Digital Health Intervention to Support Opioid Use Disorder Treatment

Opioid Use Disorder Clinical Trial

— iENDURE  

Official title:

iENDURE: Digital Health Intervention to Support Opioid Use Disorder Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03842384
• Other study ID #: K23DA046482
• Secondary ID: K23DA046482
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: November 15, 2023

Study information

• Verified date: March 2023
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In prior studies, the investigative team developed a combined computer- and text message-delivered personalized-feedback intervention (iENDURE) designed to enhance motivation and improve tolerance of distress to support the early phase of buprenorphine treatment. Specific aims of this subsequent study include conducting a preliminary randomized controlled trial with 80 participants to examine the efficacy of iENDURE relative to Treatment-as-Usual (TAU).

Description:

Medication for Opioid Use Disorder (MOUD), which includes the use of Methadone, Buprenorphine, or long-acting Naltrexone, is an evidence-based approach to the treatment of Opioid Use Disorder. Buprenorphine, a partial opioid agonist, has grown in popularity over the last decade because of its safety profile and flexible administration. Despite its advantages, nearly half of participants are unable to achieve stabilization, and many discontinue treatment or return to illicit opioid use. Given high rates of noncompliance and/or dropout, there have been recent calls to find innovative interventions to enhance motivation, adherence, and retention in MOUD. Distress tolerance (DT), the perceived or actual ability to handle aversive physical or emotional states, is a transdiagnostic vulnerability factor implicated in the development and maintenance of affective symptoms/disorders and substance use. Preliminary work suggests that targeting DT during treatment may improve outcomes, by promoting the ability to persist in goal directed activity (e.g., abstinence) even when experiencing distress. Accordingly, an intervention that cultivates motivation for abstinence above the reinforcing effects of opioids and teaches adaptive distress tolerance strategies may optimize the induction and stabilization phases of buprenorphine treatment to improve long-term recovery. Personalized-feedback interventions, such as decisional balance feedback evaluating the advantages/disadvantages of engaging in a certain behavior, represent a promising method to enhance engagement in buprenorphine treatment. Digital health interventions have the capability of reaching a variety of patient populations and are well-suited to offer support, skills training, and reminders during times of increased distress that occur in 'real-time' outside of structured treatment settings. The objective of this study is to test the preliminary efficacy of a combined computer- and text message-delivered intervention for adults initiating buprenorphine treatment for opioid use disorder.

Following consent procedures, all participants will complete a brief online survey and then be randomly assigned to receive either (a) iENDURE, a computer- and text message-delivered intervention, or (b) treatment-as-usual and no additional intervention. All participants, regardless of treatment group, will complete a second set of questionnaires following randomization. All participants will also be scheduled for follow-up assessments at 1-, 4-, 8- and 12-weeks. Participants assigned to treatment-as-usual will engage in care as determined by their treatment team. Participants randomized to the iENDURE group will also engage in routine clinical care, however, they will additionally complete a brief computer intervention introducing designed to enhance motivation through a decisional balance exercise and improve tolerance of distress through skills training. Information obtained in the computer intervention will be used to personalize the subsequent text message portion of the intervention. Participants will receive 8 weeks of personalized text messages that will a) remind of salient motivational factors, and b) provide recommendations for relevant distress tolerance skills. Finally, participants in the iENDURE treatment condition will be asked to complete a individual qualitative interview at the conclusion of the intervention to elicit feedback for further improvement and refinement of the iENDURE program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 15, 2023
• Est. primary completion date: August 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18+ years; current DSM-5 diagnosis of Opioid Use Disorder; current buprenorphine prescription; and access to cell phone with text message capability.

Exclusion Criteria:

• active suicidality and/or psychosis; not fluent in English; not having a phone data plan.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders
• Treatment Adherence

Intervention

Behavioral:
• iENDURE
The proposed intervention will initially target 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.

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Reported Buprenorphine Adherence	The Timeline Follow-Back will be used to collect self-report data on daily buprenorphine adherence. Adherence is recorded as either 0 (prescribed dose not taken) or 1 (prescribed dose taken). Buprenorphine adherence will be operationalized as the percentage of days positive for buprenorphine administration.	Participants will be asked to report on daily use up to 1-, 4-, 8- and 12- week following medication induction.
Primary	Self-Reported Illicit Substance Use	The Timeline Follow-Back will be used to collect self-report data on daily illicit substance use. Illicit substance use will be recorded as either 0 (no illicit substance use) or 1 (illicit substance use). Illicit substance use will be operationalized as the percentage of days positive for drug use (separate by drug class).	Participants will be asked to report on daily use up to 1-, 4-, 8- and 12- week following medication induction.
Primary	Biochemically Verified Buprenorphine Adherence	Urine samples will be collected and tested to confirm adherence to buprenorphine. A 5 ng/mL urine buprenorphine cutoff will be indicative of compliance with buprenorphine treatment.	Performed at 1-, 4-, 8- and 12- week following medication induction.
Primary	Biochemically Verified Illicit Substance Use	Urine samples will be collected and tested to confirm or deny use of other illicit substances.	Performed at 1-, 4-, 8- and 12- week following medication induction.
Secondary	Readiness Ruler	Brief assessment of a person's present motivational state relative to changing a specific behavior. In this study, the Readiness Ruler will assess participants' motivation to change use of illicit opioids. The ruler is based upon a likert scale ranging from 1 (Definitely NOT Ready to Change) to 10 (Definitely Ready to Change). Higher scores reflect greater motivation to change.	1-, 4-, 8-, and 12-weeks post medication induction.
Secondary	Confidence Scale	This item assesses participant's confidence in meeting their recovery goals. Participants are prompted "Please indicate to what extent you feel confident in reaching your goals for treatment" and were expected to respond on a 11-point Likert scale, ranging from "0" = "I do not think I will reach my goals" and "10" = "I think I will definitely reach my goals". Higher score indicated greater levels of confidence in meeting goals.	1-, 4-, 8-, and 12-weeks post medication induction.
Secondary	Distress Tolerance Scale	The Distress Tolerance Scale is a 15-item self-report measure in which respondents indicate, on a 5-point Likert-type scale (1 = strongly agree to 5 = strongly disagree), the extent to which they can experience and withstand distressing psychological states. Higher total scores reflect greater ability to tolerate distress. The total score is computed as a mean, with a possible range of 1-5.	1-, 4-, 8-, and 12-weeks post medication induction.