Smartphone Apps for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

Overseen byAndrew James, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Arkansas

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The proposed clinical trial would evaluate the use of smartphone applications ("apps", which have well-established efficacy in reducing cigarette and alcohol use) to prevent relapse among patients receiving medication-assisted treatment for opioid use disorder. In addition to standard app-based self-monitoring of drug use and personalized feedback, project innovation is enhanced by the proposed use of location-tracking technology for targeted, personalized intervention when participants enter self-identified areas of high risk for relapse. Furthermore, the proposed sub-study would use longitudinal functional neuroimaging to elucidate the brain-cognition relationships underlying individual differences in treatment outcomes, offering broad significance for understanding and enhancing the efficacy of this and other app-based interventions.

Eligibility Criteria

Adults over 18 with opioid use disorder in early phase medication-assisted treatment can join. For the MRI study, participants must be 18-50 years old, native English speakers, and not pregnant or have certain medical conditions. They should agree to use a smartphone for the intervention.

Inclusion Criteria

I am either male or female.

I am in the initial phase of treatment for opioid addiction, receiving weekly medication.

I am 18 years old or older.

+3 more

Exclusion Criteria

I have no history of serious neurological, heart diseases, infections, or significant brain injuries.

(MRI) MRI contraindications: Exclusion criteria for MRI include (1) the presence of non-removable internal (e.g., cardiac pacemakers, aneurysm clips, artificial joints) or external (e.g., piercings, orthodontics) ferromagnetic objects; (2) claustrophobia in a confined MRI environment; (3) medications that interfere with hemodynamic coupling (e.g., beta blockers); (4) hypersensitivity to loud noise; or (5) a body circumference exceeding 60cm due to broad shoulders or morbid obesity

(MRI) Pregnancy: A positive test for pregnancy prior to fMRI would exclude participation, due to unknown effect of high-field MRI on developing fetus.

Participant Groups

The trial tests if smartphone apps can help prevent relapse in opioid addiction by monitoring drug use and providing feedback. It includes location-tracking for real-time support in high-risk areas and uses MRI scans to study brain changes linked to treatment success.

2Treatment groups

Experimental Treatment

Active Control

Group I: SmartphoneExperimental Treatment1 Intervention

Participants randomized into the Smartphone app arm would use the smartphone app OptiMAT in conjunction with treatment as usual (TAU). Participants would use OptiMAT to complete daily self-assessments of opiate misuse, opiate craving, opiate withdrawal, and mood. The app will personalized feedback for maintaining abstinence goals. The app would also use geographic ecological momentary assessment (GEMA) to intervene via push notification when participants enter areas previously identified as high-risk for opiate use.

Group II: Monitoring OnlyActive Control1 Intervention

Participants randomized into the Monitoring Only arm would undergo treatment as usual (TAU) but without the smartphone app.