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

Primary Purpose

Opioid Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MAT + A-CHESS
MAT
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opioid Use Disorder focused on measuring Medication-assisted treatment (MAT), Buprenorphine, Methadone, Naltrexone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Access Community Health Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Medication-assisted treatment (MAT)

MAT + A-CHESS

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 14, 2016
Last Updated
April 10, 2020
Sponsor
University of Wisconsin, Madison
Collaborators
Stanley Street Treatment and Resources (SSTAR), Gosnold on Cape Cod, ARC Community Services, Inc., National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02712034
Brief Title
Impact on Opioid Use of Bundling Medication-assisted Treatment With mHealth
Acronym
Bundling
Official Title
Impact on Opioid Use of Bundling Medication-assisted Treatment With mHealth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 21, 2016 (Actual)
Primary Completion Date
April 8, 2020 (Actual)
Study Completion Date
April 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Stanley Street Treatment and Resources (SSTAR), Gosnold on Cape Cod, ARC Community Services, Inc., National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
Medication-assisted treatment (MAT), Buprenorphine, Methadone, Naltrexone

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
417 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medication-assisted treatment (MAT)
Arm Type
Placebo Comparator
Arm Description
Patients will receive standard medication-assisted treatment (MAT) as prescribed by their health care provider.
Arm Title
MAT + A-CHESS
Arm Type
Experimental
Arm Description
Patients in the MAT + A-CHESS arm will receive MAT as described plus the A-CHESS recovery support system via a smartphone.
Intervention Type
Behavioral
Intervention Name(s)
MAT + A-CHESS
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
MAT
Intervention Description
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 Outcome Measure Information:
Title
Opioid use
Description
Detect the difference in illicit opioid use between patients who have MAT + A-CHESS vs. MAT alone.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H Gustafson, PhD
Organizational Affiliation
UW Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Access Community Health Centers
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33616545
Citation
Hochstatter KR, Gustafson DH Sr, Landucci G, Pe-Romashko K, Cody O, Maus A, Shah DV, Westergaard RP. Effect of an mHealth Intervention on Hepatitis C Testing Uptake Among People With Opioid Use Disorder: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Feb 22;9(2):e23080. doi: 10.2196/23080.
Results Reference
derived
PubMed Identifier
31373273
Citation
Hochstatter KR, Gustafson DH Sr, Landucci G, Pe-Romashko K, Maus A, Shah DV, Taylor QA, Gill EK, Miller R, Krechel S, Westergaard RP. A Mobile Health Intervention to Improve Hepatitis C Outcomes Among People With Opioid Use Disorder: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Aug 1;8(8):e12620. doi: 10.2196/12620.
Results Reference
derived
PubMed Identifier
27955689
Citation
Gustafson DH Sr, Landucci G, McTavish F, Kornfield R, Johnson RA, Mares ML, Westergaard RP, Quanbeck A, Alagoz E, Pe-Romashko K, Thomas C, Shah D. The effect of bundling medication-assisted treatment for opioid addiction with mHealth: study protocol for a randomized clinical trial. Trials. 2016 Dec 12;17(1):592. doi: 10.1186/s13063-016-1726-1.
Results Reference
derived

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

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