Opioid DependenceCCODAPPNCT04121546
Collaborative Care for Opioid Dependence And Pain Pilot Study
A study testing Telecare Intervention in people with Opioid Dependence and Chronic Pain, run by Indiana University at 1 site in United States.
Trial summary
This pilot study evaluates a collaborative care program to assist with opioid tapering in patients with chronic pain. Patients will be randomized to receive the intervention or usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence, Chronic Pain
- What is being tested?
- Telecare Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2020to 30 Jun 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
- Chronic pain for at least 6 months
- Receiving daily opioid treatment
Who cannot join
- Not speaking English
- Significant psychiatric impairment including severe cognitive impairment, suicidality, schizophrenia, or bipolar disorder
- Known life expectancy of less than 6 months
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study evaluates a collaborative care program to assist with opioid tapering in patients with chronic pain. Patients will be randomized to receive the intervention or usual care.
- Conditions
- Opioid Dependence, Chronic Pain
- Being tested
- Telecare Intervention
- Medical subject headings
- Opioid-Related Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telecare InterventionBehavioural
Patients will meet with a care coordinator to discuss current opioid use pattern and potential reduction strategies. Participants will fill out baseline measures. A 6 week positive psychology intervention will also be introduced in which patients will practice different techniques each week over 6 weeks, and will then practice incorporating a single technique into daily practice for the remaining 6 weeks. During the first 6 weeks, patients will have weekly check in meetings with a care manager to report on any withdrawal symptoms. These meetings will space to ever other week during the remaining 6 weeks. Possible treatment adjustments will be discussed between the care coordinator and primary investigator at weekly meetings. At the completion of the 12 week study, patients will complete outcome measures.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Patients will receive the telecare intervention. Receives: Behavioral: Telecare Intervention |
| Usual Care Arm | No intervention | Patients will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Dose Change
Percentage change in daily opioid morphine milligram equivalent (MME) dose
Measured: 12 weeks
Secondary outcomes (1)
Change in PROMIS Pain Interference
The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference 8a is an 8-item scale from the PROMIS item bank which assesses self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Each item has a 5-point Likert response, with total scores ranging from 8 - 40, with higher numbers corresponding to worse pain interference outcomes. For this outcome, the score at baseline was subtracted from the score at 12 weeks to determine the change score, with negative change scores demonstrating symptom improvement (i.e. less pain interference).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start18 Sep 2020
- Primary completion1 Feb 2022
- Study completion30 Jun 2022
Why it stopped: Insufficient enrollment
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 DependenceStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Michael A. Bushey, Indiana University
- Investigators
- Michael A Bushey, MD, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121546
- Sponsor's protocol ID
- 1905213338
- Other IDs
- KL2TR002530
- Acronym
- CCODAPP
- Status last verified
- Feb 2024
- First submitted
- 8 Oct 2019
- Last updated
- 1 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Care for Opioid Dependence And Pain Pilot Study
- ClinicalTrials.gov ID
- NCT04121546
- Acronym / sponsor ID
- CCODAPP / 1905213338
- Conditions
- Opioid Dependence, Chronic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Posted 1 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study evaluates a collaborative care program to assist with opioid tapering in patients with chronic pain. Patients will be randomized to receive the intervention or usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Telecare InterventionPatients will receive the telecare intervention. |
| Usual Care Arm | No intervention | –Patients will receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic pain for at least 6 months
- Receiving daily opioid treatment
Key exclusion criteria (3 listed)
- Not speaking English
- Significant psychiatric impairment including severe cognitive impairment, suicidality, schizophrenia, or bipolar disorder
- Known life expectancy of less than 6 months
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 |
|---|---|---|
| Telecare InterventionPatients will meet with a care coordinator to discuss current opioid use pattern and potential reduction strategies. Participants will fill out baseline measures. A 6 week positive psychology intervention will also be introduced in which patients will practice different techniques each week over 6 weeks, and will then practice incorporating a single technique into daily practice for the remaining 6 weeks. During the first 6 weeks, patients will have weekly check in meetings with a care manager to report on any withdrawal symptoms. These meetings will space to ever other week during the remaining 6 weeks. Possible treatment adjustments will be discussed between the care coordinator and primary investigator at weekly meetings. At the completion of the 12 week study, patients will complete outcome measures. | Behavioural | Intervention Arm |
Primary outcome
Opioid Dose Change
Time frame: 12 weeks
Percentage change in daily opioid morphine milligram equivalent (MME) dose
1 secondary outcome
Change in PROMIS Pain Interference
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- 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.
Michael A Bushey, MD, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telecare Intervention in people with Opioid Dependence and Chronic Pain, run by Indiana University 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 1 Mar 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?
Yes. Results are posted in the registry (first posted 1 Mar 2024). 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?
Opioid Dose Change (time frame: 12 weeks). 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 1 Mar 2024.