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

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).

Completed

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Access Community Health Centers

Madison, Wisconsin, 53713, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

MAT + A-CHESS

Behavioral

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).

MAT

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.

Primary outcomes

Opioid use

Time frame: 24 months

Detect the difference in illicit opioid use between patients who have MAT + A-CHESS vs. MAT alone.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

ARC Community Services, Inc.
Gosnold on Cape Cod
National Institute on Drug Abuse (NIDA)
Stanley Street Treatment and Resources (SSTAR)

Registry information

Acronym: Bundling

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Mar 17, 2016
Registry last updated: Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed