Back to resultsEffectiveness of a CBT-based mHealth Intervention Targeting MOUD Retention, Adherence, and Opioid Use (UCimFREE)
Primary Purpose
Opioid-use Disorder
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
imFREE mCBT
mHealth ED
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder
Eligibility Criteria
Inclusion Criteria:
- Age > 18
- DSM-5 diagnosis of OUD
- no more than 2 weeks from the date of BUP induction
- able to read and comprehend English at the 6th grade level (determined by REALM)
- able to provide informed consent
- presently owns a mobile phone that can send and receive text messages
EXCLUSION CRITERIA
Participants must not have:
- Life threatening or unstable medical illness requiring treatment or making participation difficult
- Dependence on alcohol or other illicit substances for which medical detoxification is imminently needed
- Presence of acute psychiatric symptoms warranting intensive treatment or hospitalization (e.g., acute suicidality or mania).
Sites / Locations
- Tarzana Treatment Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
UC imFREE Smartphone application intervention
Health Education and pamphlet
Arm Description
The imFREE condition is a 32-week tailored, interactive text messaging intervention targeting buprenorphine treatment retention and adherence as well as opioid use and associated health consequences. Following a face-to-face CBT session with a clinician, participants receive CBT skills training via daily text messaging, with content themes around relapse prevention, adherence behaviors, and personalized plans to overcome risk factors for treatment discontinuation.
The mHealth condition will provide participants with a manualized health psychoeducation session of equivalent duration to the face-to-face CBT session delivered to imFREE participants. Content focuses on various dimensions of health and well-being. Subsequent to this session participants will receive an informational pamphlet regarding BUP and the importance of adherence. the mHealth component of the intervention comprises text reminders for scheduled MM appointments.
Outcomes
Primary Outcome Measures
Medication Adherence self-report form. Unannounced medication count by phone
Self-report of Treatment adherence to buprenorphine collected in self-report forms. Unannounced medication count by phone. Research staff will call participants and ask them to count out the remaining buprenorphine films left in their prescription.
Secondary Outcome Measures
DSM-V Checklist
Assessing the presence of opiate use disorder
Full Information
NCT ID
NCT04808479
First Posted
February 8, 2021
Last Updated
April 22, 2022
Sponsor
University of California, Los Angeles
Collaborators
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT04808479
Brief Title
Effectiveness of a CBT-based mHealth Intervention Targeting MOUD Retention, Adherence, and Opioid Use
Acronym
UCimFREE
Official Title
FOA Title: HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication-Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The focus of this study is to examine the effectiveness of imFREE relative to mHealth ED in facilitating treatment retention and adherence and reducing opioid use among adults with OUD initiating BUP treatment.
There are two specific aims: (1) to test the effectiveness of imFREE, delivered in conjunction with medical management with buprenorphine (imFREE + MM), relative to mHealth ED + MM, in facilitating buprenorphine treatment retention and adherence in a population of individuals with OUD initiating MM (N=200). (2) To evaluate the cost-effectiveness of imFREE.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UC imFREE Smartphone application intervention
Arm Type
Experimental
Arm Description
The imFREE condition is a 32-week tailored, interactive text messaging intervention targeting buprenorphine treatment retention and adherence as well as opioid use and associated health consequences. Following a face-to-face CBT session with a clinician, participants receive CBT skills training via daily text messaging, with content themes around relapse prevention, adherence behaviors, and personalized plans to overcome risk factors for treatment discontinuation.
Arm Title
Health Education and pamphlet
Arm Type
Active Comparator
Arm Description
The mHealth condition will provide participants with a manualized health psychoeducation session of equivalent duration to the face-to-face CBT session delivered to imFREE participants. Content focuses on various dimensions of health and well-being. Subsequent to this session participants will receive an informational pamphlet regarding BUP and the importance of adherence. the mHealth component of the intervention comprises text reminders for scheduled MM appointments.
Intervention Type
Behavioral
Intervention Name(s)
imFREE mCBT
Other Intervention Name(s)
imFREE
Intervention Description
The imFREE condition is a 32-week tailored, interactive text messaging intervention targeting buprenorphine treatment retention and adherence as well as opioid use and associated health consequences. Following a face-to-face CBT session with a clinician, participants receive CBT skills training via daily text messaging, with content themes around relapse prevention, adherence behaviors, and personalized plans to overcome risk factors for treatment discontinuation.
Intervention Type
Behavioral
Intervention Name(s)
mHealth ED
Other Intervention Name(s)
Manualized Health Psychoeducation
Intervention Description
The mHealth condition will provide participants with a manualized health psychoeducation session of equivalent duration to the face-to-face CBT session delivered to imFREE participants. Content focuses on various dimensions of health and well-being. Subsequent to this session participants will receive an informational pamphlet regarding BUP and the importance of adherence. the mHealth component of the intervention comprises text reminders for scheduled MM appointments.
Primary Outcome Measure Information:
Title
Medication Adherence self-report form. Unannounced medication count by phone
Description
Self-report of Treatment adherence to buprenorphine collected in self-report forms. Unannounced medication count by phone. Research staff will call participants and ask them to count out the remaining buprenorphine films left in their prescription.
Time Frame
Monthly from date of randomization, for up to 6 months, or until study completion, whichever comes first.
Secondary Outcome Measure Information:
Title
DSM-V Checklist
Description
Assessing the presence of opiate use disorder
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
European Addiction Severity Index
Description
The Addiction Severity Index is a relatively brief, semi-structured interview designed to provide important information about aspects of a client's life that may contribute to his/her substance abuse syndrome.Assessment of addiction severity and frequency of alcohol/drug use.
Time Frame
Baseline, month 3, month 6
Title
Urine drug screen
Description
Confirming absence/presence of opiates and buprenorphine
Time Frame
Throughout six months, monthly
Title
Medical Management (MM) attendance
Description
Retention in buprenorphine treatment my reviewing number of MM sessions attended
Time Frame
Throughout six months, monthly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18
DSM-5 diagnosis of OUD
no more than 2 weeks from the date of BUP induction
able to read and comprehend English at the 6th grade level (determined by REALM)
able to provide informed consent
presently owns a mobile phone that can send and receive text messages
EXCLUSION CRITERIA
Participants must not have:
Life threatening or unstable medical illness requiring treatment or making participation difficult
Dependence on alcohol or other illicit substances for which medical detoxification is imminently needed
Presence of acute psychiatric symptoms warranting intensive treatment or hospitalization (e.g., acute suicidality or mania).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzette Glasner, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tarzana Treatment Center
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of a CBT-based mHealth Intervention Targeting MOUD Retention, Adherence, and Opioid Use
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