Opioid Use DisorderNCT03151655
Changing Opioid Users' Negative Attitudes Toward Medication Assisted Treatment
A study testing MATTeRS Video and Didactic Video in people with Opioid Use Disorder, run by Butler Hospital at 1 site in United States.
Trial summary
In this treatment development project, the investigators propose to develop and assess the feasibility and acceptability of a narrative-based video intervention and accompanying workbook (entitled MATTeRS: Medication Assisted Treatments: Telling Real Stories) designed to be used by people in inpatient opioid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- MATTeRS Video and Didactic Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 1 Jan 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently undergoing inpatient opioid detoxification;
- Qualify for use of one or more MATs;
- Have health insurance;
- Able to read and speak English;
- Aged 18 or older;
- No suicide ideation or behavior requiring immediate attention;
Show all 9Show fewer
- Live in the Rhode Island or Massachusetts area and have a working telephone;
- Able to provide two contact persons to verify location and in case we are unable to reach the participant during the study;
- Do not have probation/parole requirements that might interfere with protocol participation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
In this treatment development project, the investigators propose to develop and assess the feasibility and acceptability of a narrative-based video intervention and accompanying workbook (entitled MATTeRS: Medication Assisted Treatments: Telling Real Stories) designed to be used by people in inpatient opioid detoxification. Using the Health Belief Model as a framework, videos will provide information about the uses and outcomes of Medication Assisted Treatments (MATs) compared to other or no post-detoxification treatment through the use of narratives from real people's lives.
- Conditions
- Opioid Use Disorder
- Being tested
- MATTeRS Video, Didactic Video
- 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.
MATTeRS VideoBehavioural
Narrative-based video intervention and accompanying workbook
Didactic VideoBehavioural
Education only video
| Study group | Role | What they receive |
|---|---|---|
| MATTeRS Video | Experimental | Not described Receives: Behavioral: MATTeRS Video |
| Didactic Video | Active comparator | Not described Receives: Behavioral: Didactic Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of Medication Assisted Treatment
Whether or not patients started medication-assisted treatment during the assessment period.
Measured: 1 Month Post-Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start1 Jan 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2022 (estimated)
Why it stopped: Funding was not secured for the project as expected, so we were unable to proceed with the project.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandon Gaudiano, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151655
- Sponsor's protocol ID
- 1610-001
- Status last verified
- Nov 2024
- First submitted
- 14 Oct 2016
- Last updated
- 6 Nov 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 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Opioid Users' Negative Attitudes Toward Medication Assisted Treatment
- ClinicalTrials.gov ID
- NCT03151655
- Acronym / sponsor ID
- 1610-001
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was not secured for the project as expected, so we were unable to proceed with the project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 12 May 2017 (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.
In this treatment development project, the investigators propose to develop and assess the feasibility and acceptability of a narrative-based video intervention and accompanying workbook (entitled MATTeRS: Medication Assisted Treatments: Telling Real Stories) designed to be used by people in inpatient opioid detoxification. Using the Health Belief Model as a framework, videos will provide information about the uses and outcomes of Medication Assisted Treatments (MATs) compared to other or no post-detoxification treatment through the use of narratives from real people's lives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MATTeRS Video | Experimental | Behavioral: MATTeRS Video |
| Didactic Video | Active comparator | Behavioral: Didactic Video |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Currently undergoing inpatient opioid detoxification;
- Qualify for use of one or more MATs;
- Have health insurance;
- Able to read and speak English;
- Aged 18 or older;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MATTeRS VideoNarrative-based video intervention and accompanying workbook | Behavioural | MATTeRS Video |
| Didactic VideoEducation only video | Behavioural | Didactic Video |
Primary outcome
Initiation of Medication Assisted Treatment
Time frame: 1 Month Post-Discharge
Whether or not patients started medication-assisted treatment during the assessment period.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 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 study testing MATTeRS Video and Didactic Video in people with Opioid Use Disorder, run by Butler Hospital 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 9 inclusion and 0 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: withdrawn, as of the sponsor's last update on 6 Nov 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Initiation of Medication Assisted Treatment (time frame: 1 Month Post-Discharge). 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 6 Nov 2024.