Opioid Use DisorderPtDA-MATNCT03394261
Pilot Test of Patient Decision Aid for Opioid Use Disorder
A study testing Patient Decision Aid in people with Opioid Use Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The aims of the current study phase (R21) are: Aim 1. Develop a patient decision aid (PtDA-MAT) by incorporating best available scientific evidence on MAT as well as feedback from patients and clinical providers related to clinical priorities, perceived utility, and acceptability; Aim 2. 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?
- Patient Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2018to 21 Dec 2018
- 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
- Opioid Use Disorder diagnosis and agreement to follow study procedures (including permission to share medical records and other administrative records)
Who cannot join
- Significant or unstable medical or psychiatric illness that may interfere with study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Tarzana Treatment Centers, Inc.
Tarzana, California, 91356
About this study
Official title: Pilot Test of Patient Decision Aid for Medication-Assisted Treatment for Opioid Use Disorder
The aims of the current study phase (R21) are: Aim 1. Develop a patient decision aid (PtDA-MAT) by incorporating best available scientific evidence on MAT as well as feedback from patients and clinical providers related to clinical priorities, perceived utility, and acceptability; Aim 2. Conduct pilot testing of the PtDA-MAT in an iterative process guided by an expert panel and involving key stakeholders (e.g., patients, physicians, policymakers) and field-testing.
Read the detailed description
In response to RFA-DA-18-005 (Expanding Medication Assisted Treatment for Opioid Use Disorders in the Context of the SAMHSA Opioid STR Grants, R21/R33), this project will develop and test a patient decision support tool called Patient Decision Aid for Medication-Assisted Treatment (PtDA-MAT) for use in the CA H\&SS. The PtDA-MAT is designed to (1) improve patient knowledge and involvement and to subsequently improve treatment adherence and outcomes and (2) to support clinicians in informing and communicating with their patients with OUD along a continuum of care. The project will conduct 1 year of R21 to develop and pilot-test the PtDA-MAT to facilitate shared decision making in CA H\&SS, followed by 3 years of R33 to assess the effectiveness of the PtDA-MAT in a randomized controlled trial.
The aims of the current study phase (R21) are: Aim 1. Develop a patient decision aid (PtDA-MAT) by incorporating best available scientific evidence on MAT as well as feedback from patients and clinical providers related to clinical priorities, perceived utility, and acceptability; Aim 2. Conduct pilot testing of the PtDA-MAT in an iterative process guided by an expert panel and involving key stakeholders (e.g., patients, physicians, policymakers) and field-testing.
- Conditions
- Opioid Use Disorder
- Being tested
- Patient Decision Aid
- Keywords
- Opioid Use Disorder (OUD), Medication Assisted Therapy (MAT), Patient Decision Aid
- 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.
Patient Decision AidBehavioural
PtDA-MAT will provide information on MAT treatment options and pros and cons of each treatment option, and will assess patients' preferred options.
| Study group | Role | What they receive |
|---|---|---|
| Patient Decision Aid | Experimental | Patients in this arm will receive Patient Decision Aid for Medication Assisted Treatment for opioid use disorder. Receives: Behavioral: Patient Decision Aid |
| Record-only control group | No intervention | Treatment records of patients receiving treatment in the same clinic in the prior 3 months will be abstracted for comparison purposes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Retention
Treatment retention will be defined as number of days from initial treatment admission to either MAT discontinuation or most recent clinic visit followed by 2 months gap in treatment
Measured: 3 months
Secondary outcomes (2)
Drug screening results
Primarily opioid-negative urine testing (as collected by clinics as part of routine care) and other substance use per self-report (e.g., cannabis, benzodiazepines, cocaine, amphetamines)
Measured: 3 month
Treatment Adherence
Treatment Adherence defined as proportion of clinic visits attended
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start14 Jun 2018
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The Patient Decision Aid for Medication Assisted Therapy (PtDA-MAT) will be pilot-tested by patients and clinicians during actual visits with OUD patients to assess its acceptability and feasibility. We will track patients receiving PtDAT-MAT using their clinical and administration data over a 3-month period and compare outcomes to those of treatment admissions during the 3 months prior to the pilot testing to assess preliminary outcomes associated with PtDAT-MAT.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yih-Ing Hser, University of California, Los Angeles
- Investigators
- Yih-Ing Hser, Ph.D., Principal investigator, University of California, Los AngelesLarissa Mooney, M.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394261
- Sponsor's protocol ID
- OPIOD1
- Acronym
- PtDA-MAT
- Status last verified
- Nov 2020
- First submitted
- 3 Jan 2018
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mooney LJ, Valdez J, Cousins SJ, Yoo C, Zhu Y, Hser YI. Patient decision aid for medication treatment for opioid use disorder (PtDA-MOUD): Rationale, methodology, and preliminary results. J Subst Abuse Treat. 2020 Jan;108:115-122. doi: 10.1016/j.jsat.2019.08.006. Epub 2019 Oct 24.
