Opioid Use DisorderPhase 3NCT07361432
Digital Treatment for Chronic Pain and Addiction in Veterans With Opioid Use Disorder Receiving Buprenorphine
A Phase 3 study testing Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) and Enhanced Treatment as Usual (ETAU) in people with Opioid Use Disorder and Chronic Pain, run by VA Office of Research and Development at 4 sites in United States.
Trial summary
Chronic pain is common in individuals with opioid use disorder (OUD) and the first-line treatment, Medication for OUD (MOUD), does not address the considerable functional impairments associated with chronic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Chronic Pain
- What is being tested?
- Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) and Enhanced Treatment as Usual (ETAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Nov 2026to 31 May 2030
- Phase
- Phase 3
- 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
- an ICD-11 opioid use disorder (OUD) diagnosis in the VHA electronic health record (EHR)
- receipt of buprenorphine from outpatient addiction clinic with stable (i.e., unchanged in 2 weeks or since last injection) dose confirmed by the prescribing clinician. Both oral and injectable buprenorphine formulations will be eligible with dose stabilization required to isolate chronic pain from withdrawal-related pain associated with non-therapeutic dose
- presence of musculoskeletal pain that is bothersome or high-impact per the Graded Pain Scale - Revised
- access to a web-connected device to complete daily surveys and connect to Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) treatment site
- ability to participate safely in the walking portion of the intervention as evidenced by patient-reported ability to walk at least one block
Who cannot join
- dementia-related electronic health record (EHR) diagnosis
- participant-reported vision or hearing impairments that would preclude use of the Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) system
- legal actions that would make study completion unlikely
- current or past 12 month engagement in CBT for chronic pain treatment
- planned surgical intervention for pain
- physical or mental health conditions that would interfere with ability to meaningful engage in Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) and Medication for OUD (MOUD) treatment (e.g., uncontrolled bipolar disorder, active suicidal ideation, receipt of hospice or end-of-life palliative care)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114
Erin Reilly, PhD, 781-687-4191, erin.reilly@va.gov
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
Rebekah Harris, DPT, 857-364-2785, rebekah.harris@va.gov
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
Shannon Nugent, PhD, 503-220-8262 ext. 51721, shannon.nugent@va.gov
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
R. Ross MacLean, PhD, (203) 932-5711 ext. 7423, robert.maclean@va.gov
R. Ross MacLean, PhD
About this study
Official title: Improving Pain and Functioning Using an Integrative Digital Treatment for Chronic Pain and Addiction in Veterans With Opioid Use Disorder Receiving Buprenorphine
Chronic pain is common in individuals with opioid use disorder (OUD) and the first-line treatment, Medication for OUD (MOUD), does not address the considerable functional impairments associated with chronic pain. Veterans with OUD and chronic pain could benefit from integrated, behavioral treatment for chronic pain and addiction, but VHA MOUD clinics often lack the resources to offer these services. The proposed study will examine the effectiveness of an evidence-based digital chronic pain and addiction treatment that Veterans can do from home, which can provide a flexible option for Veterans to engage in treatment from home and the Veterans Health Administration (VHA) a means to provide care without placing trained clinicians at each facility.
Read the detailed description
The Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) is a 9-week, web-based treatment supplemented with daily digital surveys that inform personalized weekly feedback messages for people with chronic pain and OUD receiving MOUD. IMPACT is an integration of two previously tested technology-based interventions developed in a prior NIH-funded trial. Typically, VHA pain treatment resources are greater than civilian healthcare settings; therefore, the comparator group (enhanced treatment as usual or ETAU) in the current trial is a necessary step to rigorously test IMPACT specifically within Veteran Health Administration (VHA) clinical care.
- Conditions
- Opioid Use Disorder, Chronic Pain
- Being tested
- Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT), Enhanced Treatment as Usual (ETAU)
- Keywords
- Buprenorphine, Chronic pain, Opioid-related disorders, Internet-based intervention, Cognitive behavioral therapy
- 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.
Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT)Behavioural
The IMPACT program is a 9-module web-based treatment augmented with personalized weekly feedback from an expert coach for people with chronic pain and OUD receiving MOUD.
