Opioid Use DisorderNCT05333341
Pain Care at Home to Amplify Function (Pain CHAMP)
A study testing TCM and TCM plus COPES in people with Opioid Use Disorder and Opioid Misuse, run by Yale University at 3 sites in United States.
Trial summary
This project aims to test simultaneously the effectiveness of telemedicine and collaborative management (TCM) vs. TCM plus Cooperative Pain Education and Self-Management (COPES) on patient level outcomes and the impact of site-tailored Implementation Facilitation to work toward long term opioid therapy dose reduction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Opioid Misuse, Chronic Pain
- What is being tested?
- TCM and TCM plus COPES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jun 2023to 30 Jun 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants:
- Engaged in TCM intervention (with or without COPES)
- Providers:
- Engaged with a participating study site
Who cannot join
- Participants:
- Not engaged in TCM intervention
- Providers:
- Not engaged with a participating study site
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Eastern Colorado HCS
Aurora, Colorado, 80045
Little Rock VAMC
Little Rock, Arkansas, 72205
VA Connecticut HCS
West Haven, Connecticut, 06516
About this study
This project aims to test simultaneously the effectiveness of telemedicine and collaborative management (TCM) vs. TCM plus Cooperative Pain Education and Self-Management (COPES) on patient level outcomes and the impact of site-tailored Implementation Facilitation to work toward long term opioid therapy dose reduction. Pain CHAMP is a patient-level randomized hybrid II effectiveness-implementation trial comparing TCM vs. TCM + COPES on the primary composite outcome of pain interference and OUD/misuse symptoms.
Read the detailed description
Pain CHAMP is a patient-level randomized hybrid II effectiveness-implementation trial comparing TCM vs. TCM + COPES on the primary composite outcome of pain interference and OUD/misuse symptoms. The investigators have developed two evidence-based collaborative care interventions that use focused resources to assist primary care providers (PCPs) in meeting the two main challenges in managing care for patients on long-term opioid therapy (LTOT) with chronic pain (CP) and opioid use disorder (OUD)/misuse: 1) reassessment of LTOT and switch to medication for opioid use disorder (MOUD) as indicated and 2) ready access to evidence-based behavioral pain treatment. Both interventions are entirely virtual and thus serve the needs of many underserved populations. Telemedicine Collaborative Management (TCM) features clinical pharmacists leading LTOT reassessment and buprenorphine (BUP) initiation in consultation with a BUP-prescribing physician. The TCM model is effective in decreasing pain interference, achieving LTOT dose reduction, BUP initiation and continuation, and shows greater patient engagement than the more resource intensive Integrated Pain Team comparator arm. Cooperative Pain Education and Self-Management (COPES), a cognitive-behavioral therapy (CBT) program delivered via telehealth that improves pain interference, improves access to evidence-based behavioral pain treatment.
While TCM and COPES are established interventions, the additional value of COPES-as a behavioral CP intervention paired with the pharmacologic-focused TCM for chronic pain and LTOT misuse/OUD--has not been tested. To advance systems-level approaches to addressing co-occurring CP, LTOT and OUD/misuse, this study will make two important steps forward. First, the investigators will use a pragmatic approach and randomize at the site-level so all eligible patients will receive standard-of-care treatment. Second, the study will train PCPs in how to re-assume care of patients' post-collaborative care to maintain gains made during the intervention/s. To meet these goals, the team of investigators with expertise conducting high-impact CP and OUD research propose Pain Care at Home to Amplify Function (Pain CHAMP) a hybrid II trial to test simultaneously the effectiveness of TCM vs. TCM plus COPES on patient level outcomes and the impact of site-tailored Implementation Facilitation on successful uptake of each intervention with the following specific aims:
Aim 1: Compare the effectiveness of pharmacist-led TCM vs TCM plus COPES on the primary composite outcome of improved pain interference and opioid safety as measured by opioid misuse or opioid use disorder. As secondary outcomes, we will compare groups on alcohol use, anxiety, depression, and sleep.
Aim 2: Evaluate the effectiveness of Implementation Facilitation for TCM and COPES on Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) guided outcomes using mixed qualitative-quantitative methods.