PubMed 31668516
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of Patient Decision Aid for Medication-Assisted Treatment for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT03394261
- Acronym / sponsor ID
- PtDA-MAT / OPIOD1
- Conditions
- Opioid Use Disorder
- Keywords
- Opioid Use Disorder (OUD), Medication Assisted Therapy (MAT), Patient Decision Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 9 Jan 2018 (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.
The aims of the current study phase (R21) are: Aim 1. Develop a patient decision aid (PtDA-MAT) by incorporating best available scientific evidence on MAT as well as feedback from patients and clinical providers related to clinical priorities, perceived utility, and acceptability; Aim 2. Conduct pilot testing of the PtDA-MAT in an iterative process guided by an expert panel and involving key stakeholders (e.g., patients, physicians, policymakers) and field-testing.
Detailed description
In response to RFA-DA-18-005 (Expanding Medication Assisted Treatment for Opioid Use Disorders in the Context of the SAMHSA Opioid STR Grants, R21/R33), this project will develop and test a patient decision support tool called Patient Decision Aid for Medication-Assisted Treatment (PtDA-MAT) for use in the CA H\&SS. The PtDA-MAT is designed to (1) improve patient knowledge and involvement and to subsequently improve treatment adherence and outcomes and (2) to support clinicians in informing and communicating with their patients with OUD along a continuum of care. The project will conduct 1 year of R21 to develop and pilot-test the PtDA-MAT to facilitate shared decision making in CA H\&SS, followed by 3 years of R33 to assess the effectiveness of the PtDA-MAT in a randomized controlled trial.
The aims of the current study phase (R21) are: Aim 1. Develop a patient decision aid (PtDA-MAT) by incorporating best available scientific evidence on MAT as well as feedback from patients and clinical providers related to clinical priorities, perceived utility, and acceptability; Aim 2. Conduct pilot testing of the PtDA-MAT in an iterative process guided by an expert panel and involving key stakeholders (e.g., patients, physicians, policymakers) and field-testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Patient Decision Aid for Medication Assisted Therapy (PtDA-MAT) will be pilot-tested by patients and clinicians during actual visits with OUD patients to assess its acceptability and feasibility. We will track patients receiving PtDAT-MAT using their clinical and administration data over a 3-month period and compare outcomes to those of treatment admissions during the 3 months prior to the pilot testing to assess preliminary outcomes associated with PtDAT-MAT.
| Arm | Type | Receives |
|---|---|---|
| Patient Decision Aid | Experimental | Behavioral: Patient Decision AidPatients in this arm will receive Patient Decision Aid for Medication Assisted Treatment for opioid use disorder. |
| Record-only control group | No intervention | –Treatment records of patients receiving treatment in the same clinic in the prior 3 months will be abstracted for comparison purposes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Opioid Use Disorder diagnosis and agreement to follow study procedures (including permission to share medical records and other administrative records)
Key exclusion criteria (1 listed)
- Significant or unstable medical or psychiatric illness that may interfere with study participation
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 |
|---|---|---|
| Patient Decision AidPtDA-MAT will provide information on MAT treatment options and pros and cons of each treatment option, and will assess patients' preferred options. | Behavioural | Patient Decision Aid |
Primary outcome
Treatment Retention
Time frame: 3 months
Treatment retention will be defined as number of days from initial treatment admission to either MAT discontinuation or most recent clinic visit followed by 2 months gap in treatment
2 secondary outcomes
Drug screening results
Time frame: 3 month
Treatment Adherence
Time frame: 3 month
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 6 Nov 2026.
- Derived from this study: PubMed 31668516Mooney LJ, Valdez J, Cousins SJ, Yoo C, Zhu Y, Hser YI. Patient decision aid for medication treatment for opioid use disorder (PtDA-MOUD): Rationale, methodology, and preliminary results. J Subst Abuse Treat. 2020 Jan;108:115-122. doi: 10.1016/j.jsat.2019.08.006. Epub 2019 Oct 24.
- Individual participant dataSharing planned: Undecided
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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.
Yih-Ing Hser, Ph.D. principal investigator
University of California, Los Angeles
Larissa Mooney, M.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Decision Aid in people with Opioid Use Disorder, run by University of California, Los Angeles 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 1 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: finished, as of the sponsor's last update on 6 Nov 2026. 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 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?
Treatment Retention (time frame: 3 months). 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 NCT03394261, which also lists 1 linked publication.
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 2026.