Opioid Use DisorderNCT04669249
Reward-Based Recovery Outcomes Management for Opioid Use Disorder
A study testing PROCare in people with Opioid Use Disorder, run by Medical Decision Logic, Inc. at 1 site in United States.
Trial summary
A randomized pilot study assessing feasibility, acceptability, and preliminary effectiveness of a reward-based recovery management platform (PROCare) designed to enhance participation in outcomes monitoring, engagement in treatment care, and adherence to medication for opioid use disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- PROCare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 29 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- access to internet-enabled smartphone device
- primary DSM-5 opioid use disorder diagnosis
- receiving medication treatment for opioid use disorder with buprenorphine
- English language proficient
Who cannot join
- active suicidal ideation or psychotic symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
South Florida Behavioral Health Network, Inc.
Miami, Florida, 33126
About this study
Official title: PROCare: Cloud Process Support for Opioid Recovery Participation and Learning
A randomized pilot study assessing feasibility, acceptability, and preliminary effectiveness of a reward-based recovery management platform (PROCare) designed to enhance participation in outcomes monitoring, engagement in treatment care, and adherence to medication for opioid use disorder.
- Conditions
- Opioid Use Disorder
- Being tested
- PROCare
- 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.
PROCareBehavioural
PROCare is a reward-based digital recovery management platform for individuals receiving medication treatment for opioid use disorder. Patients have the opportunity to earn both non-monetary and monetary incentives via smart debit card for a variety of clinically-indicated behaviors, including taking their medication (buprenorphine) as directed, attending clinic appointments and community-based mutual-help support group meetings, participating in routine outcomes monitoring surveys using validated measures, accessing the curated psychoeducation content library, and engaging in other recovery-oriented activities within the smartphone app.
| Study group | Role | What they receive |
|---|---|---|
| PROCare | Experimental | Technology-enabled, reward-based recovery platform Receives: Behavioral: PROCare |
| Control | No intervention | Treatment-as-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Fully-Adherent to Buprenorphine
Assessed by % of participants fully-adherent to daily doses during study period with higher values indicating greater buprenorphine adherence.
Measured: 4-week
Percentage of Participants Fully-Adherent to Care Plan
Assessed by % of participants fully-adherent to weekly outpatient individual therapy visits, community-based mutual-help recovery support meetings, and other scheduled appointments attended during study period with higher values indicating greater care plan adherence.
Measured: 4-week
Percentage of Participants Completing Outcomes Monitoring Surveys
Assessed by % of participants completing assessment surveys during study period with higher values indicating greater survey participation.
Measured: 4-week
Secondary outcomes (7)
Percentage of Participants Using Opioids
Assessed by participant self-report and positive urine drug screens completed at routine clinic visits during study period.
Measured: 4-week
Percentage of Participants Using Other Substances (Non-opioids)
Assessed by participant self-report and positive urine drug screens completed at routine clinic visits during study period for non-opioids substances (alcohol, cannabis, methamphetamine, amphetamines, cocaine, benzodiazepines).
Measured: 4-week
Change in Quality of Life as Assessed by EUROHIS-QOL 8-item Index From Baseline to 4-Week Follow-up
The EUROHIS-QOL (European Health Interview Survey-Quality of Life) 8-item index is an efficient, valid, and reliable measure of four quality of life domains (physical, psychological, environmental, and social). Items are rated on a 5-point Likert-type scale and summed to produce a total quality of life score (Range: 8-40) with higher scores indicating a higher level of satisfaction with their current quality of life. Change in scores from baseline to 4-week follow-up was examined with a higher change score indicating a greater increase in participant quality of life.
Measured: 4-week
Change in Opioid Craving as Assessed by Opioid Craving Scale (OCS) From Baseline to 4-Week Follow-up
OCS is a 3-item measure of opioid craving with acceptable internal consistency, reliability, and concurrent/predictive validity. Participants rate their level of craving in reference to three situations (current, past week, and high-risk environment) on a scale ranging from 0-10 to produce a total score ranging from 0-30 with higher scores indicating greater reduction in craving. Change in OCS scores from baseline to 4-week follow-up was examined to determine reductions in craving.
Measured: 4-week
Motivation as Assessed by Readiness Ruler
Readiness Ruler is a valid and reliable 2-item measure of motivation and readiness to change. Participants rate their perceived "Importance" of making a change to their drug use behaviors, and their perceived "Confidence" in their ability to successfully achieve their goal (range: 0-100) with higher scores indicating greater motivation. Perceived "Importance" and "Confidence" scores are averaged to indicate a total Motivation score at 4-week follow-up (Range: 0-100).
