Opioid-use DisorderUCimFREENCT04808479
Effectiveness of a CBT-based mHealth Intervention Targeting MOUD Retention, Adherence, and Opioid Use
A study testing imFREE mCBT and mHealth ED in people with Opioid-use Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial 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. 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?
- imFREE mCBT and mHealth ED
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2019to 15 Jun 2026
- 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
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Opioid-use Disorder
- Being tested
- imFREE mCBT, mHealth ED
- 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.
imFREE mCBTBehavioural
Also called imFREE
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.
mHealth EDBehavioural
Also called Manualized Health Psychoeducation
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.
| Study group | Role | What they receive |
|---|---|---|
| UC imFREE Smartphone application intervention | Experimental | 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. Receives: Behavioral: imFREE mCBT |
| Health Education and pamphlet | Active comparator | 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. Receives: Behavioral: mHealth ED |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Monthly from date of randomization, for up to 6 months, or until study completion, whichever comes first.
Secondary outcomes (1)
DSM-V Checklist
Assessing the presence of opiate use disorder
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start10 Dec 2019
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Suzette Glasner-Edwards, University of California, Los Angeles
- Investigators
- Suzette Glasner, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808479
- Sponsor's protocol ID
- UC imFREE phase1&RCT
- Acronym
- UCimFREE
- Status last verified
- Jul 2026
- First submitted
- 8 Feb 2021
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04808479
- Acronym / sponsor ID
- UCimFREE / UC imFREE phase1&RCT
- Conditions
- Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 22 Mar 2021 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC imFREE Smartphone application intervention | Experimental | Behavioral: imFREE mCBTThe 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. |
| Health Education and pamphlet | Active comparator | Behavioral: mHealth EDThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| imFREE mCBTAlso: imFREEThe 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. | Behavioural | UC imFREE Smartphone application intervention |
| mHealth EDAlso: Manualized Health PsychoeducationThe 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. | Behavioural | Health Education and pamphlet |
Primary outcome
Medication Adherence self-report form. Unannounced medication count by phone
Time frame: Monthly from date of randomization, for up to 6 months, or until study completion, whichever comes first.
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.
1 secondary outcome
DSM-V Checklist
Time frame: Baseline
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 7 Jul 2026.
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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.
Suzette Glasner, PhD 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 imFREE mCBT and mHealth ED 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 6 inclusion and 4 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 7 Jul 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?
Medication Adherence self-report form. Unannounced medication count by phone (time frame: Monthly from date of randomization, for up to 6 months, or until study completion, whichever comes first.). 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 7 Jul 2026.