Opioid Use DisorderiENDURENCT03842384
Digital Health Intervention to Support Opioid Use Disorder Treatment
A study testing iENDURE in people with Opioid Use Disorder and Treatment Adherence, run by Rhode Island Hospital at 1 site in United States.
Trial summary
In prior studies, the investigative team developed a combined computer- and text message-delivered personalized-feedback intervention (iENDURE) designed to enhance motivation and improve tolerance of distress to support the early phase of buprenorphine 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, Treatment Adherence
- What is being tested?
- iENDURE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 15 Nov 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18+ years; current DSM-5 diagnosis of Opioid Use Disorder; current buprenorphine prescription; and access to cell phone with text message capability.
Who cannot join
- active suicidality and/or psychosis; not fluent in English; not having a phone data plan.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: iENDURE: Digital Health Intervention to Support Opioid Use Disorder Treatment
In prior studies, the investigative team developed a combined computer- and text message-delivered personalized-feedback intervention (iENDURE) designed to enhance motivation and improve tolerance of distress to support the early phase of buprenorphine treatment. Specific aims of this subsequent study include conducting a preliminary randomized controlled trial with 80 participants to examine the efficacy of iENDURE relative to Treatment-as-Usual (TAU).
Read the detailed description
Medication for Opioid Use Disorder (MOUD), which includes the use of Methadone, Buprenorphine, or long-acting Naltrexone, is an evidence-based approach to the treatment of Opioid Use Disorder. Buprenorphine, a partial opioid agonist, has grown in popularity over the last decade because of its safety profile and flexible administration. Despite its advantages, nearly half of participants are unable to achieve stabilization, and many discontinue treatment or return to illicit opioid use. Given high rates of noncompliance and/or dropout, there have been recent calls to find innovative interventions to enhance motivation, adherence, and retention in MOUD. Distress tolerance (DT), the perceived or actual ability to handle aversive physical or emotional states, is a transdiagnostic vulnerability factor implicated in the development and maintenance of affective symptoms/disorders and substance use. Preliminary work suggests that targeting DT during treatment may improve outcomes, by promoting the ability to persist in goal directed activity (e.g., abstinence) even when experiencing distress. Accordingly, an intervention that cultivates motivation for abstinence above the reinforcing effects of opioids and teaches adaptive distress tolerance strategies may optimize the induction and stabilization phases of buprenorphine treatment to improve long-term recovery. Personalized-feedback interventions, such as decisional balance feedback evaluating the advantages/disadvantages of engaging in a certain behavior, represent a promising method to enhance engagement in buprenorphine treatment. Digital health interventions have the capability of reaching a variety of patient populations and are well-suited to offer support, skills training, and reminders during times of increased distress that occur in 'real-time' outside of structured treatment settings. The objective of this study is to test the preliminary efficacy of a combined computer- and text message-delivered intervention for adults initiating buprenorphine treatment for opioid use disorder.
Following consent procedures, all participants will complete a brief online survey and then be randomly assigned to receive either (a) iENDURE, a computer- and text message-delivered intervention, or (b) treatment-as-usual and no additional intervention. All participants, regardless of treatment group, will complete a second set of questionnaires following randomization. All participants will also be scheduled for follow-up assessments at 1-, 4-, 8- and 12-weeks. Participants assigned to treatment-as-usual will engage in care as determined by their treatment team. Participants randomized to the iENDURE group will also engage in routine clinical care, however, they will additionally complete a brief computer intervention introducing designed to enhance motivation through a decisional balance exercise and improve tolerance of distress through skills training. Information obtained in the computer intervention will be used to personalize the subsequent text message portion of the intervention. Participants will receive 8 weeks of personalized text messages that will a) remind of salient motivational factors, and b) provide recommendations for relevant distress tolerance skills. Finally, participants in the iENDURE treatment condition will be asked to complete a individual qualitative interview at the conclusion of the intervention to elicit feedback for further improvement and refinement of the iENDURE program.
