- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03151655
Changing Opioid Users' Negative Attitudes Toward Medication Assisted Treatment
June 1, 2022 updated by: Brandon Gaudiano, Butler Hospital
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 Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02916
- Butler Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MATTeRS Video
|
Narrative-based video intervention and accompanying workbook
|
Active Comparator: Didactic Video
|
Education only video
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initiation of Medication Assisted Treatment
Time Frame: 1 Month Post-Discharge
|
Whether or not patients started medication-assisted treatment during the assessment period.
|
1 Month Post-Discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2019
Primary Completion (Anticipated)
January 1, 2022
Study Completion (Anticipated)
January 1, 2022
Study Registration Dates
First Submitted
October 14, 2016
First Submitted That Met QC Criteria
May 11, 2017
First Posted (Actual)
May 12, 2017
Study Record Updates
Last Update Posted (Actual)
June 2, 2022
Last Update Submitted That Met QC Criteria
June 1, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1610-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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