A Text Messaging Program to Help Prevent Early Opioid Relapse

Substance-Related Disorders Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846649
• Other study ID #: PRO15120183
• Status: Completed
• Phase: N/A
• First received: July 6, 2016
• Last updated: May 2, 2017
• Start date: August 2016
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

Behavioral:
• PIER
Daily text message queries with tailored support

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center Emergency Department	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SMS query completion rate	Investigators will report the percentage of SMS queries replied to over 7 days.	7 days
Secondary	Number of intentional opioid uses	Investigators will report the number of self-reported opioid use occasions.	7 days
Secondary	Number of opioid overdoses	Investigators will report the number of self-reported opioid overdoses.	7 days
Secondary	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	7 days