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

Opioid Use Disorder Clinical Trial

— Bundling  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712034
• Other study ID #: 2015-1418
• Secondary ID: 1R01DA040449-01A
• Status: Completed
• Phase: N/A
• Start date: April 21, 2016
• Est. completion date: April 8, 2020

Study information

• Verified date: April 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: April 8, 2020
• Est. primary completion date: April 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Opioid Use Disorder

Intervention

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).

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.

Locations

Country	Name	City	State
United States	Access Community Health Centers	Madison	Wisconsin

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid use	Detect the difference in illicit opioid use between patients who have MAT + A-CHESS vs. MAT alone.	24 months