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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02712034
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : October 16, 2017
Stanley Street Treatment and Resources (SSTAR)
Gosnold on Cape Cod
ARC Community Services, Inc.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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
Opioid Use Disorder Behavioral: MAT + A-CHESS Other: MAT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 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
Study Start Date : April 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : August 2020

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).

Primary Outcome Measures :
  1. Opioid use [ Time Frame: 24 months ]
    Detect the difference in illicit opioid use between patients who have MAT + A-CHESS vs. MAT alone.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02712034

Contact: Gina M Landucci, BS 1-800-361-5481

United States, Wisconsin
Access Community Health Centers Recruiting
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)
Principal Investigator: David H Gustafson, PhD UW Madison

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison Identifier: NCT02712034     History of Changes
Other Study ID Numbers: 2015-1418
1R01DA040449-01 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Wisconsin, Madison:
Medication-assisted treatment (MAT)

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists