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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imFREE mCBT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Monthly from date of randomization, for up to 6 months, or until study completion, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| DSM-V Checklist | Assessing the presence of opiate use disorder | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| European Addiction Severity Index | 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. | Baseline, month 3, month 6 |
Inclusion Criteria:
EXCLUSION CRITERIA
Participants must not have:
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| Name | Affiliation | Role |
|---|---|---|
| Suzette Glasner, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tarzana Treatment Center | Tarzana | California | 91356 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| mHealth ED | Behavioral | 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. |
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| Urine drug screen |
Confirming absence/presence of opiates and buprenorphine |
| Throughout six months, monthly |
| Medical Management (MM) attendance | Retention in buprenorphine treatment my reviewing number of MM sessions attended | Throughout six months, monthly |