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Behavioral Intervention
Smartphone App for Opioid Use Disorder
N/A
Recruiting
Research Sponsored by Western Michigan University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 17-48
Awards & highlights
Summary
This trial aims to see if a smartphone app can help people with opioid use disorder. Participants will use the app to submit videos of themselves taking drug tests. The app also provides reminders, rewards, and
Who is the study for?
This trial is for adults over 18 in the U.S. who have opioid use disorder, can read and speak English, own a compatible smartphone, and have used opioids recently. They should be starting or already receiving medication-assisted treatment and have an ASAM CO-Triage score from L1 to L3.1.
What is being tested?
The study tests if a smartphone app providing reminders, rewards, cognitive-behavior therapy modules, wellness activities, and live support helps people with opioid addiction. Participants submit weekly drug test videos for one year.
What are the potential side effects?
Since this trial involves non-medical interventions like app-based services and support rather than drugs or medical procedures, traditional side effects are not applicable.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 17-48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 17-48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Independent lab-based salivary drug toxicology for abstinence from all unprescribed drugs (initial 16 weeks)
Secondary outcome measures
Days of Medications for Opioid Use Disorder (MOUD) adherence
Frequency of Adverse Events
Healthcare utilization
+2 moreOther outcome measures
Quality of Life assessment
Self-conducted abstinence from all unprescribed drugs
Self-reported drug use
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Abstinence reinforcementExperimental Treatment3 Interventions
Participants earn incentives for submission of salivary drug toxicology video selfies that show test results consistent with the goals of treatment. Goals are abstinence-based (i.e., relate to which tested substances should be negative on the test given the medications that the particular participant has been prescribed). Incentives are also provided for attendance at treatment-related appointments and for completion of self-paced cognitive behavior therapy modules available via the smartphone app.
Group II: Sample-contingent controlPlacebo Group3 Interventions
Identical to the experimental group except that incentives are available only for submission of selfie-videos that show test results, without regard to the results of the salivary drug toxicology test. Similarly, incentives are not provided for appointments or completion of wellness modules.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Contingency management
2006
Completed Phase 4
~1020
Find a Location
Who is running the clinical trial?
Western Michigan UniversityLead Sponsor
16 Previous Clinical Trials
2,628 Total Patients Enrolled
RTI InternationalOTHER
195 Previous Clinical Trials
816,933 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,543 Previous Clinical Trials
3,249,126 Total Patients Enrolled
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