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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

CP with at least moderate pain severity (score greater than or equal to 4 on Pain, Enjoyment of Life and General Activity scale (PEG). Comorbid psychiatric conditions and use of psychotropic medications will be allowed.

18 years old or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I experience moderate to severe chronic pain.

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I am 18 years old or older.

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I have been on a stable dose of BUP for OUD treatment at Montefiore for over a month.

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I am proficient in English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Opioid Use

Pain interference

Secondary outcome measures

AAQ-SA

Alcohol Use

Anhedonia

+15 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: ACT + Valera appExperimental Treatment2 Interventions

Participants randomized to this cohort will receive both 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: acceptance and commitment therapy (ACT) aloneActive Control1 Intervention

Participants randomized to this cohort will receive only acceptance and commitment therapy.

Group IV: 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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor

286 Previous Clinical Trials

11,856,701 Total Patients Enrolled

Tiffany Liu, MDPrincipal InvestigatorMontefiore

Brianna Norton, DOPrincipal InvestigatorMontefiore

Media Library

Acceptance and commitment therapy Clinical Trial Eligibility Overview. Trial Name: NCT05039554 — N/A

Acceptance and commitment therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05039554 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies left for participation in this research project?

"Clinicaltrials.gov confirms that this trial, initially posted on November 1st 2022 and last modified on October 19th 2022 is no longer recruiting patients. While the search for participants has been concluded, there are 664 other trials seeking enrollees at present."

Answered by AI

What is the projected result of this research endeavor?

"The primary metric for success of this 24 week trial is Pain interference. Secondary goals include assessing Substance use urges with the AAQ-SA, urine toxicology tests to measure Substance use, and ASI testing to gauge off-opioid Substance consumption."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment

Vilma Gabbay 2023. "Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05039554.

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