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Digital Health Intervention for Opioid Use Disorder (iENDURE Trial)

N/A

Waitlist Available

Led By Kirsten Langdon, PhD

Research Sponsored by Rhode Island Hospital

Eligibility Criteria Checklist

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

Must have

current buprenorphine prescription

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-, 4-, 8-, and 12-weeks post medication induction.

Awards & highlights

iENDURE Trial Summary

This trial will compare a new computer- and text message-based intervention to usual care in order to see if the intervention can help people better tolerate the early phase of buprenorphine treatment.

Who is the study for?

This trial is for adults over 18 with Opioid Use Disorder who are currently prescribed buprenorphine. Participants must have a cell phone capable of texting and understand English. Those with active suicidal thoughts, psychosis, or without a phone data plan cannot join.Check my eligibility

What is being tested?

The study tests iENDURE, a digital intervention combining computer and text messaging to boost motivation and distress tolerance during early buprenorphine treatment for opioid addiction. It's compared to standard care in a preliminary trial involving 80 participants.See study design

What are the potential side effects?

Since iENDURE is a digital intervention focusing on motivational messages and support through technology, it does not have direct medical side effects like drugs do; however, there may be psychological impacts or stress related to engagement with the program.

iENDURE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am currently prescribed buprenorphine.

iENDURE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-, 4-, 8-, and 12-weeks post medication induction.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-, 4-, 8-, and 12-weeks post medication induction.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-, 4-, 8-, and 12-weeks post medication induction. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Biochemically Verified Buprenorphine Adherence

Biochemically Verified Illicit Substance Use

Self-Reported Buprenorphine Adherence

+1 more

Secondary outcome measures

Confidence Scale

Distress Tolerance Scale

Readiness Ruler

iENDURE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: iENDUREExperimental Treatment1 Intervention

iENDURE involves two delivery modes: computer and text message. The intervention initially targets motivational processes in combination with introductory strategies for managing physical and emotional distress through a single, brief, computer-delivered session followed by eight weeks of theoretically-informed text messages intended to enhance motivation and promote distress tolerance (DT).

Group II: Treatment-as-UsualActive Control1 Intervention

Participants in the TAU comparison control group will engage in buprenorphine treatment as determined by their clinical team. This could include medication evaluations, individual or group counseling, case management or peer recovery. TAU was selected as the comparison condition as it represents a robust and evidence-based approach to the treatment of OUD.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

iENDURE

2020

N/A

~80

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor

260 Previous Clinical Trials

66,927 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,468 Previous Clinical Trials

2,619,268 Total Patients Enrolled

Kirsten Langdon, PhDPrincipal InvestigatorRhode Island Hospital

1 Previous Clinical Trials

10 Total Patients Enrolled

Media Library

Distress Tolerance Training Clinical Trial Eligibility Overview. Trial Name: NCT03842384 — N/A

Opioid Use Disorder Research Study Groups: iENDURE, Treatment-as-Usual

Opioid Use Disorder Clinical Trial 2023: Distress Tolerance Training Highlights & Side Effects. Trial Name: NCT03842384 — N/A

Distress Tolerance Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT03842384 — N/A

Frequently Asked Questions

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

How many individuals is the study recruiting to participate?

"Affirmative. Clinicaltrials.gov's information reveals that, as of April 4th 2022, this research is actively recruiting patients. The initial post was on October 1st 2020 and the goal is to enrol 80 individuals from a single medical centre."

Answered by AI

Are there any vacancies left for participation in this trial?

"Yes, the information available on clinicaltrials.gov implies that this experiment is actively looking for volunteers. It was first announced on October 1st 2020 and its details were most recently revised in April 4th 2022. 80 participants are being recruited from a single medical center."

Answered by AI

Recent research and studies

Addiction Science & Clinical PracticeJournal

Development of an Integrated Digital Health Intervention to Promote Engagement in and Adherence to Medication for Opioid Use Disorder

Langdon, Kirsten J., Susan Ramsey, Caroline Scherzer, Kate Carey, Megan L. Ranney, and Josiah Rich. 2020. “Development of an Integrated Digital Health Intervention to Promote Engagement in and Adherence to Medication for Opioid Use Disorder”. Addiction Science & Clinical Practice. Springer Science and Business Media LLC. doi:10.1186/s13722-020-00189-4.

clinicaltrials.govStudy

Digital Health Intervention to Support Opioid Use Disorder Treatment

2020. "Digital Health Intervention to Support Opioid Use Disorder Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03842384.