Opioid Use Disorder Clinical Trial
— PtDA-MATOfficial title:
Pilot Test of Patient Decision Aid for Medication-Assisted Treatment for Opioid Use Disorder
NCT number | NCT03394261 |
Other study ID # | OPIOD1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 14, 2018 |
Est. completion date | December 21, 2018 |
Verified date | November 2020 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | December 21, 2018 |
Est. primary completion date | December 21, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Opioid Use Disorder diagnosis and agreement to follow study procedures (including permission to share medical records and other administrative records) Exclusion Criteria: - Significant or unstable medical or psychiatric illness that may interfere with study participation |
Country | Name | City | State |
---|---|---|---|
United States | Tarzana Treatment Centers, Inc. | Tarzana | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 3 months | |
Secondary | 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) | 3 month | |
Secondary | Treatment Adherence | Treatment Adherence defined as proportion of clinic visits attended | 3 month |
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