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

April 10, 2020 updated by: University of Wisconsin, Madison
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

417

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53713
        • Access Community Health Centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Medication-assisted treatment (MAT)
Patients will receive standard medication-assisted treatment (MAT) as prescribed by their health care provider.
Other: 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.
Experimental: 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.
Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

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

Investigators

  • Principal Investigator: David H Gustafson, PhD, UW Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2016

Primary Completion (Actual)

April 8, 2020

Study Completion (Actual)

April 8, 2020

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-1418
  • A195010 (Other Identifier: UW Madison)
  • 1R01DA040449-01 (U.S. NIH Grant/Contract)
  • INDUSTRIAL ENGR\CHESS PROG (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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