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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 belowSelect...
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.
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 moreSecondary 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
Find a Location
Who is running the clinical trial?
Rhode Island HospitalLead Sponsor
261 Previous Clinical Trials
68,926 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,485 Previous Clinical Trials
2,622,300 Total Patients Enrolled
Kirsten Langdon, PhDPrincipal InvestigatorRhode Island Hospital
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You do not have access to a mobile phone plan with data.I am currently prescribed buprenorphine.I am not currently experiencing thoughts of suicide or psychosis.I am not fluent in English.
Research Study Groups:
This trial has the following groups:- Group 1: iENDURE
- Group 2: Treatment-as-Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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