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A Text Messaging Program to Help Prevent Early Opioid Relapse (PIER1)

Primary Purpose

Substance-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PIER
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Substance-Related Disorders

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Sites / Locations

  • University of Pittsburgh Medical Center Emergency Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PIER Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of intentional opioid uses
Investigators will report the number of self-reported opioid use occasions.
Number of opioid overdoses
Investigators will report the number of self-reported opioid overdoses.
Ratings of usefulness
Investigators will report the median self-reported usefulness rating (0=not at all, 1=somewhat useful; 2=moderately useful; 3=very useful; 4=extremely useful

Full Information

First Posted
July 6, 2016
Last Updated
May 2, 2017
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT02846649
Brief Title
A Text Messaging Program to Help Prevent Early Opioid Relapse
Acronym
PIER1
Official Title
Feasibility and Acceptability of Using an Automated Text Messaging Program to Help Prevent Early Relapse Among Treatment-seeking Opioid Dependent Patients Discharged From the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The vast majority of those with opioid dependence do not receive treatment. This may be due to the limited availability of existing treatment programs and to a range of societal and individual-level barriers, including the stigma associated with identifying oneself as a substance user and difficulty attending a treatment program on a regular basis. Technology-based interventions have potential to help address these barriers and to expand access to evidence-based psychosocial treatment. Automated, computer-based interventions have found high user acceptance and utilization and shown promise in treating substance use disorders. The current study will evaluate a text-message-based psychosocial program called PIER1 (Preventing and Interrupting Early Relapse 1) when delivered to treatment-seeking opioid-dependent emergency department (ED) patients. PIER1 is an interactive program based on the Relapse Prevention Model. It is also informed by cognitive behavioral therapy and motivational interviewing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PIER Intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
PIER
Intervention Description
Daily text message queries with tailored support
Primary Outcome Measure Information:
Title
SMS query completion rate
Description
Investigators will report the percentage of SMS queries replied to over 7 days.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Number of intentional opioid uses
Description
Investigators will report the number of self-reported opioid use occasions.
Time Frame
7 days
Title
Number of opioid overdoses
Description
Investigators will report the number of self-reported opioid overdoses.
Time Frame
7 days
Title
Ratings of usefulness
Description
Investigators will report the median self-reported usefulness rating (0=not at all, 1=somewhat useful; 2=moderately useful; 3=very useful; 4=extremely useful
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Suffoletto, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center Emergency Department
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will allow interested researchers access to a de-identified raw database

Learn more about this trial

A Text Messaging Program to Help Prevent Early Opioid Relapse

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