## Protocol Section
### Identification Module
**NCT ID:** NCT04808479

**Acronym:** UCimFREE

**Brief Title:** Effectiveness of a CBT-based mHealth Intervention Targeting MOUD Retention, Adherence, and Opioid Use

**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

#### Organization Study ID Info
**ID:** UC imFREE phase1&RCT
#### Organization
**Class:** OTHER
**Full Name:** University of California, Los Angeles
### Status Module
#### Completion Date
**Date:** 2026-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2025-08-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-12-10

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2021-03-22
**Type:** ACTUAL
**Study First Submit Date:** 2021-02-08
**Study First Submit QC Date:** 2021-03-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of California, San Diego

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, Los Angeles

#### Responsible Party

**Investigator Affiliation:** University of California, Los Angeles

**Investigator Full Name:** Suzette Glasner-Edwards

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Opioid-use Disorder

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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 Names:**

- Behavioral: imFREE mCBT

**Label:** UC imFREE Smartphone application intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**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 Names:**

- Behavioral: mHealth ED

**Label:** Health Education and pamphlet

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- UC imFREE Smartphone application 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.

**Name:** imFREE mCBT

**Other Names:**

- imFREE

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Health Education and pamphlet

**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.

**Name:** mHealth ED

**Other Names:**

- Manualized Health Psychoeducation

**Type:** BEHAVIORAL

### Outcomes Module

#### Other Outcomes

**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.

**Measure:** European Addiction Severity Index

**Time Frame:** Baseline, month 3, month 6

**Description:** Confirming absence/presence of opiates and buprenorphine

**Measure:** Urine drug screen

**Time Frame:** Throughout six months, monthly

**Description:** Retention in buprenorphine treatment my reviewing number of MM sessions attended

**Measure:** Medical Management (MM) attendance

**Time Frame:** Throughout six months, monthly

#### Primary Outcomes

**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.

**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.

#### Secondary Outcomes

**Description:** Assessing the presence of opiate use disorder

**Measure:** DSM-V Checklist

**Time Frame:** Baseline

### Eligibility Module

**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:

1. Life threatening or unstable medical illness requiring treatment or making participation difficult
2. Dependence on alcohol or other illicit substances for which medical detoxification is imminently needed
3. Presence of acute psychiatric symptoms warranting intensive treatment or hospitalization (e.g., acute suicidality or mania).

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tarzana

**Country:** United States

**Facility:** Tarzana Treatment Center

**State:** California

**Zip:** 91356

#### Overall Officials

**Official 1:**

**Affiliation:** University of California, Los Angeles

**Name:** Suzette Glasner, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000079524

- Term: Narcotic-Related Disorders

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12244

- Name: Opioid-Related Disorders

- Relevance: HIGH

- As Found: Opioid Use Disorder

- ID: M2057

- Name: Narcotic-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009293

- Term: Opioid-Related Disorders

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: NarcAntag

- Name: Narcotic Antagonists

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M5317

- Name: Buprenorphine

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