Enhanced Treatment as Usual (ETAU)Behavioural
ETAU is inclusive of medication management, groups, and individual treatment offered within the outpatient buprenorphine clinics at the study sites. Additionally, study staff will provide a a comprehensive list of pain, addiction and mental health treatment options that are specific to their VA facility.
| Study group | Role | What they receive |
|---|---|---|
| IMPACT | Experimental | Data from Veteran participants randomized to digital intervention (IMPACT) Receives: Behavioral: Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) |
| ETAU | Placebo comparator | Data from Veteran participants randomized to ETAU (no access to IMPACT) Receives: Behavioral: Enhanced Treatment as Usual (ETAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Pain Interference 6b
T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower corresponds to less pain interference).
Measured: 3-months post-randomization
Secondary outcomes (7)
PROMIS Pain Interference 6b
T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower score corresponds to less pain interference).
Measured: 6- and 9-months post randomization
Veterans Rand 12-Item Health Survey (VR-12)
T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower corresponds to better quality of life).
Measured: 3-months post-randomization
Activity Measure for Post-Acute Care (AM-PAC)
Measure has two scales: Basic Mobility (range: 0-24) and Daily Activity (range: 0-24); on both scales higher scores corresponds to better performance.
Measured: 3-months post-randomization
PROMIS Sleep Disturbance 6a and Duration
T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower score corresponds to less sleep disturbance).
Measured: 3-months post randomization
Buprenorphine retention
retention is defined as both continuous and verified enrollment in MOUD in the 30 days prior to the specified timepoint. Continuous will be defined as having a continuously active buprenorphine prescription with a record of dispensing that includes the prior 30 days verified by Electronic Health Record. Retention will be a binary outcome with 1 = retained (conditions met) and 0 = not retained
Measured: 3-months post randomization
Buprenorphine adherence
Timeline Follow-back will collect days of use for buprenorphine since last time point. During treatment period, weekly Timeline Follow-back adherence to buprenorphine will be compared to daily surveys and active buprenorphine prescription will be verified in Electronic Health Record (EHR). If a participant does not complete Timeline Follow-Back and/or has missing data in daily surveys or did not pick up buprenorphine as prescribed in EHR, the week will be considered non-adherent. Injectable buprenorphine will be verified in EHR and, if participant received injection as scheduled, they will be considered adherent. Mean adherent weeks will be calculated in each group; higher number corresponds to greater adherence.
Measured: 3-months post randomization
Non-prescribed opiate use
Timeline Follow-back will collect days of non-prescribed opiate use since last time point. Weekly Timeline Follow-back non-prescribed opiate use will be collected during treatment period. Mean days of non-prescribed opiate use in a week will be calculated in each group; higher number corresponds to greater non-prescribed opiate use.
Measured: 3-months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start2 Nov 2026 (estimated)
- Primary completion3 Jun 2029 (estimated)
- Study completion31 May 2030 (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 VA Office of Research and DevelopmentThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study is a hybrid type 1 effectiveness-implementation trial of IMPACT versus ETAU to improve functioning and quality of life in Veterans with chronic pain and OUD.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- R. Ross MacLean, PhD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361432
- Sponsor's protocol ID
- RRDA-001-25M
- Other IDs
- 1I01RD000376-01A1
- Status last verified
- Sep 2026
- First submitted
- 14 Jan 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pain and Functioning Using an Integrative Digital Treatment for Chronic Pain and Addiction in Veterans With Opioid Use Disorder Receiving Buprenorphine
- ClinicalTrials.gov ID
- NCT07361432
- Acronym / sponsor ID
- RRDA-001-25M
- Conditions
- Opioid Use Disorder, Chronic Pain
- Keywords
- Buprenorphine, Chronic pain, Opioid-related disorders, Internet-based intervention, Cognitive behavioral therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 3 Jun 2029 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 23 Jan 2026 (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.
