Clinical trial NCT02712034: Impact on Opioid Use of Bundling Medication-assisted Treatment With mHealth
Official title: Impact on Opioid Use of Bundling Medication-assisted Treatment With mHealth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Medication-assisted treatment (MAT)
Buprenorphine
Methadone
Naltrexone
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Stanley Street Treatment and Resources (SSTAR)
name: Gosnold on Cape Cod
name: ARC Community Services, Inc.
name: National Institute on Drug Abuse (NIDA)
First posted: 2016-03-17
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility criteria: 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).

Primary outcomes:
measure: Opioid use
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Access Community Health Centers
state: Wisconsin
Study officials:
affiliation: UW Madison
name: David H Gustafson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.