- Conditions
- Opioid Use Disorder, Treatment Adherence
- Being tested
- iENDURE
- Keywords
- Buprenorphine, Digital Health, Medication for Opioid Use Disorder
- Medical subject headings
- Opioid-Related Disorders, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iENDUREBehavioural
The proposed intervention will initially target motivational processes in combination with introductory strategies for managing physical and emotional distress through a single, brief, computer-delivered session followed by eight weeks of theoretically-informed text messages intended to enhance motivation and promote distress tolerance.
| Study group | Role | What they receive |
|---|---|---|
| iENDURE | Experimental | iENDURE involves two delivery modes: computer and text message. The intervention initially targets motivational processes in combination with introductory strategies for managing physical and emotional distress through a single, brief, computer-delivered session followed by eight weeks of theoretically-informed text messages intended to enhance motivation and promote distress tolerance (DT). Receives: Behavioral: iENDURE |
| Treatment-as-Usual | No intervention | Participants in the TAU comparison control group will engage in buprenorphine treatment as determined by their clinical team. This could include medication evaluations, individual or group counseling, case management or peer recovery. TAU was selected as the comparison condition as it represents a robust and evidence-based approach to the treatment of OUD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Buprenorphine Adherence
The Timeline Follow-Back will be used to collect self-report data on daily buprenorphine adherence. Adherence is recorded as either 0 (prescribed dose not taken) or 1 (prescribed dose taken). Buprenorphine adherence will be operationalized as the percentage of days positive for buprenorphine administration.
Measured: Participants will be asked to report on daily use up to 1-, 4-, 8- and 12- week following medication induction.
Self-Reported Illicit Substance Use
The Timeline Follow-Back will be used to collect self-report data on daily illicit substance use. Illicit substance use will be recorded as either 0 (no illicit substance use) or 1 (illicit substance use). Illicit substance use will be operationalized as the percentage of days positive for drug use (separate by drug class).
Measured: Participants will be asked to report on daily use up to 1-, 4-, 8- and 12- week following medication induction.
Biochemically Verified Buprenorphine Adherence
Urine samples will be collected and tested to confirm adherence to buprenorphine. A 5 ng/mL urine buprenorphine cutoff will be indicative of compliance with buprenorphine treatment.
Measured: Performed at 1-, 4-, 8- and 12- week following medication induction.
Biochemically Verified Illicit Substance Use
Urine samples will be collected and tested to confirm or deny use of other illicit substances.
Measured: Performed at 1-, 4-, 8- and 12- week following medication induction.
Secondary outcomes (3)
Readiness Ruler
Brief assessment of a person's present motivational state relative to changing a specific behavior. In this study, the Readiness Ruler will assess participants' motivation to change use of illicit opioids. The ruler is based upon a likert scale ranging from 1 (Definitely NOT Ready to Change) to 10 (Definitely Ready to Change). Higher scores reflect greater motivation to change.
Measured: 1-, 4-, 8-, and 12-weeks post medication induction.
Confidence Scale
This item assesses participant's confidence in meeting their recovery goals. Participants are prompted "Please indicate to what extent you feel confident in reaching your goals for treatment" and were expected to respond on a 11-point Likert scale, ranging from "0" = "I do not think I will reach my goals" and "10" = "I think I will definitely reach my goals". Higher score indicated greater levels of confidence in meeting goals.
Measured: 1-, 4-, 8-, and 12-weeks post medication induction.
Distress Tolerance Scale
The Distress Tolerance Scale is a 15-item self-report measure in which respondents indicate, on a 5-point Likert-type scale (1 = strongly agree to 5 = strongly disagree), the extent to which they can experience and withstand distressing psychological states. Higher total scores reflect greater ability to tolerate distress. The total score is computed as a mean, with a possible range of 1-5.