Aim 3: Examine the cost-effectiveness of TCM plus COPES, relative to TCM, on the primary composite outcome.
This study receives support from and included in the HEAL Initiative (https://heal.nih.gov/).
- Conditions
- Opioid Use Disorder, Opioid Misuse, Chronic Pain
- Being tested
- TCM, TCM plus COPES
- 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.
TCMBehavioural
TCM care is remotely-delivered and medium-term (up to 12 months), with the objective of improving CP and OUD/misuse symptoms primarily through medication management.
TCM plus COPESBehavioural
The COPES program will augment the effectiveness of TCM alone. COPES is a 12-week, Interactive Voice Response (IVR)-facilitated program of CBT for CP and common sequelae (depressive symptoms, sleep difficulties, low physical activity). Ongoing COPES engagement will be tracked by the COPES system. The primary components of the intervention are: 1) a self-help handbook containing the rationale and instructions for using ten pain self-management skills and their corresponding weekly skill practice goals; 2) a pedometer-facilitated walking program; 3) daily, automated IVR calls to collect pain interference, sleep quality, pedometer-measured step count, and adherence to the pain coping skill practice ratings; and 4) weekly, two to four minute pre-recorded, personalized therapist messages based on participant IVR-reported data.
| Study group | Role | What they receive |
|---|---|---|
| TCM | Active comparator | TCM uses clinical pharmacists leading LTOT reassessment and, when indicated for underlying OUD, buprenorphine (BUP) initiation in consultation with a BUP-prescribing physician. Clinical pharmacists will lead LTOT reassessment and, when indicated for underlying OUD, buprenorphine (BUP) initiation in consultation with a BUP-prescribing physician. Receives: Behavioral: TCM |
| TCM plus COPES | Experimental | Participants in this arm will use TCM plus COPES that will augment the effectiveness of TCM alone. Receives: Behavioral: TCM plus COPES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving improvement in pain interference with no evidence of OUD or misuse
Proportion of participants achieving both improvement in pain interference by using ≥ 1 point improvement in pain interference as measured by the PEG-3 scale and no evidence of OUD or misuse (score 0 on TAPS-2 opioid items and medical chart review shows no evidence).
Measured: 10 months
Secondary outcomes (4)
Mean change in anxiety using the Generalized Anxiety Disorder-2 (GAD-2) questionnaire
Mean change in anxiety post intervention using GAD-2 will be assessed at Day 0 and 6 months post-intervention (10 months). Generalized Anxiety Disorder-2 questionnaire is a 2-item validated questionnaire used to screen for anxiety with a range of scores from 0-3. A score of 3 is considered positive for anxiety with lower scores indicating no or mild anxiety.
Measured: 10 months
Mean change in depression assessed using Patient Health Questionnaire-2 (PHQ-2)
Mean change in depression post intervention using PHQ-2 will be assessed at Day 0 and 6 months post-intervention (10 months). The PHQ-2 consists of the first two questions of the Patient Health Questionnaire-9 and asks about the frequency of depressed mood and anhedonia over the past two weeks. Each question is answered on a scale of 0-3 as follows: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Score ranges from 0-6, with a score of 0-2 being negative for potential major depressive disorder and a score of 3 or more being positive for potential major depressive disorder.
Measured: 10 months
Proportion of participants with high-risk alcohol use assessed using Alcohol Use Disorders Identification Test-C (AUDIT-C)
Proportion of participants with high-risk alcohol use using AUDIT-C will be assessed at 6 months post-intervention (10 months). The AUDIT-C consists of 3 questions posed to participants about consumption habits that quantifies alcohol misuse. Each question is answered on a scale of 0-4 and total scores range from 0-8. Total scores of 5 or more indicates high-risk alcohol use.
Measured: 10 months
Mean change in sleep assessed using Brief Pain Inventory (BPI) sleep item
Mean change in sleep post intervention using BPI sleep item will be assessed at Day 0 and 6 months post-intervention (10 months). The BPI rapidly assesses the severity of pain and its impact on functioning. BPI asks the participant to rate how pain interferes with daily activities. The sleep item to be used asks, "Circle the one number that describes how, during the past week, pain has interfered with your sleep", with a scale of 1 to 10, where "0" indicates "does not interfere and "10" indicates "completely interferes".