Measured: 4-week
Change in Self-Efficacy as Assessed by Brief Situational Confidence Questionnaire (BSCQ) From Baseline to 4-Week Follow-up
BSCQ is an 8-item measure of self-efficacy for resisting the urge to use drugs in 8 high-risk situations based on the relapse prevention model (unpleasant emotions, physical discomfort, pleasant emotions, testing control, urges/temptations, interpersonal conflict, social pressure, and pleasant times with others). Patients rate their confidence in resisting the urge to use drugs in each of the 8 situations on a scale ranging from 0 (Not at all Confident) to 100 (Extremely Confident). Scores for each of the 8 situations are averaged to produce a total self-efficacy score (Range: 0-100). Change in scores from baseline to 4-week follow-up was examined with higher scores indicating a greater increase in self-efficacy.
Measured: 4-week
Change in Opioid Use Disorder Impairment From Baseline to 4-Week Follow-up
Participant self-report will be used to determine frequency counts of the 11 opioid use disorder diagnostic criteria per Diagnostic \& Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with higher counts indicating a greater number of symptoms/opioid-related impairment present and higher opioid use disorder severity. Total score indicating the total number of positive diagnostic criteria ranges from 0-11. Change in the number of diagnostic criteria endorsed from baseline to 4-week follow-up was examined to determine reduction in opioid-related impairment with higher scores indicating a greater reduction in symptoms over time.
Measured: 4-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Mar 2022
- Primary completion29 Sep 2022
- Study completion29 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Decision Logic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRO Health Group, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Steven L Proctor, PhD, Principal investigator, PRO Health GroupAllen Tien, MD, Principal investigator, Medical Decision Logic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669249
- Sponsor's protocol ID
- 2020-001
- Other IDs
- 1R43DA051298-01A1
- Status last verified
- Nov 2022
- First submitted
- 19 Nov 2020
- Last updated
- 17 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROCare: Cloud Process Support for Opioid Recovery Participation and Learning
- ClinicalTrials.gov ID
- NCT04669249
- Acronym / sponsor ID
- 2020-001
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Medical Decision Logic, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PRO Health Group, National Institute on Drug Abuse (NIDA)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 29 Sep 2022 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Posted 17 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized pilot study assessing feasibility, acceptability, and preliminary effectiveness of a reward-based recovery management platform (PROCare) designed to enhance participation in outcomes monitoring, engagement in treatment care, and adherence to medication for opioid use disorder.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROCare | Experimental | Behavioral: PROCareTechnology-enabled, reward-based recovery platform |
| Control | No intervention | –Treatment-as-Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- access to internet-enabled smartphone device
- primary DSM-5 opioid use disorder diagnosis
- receiving medication treatment for opioid use disorder with buprenorphine
- English language proficient
Key exclusion criteria (1 listed)
- active suicidal ideation or psychotic symptoms
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 |
|---|---|---|
| PROCarePROCare is a reward-based digital recovery management platform for individuals receiving medication treatment for opioid use disorder. Patients have the opportunity to earn both non-monetary and monetary incentives via smart debit card for a variety of clinically-indicated behaviors, including taking their medication (buprenorphine) as directed, attending clinic appointments and community-based mutual-help support group meetings, participating in routine outcomes monitoring surveys using validated measures, accessing the curated psychoeducation content library, and engaging in other recovery-oriented activities within the smartphone app. | Behavioural | PROCare |
Primary outcome
Percentage of Participants Fully-Adherent to Buprenorphine
Time frame: 4-week
Assessed by % of participants fully-adherent to daily doses during study period with higher values indicating greater buprenorphine adherence.
Percentage of Participants Fully-Adherent to Care Plan
Time frame: 4-week
Assessed by % of participants fully-adherent to weekly outpatient individual therapy visits, community-based mutual-help recovery support meetings, and other scheduled appointments attended during study period with higher values indicating greater care plan adherence.
Percentage of Participants Completing Outcomes Monitoring Surveys
Time frame: 4-week
Assessed by % of participants completing assessment surveys during study period with higher values indicating greater survey participation.
7 secondary outcomes
Percentage of Participants Using Opioids
Time frame: 4-week
Percentage of Participants Using Other Substances (Non-opioids)
Time frame: 4-week
Change in Quality of Life as Assessed by EUROHIS-QOL 8-item Index From Baseline to 4-Week Follow-up
Time frame: 4-week
Change in Opioid Craving as Assessed by Opioid Craving Scale (OCS) From Baseline to 4-Week Follow-up
Time frame: 4-week
Motivation as Assessed by Readiness Ruler
Time frame: 4-week
Change in Self-Efficacy as Assessed by Brief Situational Confidence Questionnaire (BSCQ) From Baseline to 4-Week Follow-up
Time frame: 4-week
Change in Opioid Use Disorder Impairment From Baseline to 4-Week Follow-up
Time frame: 4-week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Steven L Proctor, PhD principal investigator
PRO Health Group
Allen Tien, MD principal investigator
Medical Decision Logic, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROCare in people with Opioid Use Disorder, run by Medical Decision Logic, Inc. 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: finished, as of the sponsor's last update on 17 Mar 2023. 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?
Yes. Results are posted in the registry (first posted 17 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Fully-Adherent to Buprenorphine (time frame: 4-week). The study lists 3 primary outcomes in all. 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 17 Mar 2023.