Measured: 1-, 4-, 8-, and 12-weeks post medication induction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Oct 2020
- Primary completion7 Aug 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kirsten J Langdon, PhD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842384
- Sponsor's protocol ID
- K23DA046482
- Other IDs
- K23DA046482
- Acronym
- iENDURE
- Status last verified
- Mar 2023
- First submitted
- 11 Feb 2019
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langdon KJ, Ramsey S, Scherzer C, Carey K, Ranney ML, Rich J. Development of an integrated digital health intervention to promote engagement in and adherence to medication for opioid use disorder. Addict Sci Clin Pract. 2020 Apr 29;15(1):16. doi: 10.1186/s13722-020-00189-4.
PubMed 32349790
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iENDURE: Digital Health Intervention to Support Opioid Use Disorder Treatment
- ClinicalTrials.gov ID
- NCT03842384
- Acronym / sponsor ID
- iENDURE / K23DA046482
- Conditions
- Opioid Use Disorder, Treatment Adherence
- Keywords
- Buprenorphine, Digital Health, Medication for Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 15 Feb 2019 (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.
In prior studies, the investigative team developed a combined computer- and text message-delivered personalized-feedback intervention (iENDURE) designed to enhance motivation and improve tolerance of distress to support the early phase of buprenorphine treatment. Specific aims of this subsequent study include conducting a preliminary randomized controlled trial with 80 participants to examine the efficacy of iENDURE relative to Treatment-as-Usual (TAU).
Detailed description
Medication for Opioid Use Disorder (MOUD), which includes the use of Methadone, Buprenorphine, or long-acting Naltrexone, is an evidence-based approach to the treatment of Opioid Use Disorder. Buprenorphine, a partial opioid agonist, has grown in popularity over the last decade because of its safety profile and flexible administration. Despite its advantages, nearly half of participants are unable to achieve stabilization, and many discontinue treatment or return to illicit opioid use. Given high rates of noncompliance and/or dropout, there have been recent calls to find innovative interventions to enhance motivation, adherence, and retention in MOUD. Distress tolerance (DT), the perceived or actual ability to handle aversive physical or emotional states, is a transdiagnostic vulnerability factor implicated in the development and maintenance of affective symptoms/disorders and substance use. Preliminary work suggests that targeting DT during treatment may improve outcomes, by promoting the ability to persist in goal directed activity (e.g., abstinence) even when experiencing distress. Accordingly, an intervention that cultivates motivation for abstinence above the reinforcing effects of opioids and teaches adaptive distress tolerance strategies may optimize the induction and stabilization phases of buprenorphine treatment to improve long-term recovery. Personalized-feedback interventions, such as decisional balance feedback evaluating the advantages/disadvantages of engaging in a certain behavior, represent a promising method to enhance engagement in buprenorphine treatment. Digital health interventions have the capability of reaching a variety of patient populations and are well-suited to offer support, skills training, and reminders during times of increased distress that occur in 'real-time' outside of structured treatment settings. The objective of this study is to test the preliminary efficacy of a combined computer- and text message-delivered intervention for adults initiating buprenorphine treatment for opioid use disorder.
