- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02846649
A Text Messaging Program to Help Prevent Early Opioid Relapse (PIER1)
2 maj 2017 uppdaterad av: Brian Suffoletto, University of Pittsburgh
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
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15261
- University of Pittsburgh Medical Center Emergency Department
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 60 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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
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Daily text message queries with tailored support
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
SMS query completion rate
Tidsram: 7 days
|
Investigators will report the percentage of SMS queries replied to over 7 days.
|
7 days
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of intentional opioid uses
Tidsram: 7 days
|
Investigators will report the number of self-reported opioid use occasions.
|
7 days
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Number of opioid overdoses
Tidsram: 7 days
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Investigators will report the number of self-reported opioid overdoses.
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7 days
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Ratings of usefulness
Tidsram: 7 days
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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
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7 days
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Brian Suffoletto, MD, University of Pittsburgh
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2016
Primärt slutförande (Faktisk)
1 december 2016
Avslutad studie (Faktisk)
1 december 2016
Studieregistreringsdatum
Först inskickad
6 juli 2016
Först inskickad som uppfyllde QC-kriterierna
24 juli 2016
Första postat (Uppskatta)
27 juli 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 maj 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 maj 2017
Senast verifierad
1 maj 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PRO15120183
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Ja
IPD-planbeskrivning
We will allow interested researchers access to a de-identified raw database
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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