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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02712034
Acronym
Bundling
Enrollment
417
Registered
2016-03-17
Start date
2016-04-21
Completion date
2020-04-08
Last updated
2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use Disorder

Keywords

Medication-assisted treatment (MAT), Buprenorphine, Methadone, Naltrexone

Brief summary

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).

Interventions

BEHAVIORALMAT + 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).

OTHERMAT

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.

Sponsors

Stanley Street Treatment and Resources (SSTAR)
CollaboratorUNKNOWN
Gosnold on Cape Cod
CollaboratorUNKNOWN
ARC Community Services, Inc.
CollaboratorUNKNOWN
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Opioid use24 monthsDetect the difference in illicit opioid use between patients who have MAT + A-CHESS vs. MAT alone.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026