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start16 Jun 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Jun 2027 (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 Yale UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- William Becker, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333341
- Sponsor's protocol ID
- 2000031092
- Other IDs
- 1RM1DA055310-01
- Status last verified
- Jan 2026
- First submitted
- 11 Apr 2022
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A fully de-identified data set will be shared. The data shall exclude the following direct identifiers of the individual: (i) Names; (ii) Postal address information, other than town or city, State, and zip code; (iii) Telephone numbers; (iv) Fax numbers; (v) Electronic mail addresses; (vi) Social security numbers; (vii) Medical record numbers; (viii) Health plan beneficiary numbers; (ix) Account numbers; (x) Certificate/license numbers; (xi) Vehicle identifiers and serial numbers, including license plate numbers; (xii) Device identifiers and serial numbers; (xiii) Web Universal Resource Locators (URLs); (xiv) Internet Protocol (IP) address numbers; (xv) Biometric identifiers, including finger and voice prints; and (xvi) Full face photographic images and any comparable images. Additionally all dates of service and assessment will be masked.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Care at Home to Amplify Function (Pain CHAMP)
- ClinicalTrials.gov ID
- NCT05333341
- Acronym / sponsor ID
- 2000031092
- Conditions
- Opioid Use Disorder, Opioid Misuse, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Apr 2022 (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.
This project aims to test simultaneously the effectiveness of telemedicine and collaborative management (TCM) vs. TCM plus Cooperative Pain Education and Self-Management (COPES) on patient level outcomes and the impact of site-tailored Implementation Facilitation to work toward long term opioid therapy dose reduction. Pain CHAMP is a patient-level randomized hybrid II effectiveness-implementation trial comparing TCM vs. TCM + COPES on the primary composite outcome of pain interference and OUD/misuse symptoms.
Detailed description
Pain CHAMP is a patient-level randomized hybrid II effectiveness-implementation trial comparing TCM vs. TCM + COPES on the primary composite outcome of pain interference and OUD/misuse symptoms. The investigators have developed two evidence-based collaborative care interventions that use focused resources to assist primary care providers (PCPs) in meeting the two main challenges in managing care for patients on long-term opioid therapy (LTOT) with chronic pain (CP) and opioid use disorder (OUD)/misuse: 1) reassessment of LTOT and switch to medication for opioid use disorder (MOUD) as indicated and 2) ready access to evidence-based behavioral pain treatment. Both interventions are entirely virtual and thus serve the needs of many underserved populations. Telemedicine Collaborative Management (TCM) features clinical pharmacists leading LTOT reassessment and buprenorphine (BUP) initiation in consultation with a BUP-prescribing physician. The TCM model is effective in decreasing pain interference, achieving LTOT dose reduction, BUP initiation and continuation, and shows greater patient engagement than the more resource intensive Integrated Pain Team comparator arm. Cooperative Pain Education and Self-Management (COPES), a cognitive-behavioral therapy (CBT) program delivered via telehealth that improves pain interference, improves access to evidence-based behavioral pain treatment.
While TCM and COPES are established interventions, the additional value of COPES-as a behavioral CP intervention paired with the pharmacologic-focused TCM for chronic pain and LTOT misuse/OUD--has not been tested. To advance systems-level approaches to addressing co-occurring CP, LTOT and OUD/misuse, this study will make two important steps forward. First, the investigators will use a pragmatic approach and randomize at the site-level so all eligible patients will receive standard-of-care treatment. Second, the study will train PCPs in how to re-assume care of patients' post-collaborative care to maintain gains made during the intervention/s. To meet these goals, the team of investigators with expertise conducting high-impact CP and OUD research propose Pain Care at Home to Amplify Function (Pain CHAMP) a hybrid II trial to test simultaneously the effectiveness of TCM vs. TCM plus COPES on patient level outcomes and the impact of site-tailored Implementation Facilitation on successful uptake of each intervention with the following specific aims:
Aim 1: Compare the effectiveness of pharmacist-led TCM vs TCM plus COPES on the primary composite outcome of improved pain interference and opioid safety as measured by opioid misuse or opioid use disorder. As secondary outcomes, we will compare groups on alcohol use, anxiety, depression, and sleep.