Following consent procedures, all participants will complete a brief online survey and then be randomly assigned to receive either (a) iENDURE, a computer- and text message-delivered intervention, or (b) treatment-as-usual and no additional intervention. All participants, regardless of treatment group, will complete a second set of questionnaires following randomization. All participants will also be scheduled for follow-up assessments at 1-, 4-, 8- and 12-weeks. Participants assigned to treatment-as-usual will engage in care as determined by their treatment team. Participants randomized to the iENDURE group will also engage in routine clinical care, however, they will additionally complete a brief computer intervention introducing designed to enhance motivation through a decisional balance exercise and improve tolerance of distress through skills training. Information obtained in the computer intervention will be used to personalize the subsequent text message portion of the intervention. Participants will receive 8 weeks of personalized text messages that will a) remind of salient motivational factors, and b) provide recommendations for relevant distress tolerance skills. Finally, participants in the iENDURE treatment condition will be asked to complete a individual qualitative interview at the conclusion of the intervention to elicit feedback for further improvement and refinement of the iENDURE program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iENDURE | Experimental | Behavioral: iENDUREiENDURE involves two delivery modes: computer and text message. The intervention initially targets motivational processes in combination with introductory strategies for managing physical and emotional distress through a single, brief, computer-delivered session followed by eight weeks of theoretically-informed text messages intended to enhance motivation and promote distress tolerance (DT). |
| Treatment-as-Usual | No intervention | –Participants in the TAU comparison control group will engage in buprenorphine treatment as determined by their clinical team. This could include medication evaluations, individual or group counseling, case management or peer recovery. TAU was selected as the comparison condition as it represents a robust and evidence-based approach to the treatment of OUD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 18+ years; current DSM-5 diagnosis of Opioid Use Disorder; current buprenorphine prescription; and access to cell phone with text message capability.
Key exclusion criteria (1 listed)
- active suicidality and/or psychosis; not fluent in English; not having a phone data plan.
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 |
|---|---|---|
| iENDUREThe proposed intervention will initially target motivational processes in combination with introductory strategies for managing physical and emotional distress through a single, brief, computer-delivered session followed by eight weeks of theoretically-informed text messages intended to enhance motivation and promote distress tolerance. | Behavioural | iENDURE |
Primary outcome
Self-Reported Buprenorphine Adherence
Time frame: Participants will be asked to report on daily use up to 1-, 4-, 8- and 12- week following medication induction.
The Timeline Follow-Back will be used to collect self-report data on daily buprenorphine adherence. Adherence is recorded as either 0 (prescribed dose not taken) or 1 (prescribed dose taken). Buprenorphine adherence will be operationalized as the percentage of days positive for buprenorphine administration.
Self-Reported Illicit Substance Use
Time frame: Participants will be asked to report on daily use up to 1-, 4-, 8- and 12- week following medication induction.
The Timeline Follow-Back will be used to collect self-report data on daily illicit substance use. Illicit substance use will be recorded as either 0 (no illicit substance use) or 1 (illicit substance use). Illicit substance use will be operationalized as the percentage of days positive for drug use (separate by drug class).
Biochemically Verified Buprenorphine Adherence
Time frame: Performed at 1-, 4-, 8- and 12- week following medication induction.
Urine samples will be collected and tested to confirm adherence to buprenorphine. A 5 ng/mL urine buprenorphine cutoff will be indicative of compliance with buprenorphine treatment.
Biochemically Verified Illicit Substance Use
Time frame: Performed at 1-, 4-, 8- and 12- week following medication induction.
Urine samples will be collected and tested to confirm or deny use of other illicit substances.
3 secondary outcomes
Readiness Ruler
Time frame: 1-, 4-, 8-, and 12-weeks post medication induction.
Confidence Scale
Time frame: 1-, 4-, 8-, and 12-weeks post medication induction.
Distress Tolerance Scale
Time frame: 1-, 4-, 8-, and 12-weeks post medication induction.
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 10 Apr 2024.
- Derived from this study: PubMed 32349790Langdon KJ, Ramsey S, Scherzer C, Carey K, Ranney ML, Rich J. Development of an integrated digital health intervention to promote engagement in and adherence to medication for opioid use disorder. Addict Sci Clin Pract. 2020 Apr 29;15(1):16. doi: 10.1186/s13722-020-00189-4.
- Individual participant dataSharing planned: No
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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.
Kirsten J Langdon, PhD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iENDURE in people with Opioid Use Disorder and Treatment Adherence, run by Rhode Island Hospital 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 1 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: finished, as of the sponsor's last update on 10 Apr 2024. 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?
Self-Reported Buprenorphine Adherence (time frame: Participants will be asked to report on daily use up to 1-, 4-, 8- and 12- week following medication induction.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03842384, which also lists 1 linked publication.
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 10 Apr 2024.