Opioid Use DisorderNCT05897788
Text-Messaging Telehealth and Contingency Management for Opioid Use Disorder Treatment Engagement
A study testing Text Message Check-ins and Contingency Management in people with Opioid Use Disorder and Opioid Dependence With Current Use (Disorder), run by University of Pennsylvania at 1 site in United States.
Trial summary
There is growing recognition of the need for approaches to initiate treatment wherever patients touch the health care system, including the Emergency Department (ED). Most research has focused on initiation of medications for opioid use disorder (MOUDs) in the ED rather than ensuring continued treatment… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder, Opioid Dependence With Current Use (Disorder)
- What is being tested?
- Text Message Check-ins and Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,808 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be 18 or older
- Screen positive for OUD
- Bridge buprenorphine prescription (emergency department (ED) enrollment - Buprenorphine prescription at ED discharge; Bridge clinic enrollment - new buprenorphine prescription associated with on-demand or drop-in encounter
- English reading ability
- Have a mobile phone capable of receiving text messages
Who cannot join
- Not being up to date with requirements above
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
There is growing recognition of the need for approaches to initiate treatment wherever patients touch the health care system, including the Emergency Department (ED). Most research has focused on initiation of medications for opioid use disorder (MOUDs) in the ED rather than ensuring continued treatment post-discharge. The investigators propose to adapt evidence-based interventions to support patients' complex needs and facilitate continued treatment, rather than discharging them and having them navigate outpatient treatment systems with limited support. The research team will randomize participants into 1 of 4 arms to receive varying degrees of augmented usual care, including daily check-ins and contingency management. The investigators plan to examine the effects of check-ins and contingency management on engagement with addiction treatment and equity of treatment effects among racial and ethnic subgroups and assess important moderators of treatment effects.
Read the detailed description
The investigators are proposing to conduct a randomized controlled trial to determine the effectiveness of various text-based and contingency management interventions on Opioid Use Disorder patients. Our goals are to measure their engagement with recovery treatment. The research team plan to enroll 1,649 participants into one of the following 4 arms.
Patients enrolled into the Way to Health CareConnect text line as part of usual care and meeting eligibility criteria will be enrolled in this randomized control trial and randomized to:
Augmented usual care (standard Way to HealthCareConnect text line) Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week.
Augmented usual care + text-message check-ins (standard Way to Health CareConnect Text line) Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week AND (text-message check-ins) patients will receive automated text-message check-ins up to once per day for 30 days to see if the patient needs help with anything.
Augmented usual care + contingency management (standard Way to Health CareConnect Text line) and, participants will be compensated for going to their follow-up appointments.
Augmented usual care + CM + Text-message check-ins (standard Way to Health CareConnect text line) AND text-message check-ins-patients will receive automated text-message check-ins up to once per day for 30 days to see if the patient needs help with anything AND, participants will receive compensation for attending their follow-up appointments.
Patients enrolled in the trial will also be invited to complete the intake survey and follow-up surveys. Patients will receive financial compensation for completing these surveys. The study team plans to enroll 1,649 participants for this study.
- Being tested
- Text Message Check-ins, Contingency Management
- Keywords
- Opioid use disorder, Contingency Management, text-based interventions
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message Check-insBehavioural
Patients will receive automated text-message check-ins up to once per day for 30 days to see if the patient needs help with anything AND patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week.
Contingency ManagementBehavioural
Patients will receive incentives for engagement with treatment. Participant will receive compensation for filling their buprenorphine scripts at discharge and attending their follow-up care appointments.
| Study group | Role | What they receive |
|---|---|---|
| Augmented Usual Care (AUC) | No intervention | AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6. |
| Augmented usual care + text-message check-ins | Active comparator | AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week.
Text check-in: Patients will also receive incentives for engagement with treatment and
Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6. Receives: Behavioral: Text Message Check-ins |
| Augmented Usual care + Contingency Management (CM) | Active comparator | AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week.
Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6.
CM: Patients will also receive incentives for engagement with treatment. Receives: Behavioral: Contingency Management |
| Augmented usual care + text-message check-ins + contingency management | Active comparator | AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week.
Text check-in: Patients will also receive incentives for engagement with treatment and
Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6.
CM: Patients will also receive incentives for engagement with treatment. Receives: Behavioral: Text Message Check-ins; Behavioral: Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in any addiction treatment at 30 days of randomization
Engagement in any addiction treatment within 30 days of randomization (measured on day 31)
Measured: 31 days
Secondary outcomes (2)
ED and Hospital Utilization and mortality
Subsequent ED and hospital utilization and mortality. The investigators have developed standardized data queries to capture all ED visits, hospitalizations, and mortality out to 6 months from enrollment. To capture encounters outside study health systems, the study team will obtain linked records from the regional health information exchanges (HIEs) - HealthShare Exchange for Penn and Cooper, Care Everywhere for Alameda). Will subsequently link the patient data to the National Death Index to capture of out-of-hospital mortality not captured in Electronic Health Records (EHRs) or HIEs.
Measured: 6 months
Engagement in addition treatment within 14 days
Engagement in any addiction treatment within 14 days of randomization (measured on day 15)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start20 Mar 2024
- Primary completion30 May 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Randomised
- Intervention model
- Factorial
- Model description
- Patients enrolled into the Way to Health CareConnect text line as part of usual care and meeting eligibility criteria will be enrolled in this randomized control trial and randomized to: Augmented usual care, standard Way to Health CareConnect text line Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Augmented usual care + text-message check-ins, standard Way to Health CareConnect Text line Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week AND (text-message check-ins) patients will receive automated text-message check-ins up to once per day for 30 days to see if the patient needs help with anything. Augmented usual care + contingency management (standard Way to Health CareConnect Text line) and, participants will be compensated for going to their follow-up appointments.