Chronic pain is common in individuals with opioid use disorder (OUD) and the first-line treatment, Medication for OUD (MOUD), does not address the considerable functional impairments associated with chronic pain. Veterans with OUD and chronic pain could benefit from integrated, behavioral treatment for chronic pain and addiction, but VHA MOUD clinics often lack the resources to offer these services. The proposed study will examine the effectiveness of an evidence-based digital chronic pain and addiction treatment that Veterans can do from home, which can provide a flexible option for Veterans to engage in treatment from home and the Veterans Health Administration (VHA) a means to provide care without placing trained clinicians at each facility.
Detailed description
The Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) is a 9-week, web-based treatment supplemented with daily digital surveys that inform personalized weekly feedback messages for people with chronic pain and OUD receiving MOUD. IMPACT is an integration of two previously tested technology-based interventions developed in a prior NIH-funded trial. Typically, VHA pain treatment resources are greater than civilian healthcare settings; therefore, the comparator group (enhanced treatment as usual or ETAU) in the current trial is a necessary step to rigorously test IMPACT specifically within Veteran Health Administration (VHA) clinical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The present study is a hybrid type 1 effectiveness-implementation trial of IMPACT versus ETAU to improve functioning and quality of life in Veterans with chronic pain and OUD.
| Arm | Type | Receives |
|---|---|---|
| IMPACT | Experimental | Behavioral: Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT)Data from Veteran participants randomized to digital intervention (IMPACT) |
| ETAU | Placebo comparator | Behavioral: Enhanced Treatment as Usual (ETAU)Data from Veteran participants randomized to ETAU (no access to IMPACT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- an ICD-11 opioid use disorder (OUD) diagnosis in the VHA electronic health record (EHR)
- receipt of buprenorphine from outpatient addiction clinic with stable (i.e., unchanged in 2 weeks or since last injection) dose confirmed by the prescribing clinician. Both oral and injectable buprenorphine formulations will be eligible with dose stabilization required to isolate chronic pain from withdrawal-related pain associated with non-therapeutic dose
- presence of musculoskeletal pain that is bothersome or high-impact per the Graded Pain Scale - Revised
- access to a web-connected device to complete daily surveys and connect to Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) treatment site
- ability to participate safely in the walking portion of the intervention as evidenced by patient-reported ability to walk at least one block
Key exclusion criteria (6 listed)
- dementia-related electronic health record (EHR) diagnosis
- participant-reported vision or hearing impairments that would preclude use of the Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) system
- legal actions that would make study completion unlikely
- current or past 12 month engagement in CBT for chronic pain treatment
- planned surgical intervention for pain
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 |
|---|---|---|
| Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT)The IMPACT program is a 9-module web-based treatment augmented with personalized weekly feedback from an expert coach for people with chronic pain and OUD receiving MOUD. | Behavioural | IMPACT |
| Enhanced Treatment as Usual (ETAU)ETAU is inclusive of medication management, groups, and individual treatment offered within the outpatient buprenorphine clinics at the study sites. Additionally, study staff will provide a a comprehensive list of pain, addiction and mental health treatment options that are specific to their VA facility. | Behavioural | ETAU |
Primary outcome
PROMIS Pain Interference 6b
Time frame: 3-months post-randomization
T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower corresponds to less pain interference).
7 secondary outcomes
PROMIS Pain Interference 6b
Time frame: 6- and 9-months post randomization
Veterans Rand 12-Item Health Survey (VR-12)
Time frame: 3-months post-randomization
Activity Measure for Post-Acute Care (AM-PAC)
Time frame: 3-months post-randomization
PROMIS Sleep Disturbance 6a and Duration
Time frame: 3-months post randomization
Buprenorphine retention
Time frame: 3-months post randomization
Buprenorphine adherence
Time frame: 3-months post randomization
Non-prescribed opiate use
Time frame: 3-months post randomization
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 17 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
R. Ross MacLean, PhD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) and Enhanced Treatment as Usual (ETAU) in people with Opioid Use Disorder and Chronic Pain, run by VA Office of Research and Development at 4 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact R. Ross MacLean, PhD ((203) 932-5711 ext. 7423, robert.maclean@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Pain Interference 6b (time frame: 3-months post-randomization). 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 Sep 2026.