Digital Health Intervention to Support Opioid Use Disorder Treatment

NCT03842384 | Completed DMC

• 1 other identifier: K23DA046482
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Opioid Use Disorder; Treatment Adherence

Keywords

Buprenorphine; Digital Health; Medication for Opioid Use Disorder

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (3)

• Readiness Ruler

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

• Confidence Scale

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

• Distress Tolerance Scale

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

Study Arms (2)

iENDURE

EXPERIMENTAL

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).

Behavioral: iENDURE

Treatment-as-Usual

NO 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.

Interventions

iENDURE BEHAVIORAL

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.

iENDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• 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.

  PMID: 32349790 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Study Officials

• Kirsten J Langdon, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: October 1, 2020
• Primary Completion: August 7, 2023
• Study Completion: November 15, 2023
• Last Updated: April 10, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)