- Masking
- None (open label)
- Enrolment
- 1,808 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, M. Kit Delgado, MD, University of Pennsylvania
- Investigators
- Kit Delgado, MD, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897788
- Sponsor's protocol ID
- 853153
- Status last verified
- Jul 2026
- First submitted
- 23 May 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text-Messaging Telehealth and Contingency Management for Opioid Use Disorder Treatment Engagement
- ClinicalTrials.gov ID
- NCT05897788
- Acronym / sponsor ID
- 853153
- Keywords
- Opioid use disorder, Contingency Management, text-based interventions
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,808 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 9 Jun 2023 (actual)
- 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.
There is growing recognition of the need for approaches to initiate treatment wherever patients touch the health care system, including the Emergency Department (ED). Most research has focused on initiation of medications for opioid use disorder (MOUDs) in the ED rather than ensuring continued treatment post-discharge. The investigators propose to adapt evidence-based interventions to support patients' complex needs and facilitate continued treatment, rather than discharging them and having them navigate outpatient treatment systems with limited support. The research team will randomize participants into 1 of 4 arms to receive varying degrees of augmented usual care, including daily check-ins and contingency management. The investigators plan to examine the effects of check-ins and contingency management on engagement with addiction treatment and equity of treatment effects among racial and ethnic subgroups and assess important moderators of treatment effects.
Detailed description
The investigators are proposing to conduct a randomized controlled trial to determine the effectiveness of various text-based and contingency management interventions on Opioid Use Disorder patients. Our goals are to measure their engagement with recovery treatment. The research team plan to enroll 1,649 participants into one of the following 4 arms.
Patients enrolled into the Way to Health CareConnect text line as part of usual care and meeting eligibility criteria will be enrolled in this randomized control trial and randomized to:
Augmented usual care (standard Way to HealthCareConnect text line) Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week.
Augmented usual care + text-message check-ins (standard Way to Health CareConnect Text line) Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week AND (text-message check-ins) patients will receive automated text-message check-ins up to once per day for 30 days to see if the patient needs help with anything.
Augmented usual care + contingency management (standard Way to Health CareConnect Text line) and, participants will be compensated for going to their follow-up appointments.
Augmented usual care + CM + Text-message check-ins (standard Way to Health CareConnect text line) AND text-message check-ins-patients will receive automated text-message check-ins up to once per day for 30 days to see if the patient needs help with anything AND, participants will receive compensation for attending their follow-up appointments.
Patients enrolled in the trial will also be invited to complete the intake survey and follow-up surveys. Patients will receive financial compensation for completing these surveys. The study team plans to enroll 1,649 participants for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients enrolled into the Way to Health CareConnect text line as part of usual care and meeting eligibility criteria will be enrolled in this randomized control trial and randomized to: Augmented usual care, standard Way to Health CareConnect text line Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Augmented usual care + text-message check-ins, standard Way to Health CareConnect Text line Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week AND (text-message check-ins) patients will receive automated text-message check-ins up to once per day for 30 days to see if the patient needs help with anything. Augmented usual care + contingency management (standard Way to Health CareConnect Text line) and, participants will be compensated for going to their follow-up appointments.
| Arm | Type | Receives |
|---|---|---|
| Augmented Usual Care (AUC) | No intervention | –AUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6. |
| Augmented usual care + text-message check-ins | Active comparator | Behavioral: Text Message Check-insAUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Text check-in: Patients will also receive incentives for engagement with treatment and Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6. |
| Augmented Usual care + Contingency Management (CM) | Active comparator | Behavioral: Contingency ManagementAUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6. CM: Patients will also receive incentives for engagement with treatment. |
| Augmented usual care + text-message check-ins + contingency management | Active comparator | Behavioral: Text Message Check-ins, Behavioral: Contingency ManagementAUC: Standard Way to Health Care text line. Patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. Text check-in: Patients will also receive incentives for engagement with treatment and Participants across all arms will receive an intake survey, and follow-up surveys at day 15, day 30, month 3, and month 6. CM: Patients will also receive incentives for engagement with treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be 18 or older
- Screen positive for OUD
- Bridge buprenorphine prescription (emergency department (ED) enrollment - Buprenorphine prescription at ED discharge; Bridge clinic enrollment - new buprenorphine prescription associated with on-demand or drop-in encounter
- English reading ability
- Have a mobile phone capable of receiving text messages
Key exclusion criteria (1 listed)
- Not being up to date with requirements above
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 |
|---|---|---|
| Text Message Check-insPatients will receive automated text-message check-ins up to once per day for 30 days to see if the patient needs help with anything AND patients can call or text the on-call substance use navigators (SUN) from 9a-9p, 7 days a week. | Behavioural | Augmented usual care + text-message check-ins, Augmented usual care + text-message check-ins + contingency management |
| Contingency ManagementPatients will receive incentives for engagement with treatment. Participant will receive compensation for filling their buprenorphine scripts at discharge and attending their follow-up care appointments. | Behavioural | Augmented Usual care + Contingency Management (CM), Augmented usual care + text-message check-ins + contingency management |
Primary outcome
Engagement in any addiction treatment at 30 days of randomization
Time frame: 31 days
Engagement in any addiction treatment within 30 days of randomization (measured on day 31)
2 secondary outcomes
ED and Hospital Utilization and mortality
Time frame: 6 months
Engagement in addition treatment within 14 days
Time frame: 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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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.
Kit Delgado, MD, MS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message Check-ins and Contingency Management in people with Opioid Use Disorder and Opioid Dependence With Current Use (Disorder), run by University of Pennsylvania 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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Engagement in any addiction treatment at 30 days of randomization (time frame: 31 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 13 Jul 2026.