Impact on Opioid Use of Bundling Medication-assisted Treatment With mHealth

Study Overview
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Brief Summary
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The primary aim of this study is to measure and explain the impact on long-term opioid use when medication-assisted treatment (MAT) is bundled with an evidence-based mobile-health system (A-CHESS).

Official Title
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Impact on Opioid Use of Bundling Medication-assisted Treatment With mHealth

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Behavioral: MAT + A-CHESS
* Other: MAT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are 18+ years old; meet criteria for opioid use disorders of at least moderate severity (4 or 5 DSM-V criteria); Are currently taking medication-assisted treatment (MAT) as part of their standard clinical care; have no acute medical problem requiring immediate inpatient treatment; have no history of psychotic disorders, though those with other co-morbid psychopathology (mood disorders, anxiety, other substance use disorders) will be eligible; are willing to participate in a randomized clinical trial; provide the name, verified telephone number, and address of at least 2 contacts willing to help locate the patient, if necessary, during follow-up; are able to read and write in English; are not pregnant; are willing to share health-related data with primary care clinicians; and are, at study intake, abstinent from opioids for at least 1 week and no longer than 2 months, except for medications used to treat the disorder (e.g., methadone).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Medication-assisted treatment (MAT)<br>Patients will receive standard medication-assisted treatment (MAT) as prescribed by their health care provider. | Other: MAT<br>* Patients will receive treatment consisting of a recovery plan, appropriate pharmacology, routine urine screens, and regularly scheduled behavioral interventions, such as monthly group counseling sessions or sessions with a recovery coach. Appropriate pharmacology may include methadone; naltrexone; buprenorphine; and in the case of overdose, naloxone; and other medications and combinations of medications as part of the patient's standard clinical care.<br>|
| Experimental: MAT + A-CHESS<br>Patients in the MAT + A-CHESS arm will receive MAT as described plus the A-CHESS recovery support system via a smartphone. | Behavioral: MAT + A-CHESS<br>* Subjects randomized to MAT + A-CHESS will receive MAT plus the A-CHESS recovery support system which provides: Self-directed, interactive modules that teach basic recovery support, harm-reduction, and psychosocial functioning skills. The latest information about addiction and recovery support, monitoring prompts, and peer and family support. Advice on where to go for help and on how to make the best use of health and human services; and A way to talk with experts in the area of addiction and other study participants by sending anonymous messages in the A-CHESS discussion groups. A way to keep your health care team up to date through reports based on information entered into A-CHESS (i.e. alcohol and drug use, depression, MAT side effects).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use | Detect the difference in illicit opioid use between patients who have MAT + A-CHESS vs. MAT alone. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication-assisted treatment (MAT), Buprenorphine, Methadone, Naltrexone