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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

417 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-21

Study Completion Date

2020-04-08

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).

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Detailed Description

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Conditions

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Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Medication-assisted treatment (MAT)

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

Group Type PLACEBO_COMPARATOR

MAT

Intervention Type OTHER

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.

MAT + A-CHESS

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

Group Type EXPERIMENTAL

MAT + A-CHESS

Intervention Type BEHAVIORAL

Subjects randomized to MAT + A-CHESS will receive MAT plus the A-CHESS recovery support system which provides:

1. Self-directed, interactive modules that teach basic recovery support, harm-reduction, and psychosocial functioning skills.
2. The latest information about addiction and recovery support, monitoring prompts, and peer and family support.
3. Advice on where to go for help and on how to make the best use of health and human services; and
4. 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.
5. 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).

Interventions

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MAT + A-CHESS

Subjects randomized to MAT + A-CHESS will receive MAT plus the A-CHESS recovery support system which provides:

1. Self-directed, interactive modules that teach basic recovery support, harm-reduction, and psychosocial functioning skills.
2. The latest information about addiction and recovery support, monitoring prompts, and peer and family support.
3. Advice on where to go for help and on how to make the best use of health and human services; and
4. 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.
5. 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).

Intervention Type BEHAVIORAL

MAT

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.

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes