A Text Messaging Program to Help Prevent Early Opioid Relapse

NCT ID: NCT02846649

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2016-12-31

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.

Conditions

Substance-Related Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PIER Intervention

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

Group Type: EXPERIMENTAL

PIER

Intervention Type: BEHAVIORAL

Daily text message queries with tailored support

Interventions

PIER

Daily text message queries with tailored support

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Brian Suffoletto

MD, MS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Suffoletto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center Emergency Department

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO15120183

Identifier Type: -

Identifier Source: org_study_id