Clinical trial NCT02846649: A Text Messaging Program to Help Prevent Early Opioid Relapse
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
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: SMS query completion rate
timeFrame: 7 days
Secondary outcomes:
measure: Number of intentional opioid uses
timeFrame: 7 days
measure: Number of opioid overdoses
timeFrame: 7 days
measure: Ratings of usefulness
timeFrame: 7 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Emergency Department
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Brian Suffoletto, MD
role: PRINCIPAL_INVESTIGATOR
References: