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

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT02712034
Collaborator
Stanley Street Treatment and Resources (SSTAR) (Other), Gosnold on Cape Cod (Other), ARC Community Services, Inc. (Other), National Institute on Drug Abuse (NIDA) (NIH)
417
1
2
47.6
8.8

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: MAT + A-CHESS
  • Other: MAT
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
417 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Impact on Opioid Use of Bundling Medication-assisted Treatment With mHealth
Actual Study Start Date :
Apr 21, 2016
Actual Primary Completion Date :
Apr 8, 2020
Actual Study Completion Date :
Apr 8, 2020

Arms and Interventions

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: 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).

Outcome Measures

Primary Outcome Measures

  1. Opioid use [24 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Access Community Health Centers Madison Wisconsin United States 53713

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT02712034
Other Study ID Numbers:
  • 2015-1418
  • 1R01DA040449-01
  • A195010
  • INDUSTRIAL ENGR\CHESS PROG
First Posted:
Mar 17, 2016
Last Update Posted:
Apr 14, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University of Wisconsin, Madison
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2020