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ACT + Care Management App for Opioid Use Disorder

N/A

Recruiting

Led By Tiffany Liu, MD

Research Sponsored by Albert Einstein College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years old or older

Be older than 18 years old

Must not have

Received ACT or similar therapeutic intervention in the past

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Summary

This trial will test if a combination of therapies can help those with both chronic pain and opioid addiction. The therapies include Acceptance and Commitment Therapy, as well as a care management smartphone app. Those affected will be engaged in all stages of the research.

Who is the study for?

This trial is for adults over 18 who are already receiving buprenorphine treatment for opioid use disorder and have chronic pain with moderate severity. Participants must speak English or Spanish and not be in new psychotherapy, using similar smartphone apps, or having recent changes in psychotropic meds.

What is being tested?

The study tests if Acceptance and Commitment Therapy (ACT) and a care management app can help people with chronic pain and opioid use disorder who are getting buprenorphine treatment. It aims to see how effective these approaches are when added to usual treatments.

What are the potential side effects?

While the trial doesn't involve medications that cause typical side effects, participants may experience emotional discomfort from therapy discussions or technical issues/frustrations with the smartphone application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have undergone ACT or a similar therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Opioid Use

Pain interference

Secondary study objectives

AAQ-SA

Alcohol Use

Anhedonia

+16 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: ACT + Valera appExperimental Treatment2 Interventions

Participants randomized to this cohort will receive both acceptance and commitment therapy (ACT) and the Valera app (and a smartphone with network connectivity if necessary).

Group II: Valera smartphone application (app) aloneActive Control1 Intervention

Participants randomized to this cohort will receive the Valera app and will receive a smartphone with network connectivity if necessary.

Group III: treatment as usual (TAU)Placebo Group1 Intervention

Participants randomized to this cohort will not receive any experimental treatments.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acceptance and commitment therapy

2019

N/A

~60