NCT02846649

Brief Summary

The objective is to determine feasibility and acceptability of a text message (SMS)-based relapse prevention intervention as measured through: (1) study retention and SMS query completion rates and (2) participant ratings of PIER1 interest, perceived efficacy, and ease of use. Methods: A mixed methods study of adult (age \>=18) ED patients who seek treatment for opioids and have evidence of dependence based on Rapid Opioid Dependence Screen (RODS) score of \>3 and are being discharged to outpatient (community) resources. All participants receive standard of care in the ED, complete a baseline web survey, are asked to text with us for at least 7 days (up to a max of 28 days) and are asked to complete a follow-up phone call between day 8 and 14. Investigators expect preliminary findings to support a relapse prevention intervention delivered through SMS. Based on feedback from this mixed methods study, investigators plan to test a refined SMS program in a randomized trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

July 6, 2016

Last Update Submit

May 2, 2017

Conditions

Substance-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • SMS query completion rate

    Investigators will report the percentage of SMS queries replied to over 7 days.

    7 days

Secondary Outcomes (3)

  • Number of intentional opioid uses

    7 days

  • Number of opioid overdoses

    7 days

  • Ratings of usefulness

    7 days

Study Arms (1)

PIER Intervention

EXPERIMENTAL

The program will help participants learn to recognize the presence of craving and how it can be reduced through environmental, self-regulatory and mood management. Each day, the PIER1 program sends (1) a morning reflection focused on positive thinking, (2) two random prompts assessing severity of craving, (3) feedback specific to managing withdrawal symptoms, mood management, and environmental triggers that are affecting craving, (4) evening assessments of drug use with feedback, (5) goal commitment prompt with feedback, and (6) user-triggered craving assessments with feedback

Behavioral: PIER

Interventions

PIERBEHAVIORAL

Daily text message queries with tailored support

PIER Intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 - 60 years
  • Seeking treatment for substance abuse (chief complaint of "detox")
  • English speaking
  • Opioid dependence (nursing history of opioid use + RODS score\>3)
  • Ownership of a mobile phone with text messaging
  • Medically and psychologically stable (as determined by the clinician or investigator)

You may not qualify if:

  • No mobile phone ownership or mobile phone without text messaging capabilities
  • Incarcerated/in police custody
  • Being treated for a self-inflicted injury or suicidal ideation (as determined by the clinician)
  • Medical condition affecting cognition (as determined by the clinician or investigator's discretion)
  • Unable to read, speak, or comprehend English (at the clinician or investigator's discretion)
  • Patients who are under the influence of illicit drugs or alcohol (at the clinician or investigator's discretion)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center Emergency Department

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Brian Suffoletto, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MS

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 27, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 5, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

We will allow interested researchers access to a de-identified raw database

Locations

US(1)