Substance-Related DisordersPIER1NCT02846649
A Text Messaging Program to Help Prevent Early Opioid Relapse
A study testing PIER in people with Substance-Related Disorders, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- PIER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center Emergency Department
Pittsburgh, Pennsylvania, 15261
About this study
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
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.
Read the 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
- Being tested
- PIER
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIERBehavioural
Daily text message queries with tailored support
| Study group | Role | What they receive |
|---|---|---|
| PIER Intervention | Experimental | 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 Receives: Behavioral: PIER |
What is being measured
The primary outcome is the main question the study is designed to answer.
SMS query completion rate
Investigators will report the percentage of SMS queries replied to over 7 days.
Measured: 7 days
Secondary outcomes (3)
Number of intentional opioid uses
Investigators will report the number of self-reported opioid use occasions.
Measured: 7 days
Number of opioid overdoses
Investigators will report the number of self-reported opioid overdoses.
Measured: 7 days
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Suffoletto, University of Pittsburgh
- Investigators
- Brian Suffoletto, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846649
- Sponsor's protocol ID
- PRO15120183
- Acronym
- PIER1
- Status last verified
- May 2017
- First submitted
- 6 Jul 2016
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We will allow interested researchers access to a de-identified raw database
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02846649
- Acronym / sponsor ID
- PIER1 / PRO15120183
- Conditions
- Substance-Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PIER Intervention | Experimental | Behavioral: PIERThe 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIERDaily text message queries with tailored support | Behavioural | PIER Intervention |
Primary outcome
SMS query completion rate
Time frame: 7 days
Investigators will report the percentage of SMS queries replied to over 7 days.
3 secondary outcomes
Number of intentional opioid uses
Time frame: 7 days
Number of opioid overdoses
Time frame: 7 days
Ratings of usefulness
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Individual participant dataSharing planned: Yes. We will allow interested researchers access to a de-identified raw database
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Suffoletto, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIER in people with Substance-Related Disorders, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SMS query completion rate (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.