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OpenTrials
Completed

NCT Number: NCT02846649

A Text Messaging Program to Help Prevent Early Opioid Relapse

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center Emergency Department

Pittsburgh, Pennsylvania, 15261, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PIER

Behavioral

Daily text message queries with tailored support

Primary outcomes

  1. SMS query completion rate

    Time frame: 7 days

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

Secondary outcomes

  1. Number of intentional opioid uses

    Time frame: 7 days

    Investigators will report the number of self-reported opioid use occasions.

  2. Number of opioid overdoses

    Time frame: 7 days

    Investigators will report the number of self-reported opioid overdoses.

  3. Ratings of usefulness

    Time frame: 7 days

    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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study 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

Acronym: PIER1

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 27, 2016
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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