Aim 2: Evaluate the effectiveness of Implementation Facilitation for TCM and COPES on Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) guided outcomes using mixed qualitative-quantitative methods.
Aim 3: Examine the cost-effectiveness of TCM plus COPES, relative to TCM, on the primary composite outcome.
This study receives support from and included in the HEAL Initiative (https://heal.nih.gov/).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM | Active comparator | Behavioral: TCMTCM uses clinical pharmacists leading LTOT reassessment and, when indicated for underlying OUD, buprenorphine (BUP) initiation in consultation with a BUP-prescribing physician. Clinical pharmacists will lead LTOT reassessment and, when indicated for underlying OUD, buprenorphine (BUP) initiation in consultation with a BUP-prescribing physician. |
| TCM plus COPES | Experimental | Behavioral: TCM plus COPESParticipants in this arm will use TCM plus COPES that will augment the effectiveness of TCM alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Engaged in TCM intervention (with or without COPES)
- Engaged with a participating study site
Key exclusion criteria (4 listed)
- Not engaged in TCM intervention
- Not engaged with a participating study site
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 |
|---|---|---|
| TCMTCM care is remotely-delivered and medium-term (up to 12 months), with the objective of improving CP and OUD/misuse symptoms primarily through medication management. | Behavioural | TCM |
| TCM plus COPESThe COPES program will augment the effectiveness of TCM alone. COPES is a 12-week, Interactive Voice Response (IVR)-facilitated program of CBT for CP and common sequelae (depressive symptoms, sleep difficulties, low physical activity). Ongoing COPES engagement will be tracked by the COPES system. The primary components of the intervention are: 1) a self-help handbook containing the rationale and instructions for using ten pain self-management skills and their corresponding weekly skill practice goals; 2) a pedometer-facilitated walking program; 3) daily, automated IVR calls to collect pain interference, sleep quality, pedometer-measured step count, and adherence to the pain coping skill practice ratings; and 4) weekly, two to four minute pre-recorded, personalized therapist messages based on participant IVR-reported data. | Behavioural | TCM plus COPES |
Primary outcome
Proportion of participants achieving improvement in pain interference with no evidence of OUD or misuse
Time frame: 10 months
Proportion of participants achieving both improvement in pain interference by using ≥ 1 point improvement in pain interference as measured by the PEG-3 scale and no evidence of OUD or misuse (score 0 on TAPS-2 opioid items and medical chart review shows no evidence).
4 secondary outcomes
Mean change in anxiety using the Generalized Anxiety Disorder-2 (GAD-2) questionnaire
Time frame: 10 months
Mean change in depression assessed using Patient Health Questionnaire-2 (PHQ-2)
Time frame: 10 months
Proportion of participants with high-risk alcohol use assessed using Alcohol Use Disorders Identification Test-C (AUDIT-C)
Time frame: 10 months
Mean change in sleep assessed using Brief Pain Inventory (BPI) sleep item
Time frame: 10 months
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 30 Jan 2026.
- Individual participant dataSharing planned: Yes. A fully de-identified data set will be shared. The data shall exclude the following direct identifiers of the individual: (i) Names; (ii) Postal address information, other than town or city, State, and zip code; (iii) Telephone numbers; (iv) Fax numbers; (v) Electronic mail addresses; (vi) Social security numbers; (vii) Medical record numbers; (viii) Health plan beneficiary numbers; (ix) Account numbers; (x) Certificate/license numbers; (xi) Vehicle identifiers and serial numbers, including license plate numbers; (xii) Device identifiers and serial numbers; (xiii) Web Universal Resource Locators (URLs); (xiv) Internet Protocol (IP) address numbers; (xv) Biometric identifiers, including finger and voice prints; and (xvi) Full face photographic images and any comparable images. Additionally all dates of service and assessment will be masked.
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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.
William Becker, MD principal investigator
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCM and TCM plus COPES in people with Opioid Use Disorder and Opioid Misuse, run by Yale University at 3 sites 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 4 inclusion and 4 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 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Proportion of participants achieving improvement in pain interference with no evidence of OUD or misuse (time frame: 10 months). 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 30 Jan 2026.