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

University of Wisconsin (UW)

Status: Completed

Conditions: Opioid Use Disorder

Treatments: Behavioral: MAT + A-CHESS; Other: MAT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02712034

2015-1418

A195010 (Other Identifier)

INDUSTRIAL ENGR\CHESS PROG (Other Identifier)

1R01DA040449-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 417 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. are 18+ years old;
2. meet criteria for opioid use disorders of at least moderate severity (4 or 5 DSM-V criteria);
3. Are currently taking medication-assisted treatment (MAT) as part of their standard clinical care;
4. have no acute medical problem requiring immediate inpatient treatment;
5. have no history of psychotic disorders, though those with other co-morbid psychopathology (mood disorders, anxiety, other substance use disorders) will be eligible;
6. are willing to participate in a randomized clinical trial;
7. provide the name, verified telephone number, and address of at least 2 contacts willing to help locate the patient, if necessary, during follow-up;
8. are able to read and write in English;
9. are not pregnant;
10. are willing to share health-related data with primary care clinicians; and
11. 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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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417 participants in 2 patient groups, including a placebo group

Medication-assisted treatment (MAT)

Placebo Comparator group

Description:

Patients will receive standard medication-assisted treatment (MAT) as prescribed by their health care provider.

Treatment:

Other: MAT

MAT + A-CHESS

Experimental group

Description:

Patients in the MAT + A-CHESS arm will receive MAT as described plus the A-CHESS recovery support system via a smartphone.

Treatment:

Behavioral: MAT + A-CHESS