knowledge Check
Time frame: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week
A 10-item assessment developed by the research team to assess knowledge of opioids and opioid use disorder
System Usability Scale
Time frame: Assess only at the post-assessment, after using the platform for at least one week.
A 10-item measure assessing the overall usability of the online platform. Rated on a 5 point likert scale from Strongly Disagree (1) to Strongly Agree (5).
Internalized Stigma of Mental Illness Scale
Time frame: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
A 29-item measure assessing the participant's own stigma relating to mental illness. Rated on a 4 point likert scale from Strongly Disagree (1) to Strongly Agree (4).
Recovery Empowerment Scale
Time frame: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
A 20-item scale assessing a participant's levels of empowerment, rated on a 7 point likert scale from Almost Never (1) to Almost Always (7).
Mental Health Seeking Attitudes Scale
Time frame: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.
A 9-item scale assessing the individuals rating between two dichotomous choices and how accurately they describe their perceptions of help-seeking. Participants are asked to choose one of two words on a scale (e.g., useless vs. useful) and are asked to rate how strongly they feel this word describes their thoughts on a scale from Undecided (0) to Extremely (3).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Overcoming and Addressing Stigma in Substance Use Disorders (OASIS) in people with Opioid Use Disorder, run by Center for Social Innovation, Massachusetts 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 12 inclusion and 2 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: finished, as of the sponsor's last update on 1 Mar 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Open Minds Scale for Health Care Providers (time frame: Assessed at both timepoints: prior to accessing the online platform and after using the platform for at least one week.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2024.