Clinical trial NCT03842384: Digital Health Intervention to Support Opioid Use Disorder Treatment
Official title: iENDURE: Digital Health Intervention to Support Opioid Use Disorder Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Treatment Adherence
Keywords: Buprenorphine
Digital Health
Medication for Opioid Use Disorder
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-02-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Self-Reported Buprenorphine Adherence
timeFrame: Participants will be asked to report on daily use up to 1-, 4-, 8- and 12- week following medication induction.
measure: Self-Reported Illicit Substance Use
timeFrame: Participants will be asked to report on daily use up to 1-, 4-, 8- and 12- week following medication induction.
measure: Biochemically Verified Buprenorphine Adherence
timeFrame: Performed at 1-, 4-, 8- and 12- week following medication induction.
measure: Biochemically Verified Illicit Substance Use
timeFrame: Performed at 1-, 4-, 8- and 12- week following medication induction.
Secondary outcomes:
measure: Readiness Ruler
timeFrame: 1-, 4-, 8-, and 12-weeks post medication induction.
measure: Confidence Scale
timeFrame: 1-, 4-, 8-, and 12-weeks post medication induction.
measure: Distress Tolerance Scale
timeFrame: 1-, 4-, 8-, and 12-weeks post medication induction.
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Kirsten J Langdon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langdon KJ, Ramsey S, Scherzer C, Carey K, Ranney ML, Rich J. Development of an integrated digital health intervention to promote engagement in and adherence to medication for opioid use disorder. Addict Sci Clin Pract. 2020 Apr 29;15(1):16. doi: 10.1186/s13722-020-00189-4.