Opioid Use DisorderHOPENCT05571917
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
A study testing Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP) in people with Opioid Use Disorder and Chronic Pain, run by University of New Mexico at 2 sites in United States.
Trial summary
This study is a multisite randomized clinical trial of a treatment designed to reduce pain interference while simultaneously addressing relapse prevention among individuals who have co-occurring chronic pain and Opioid Use Disorder (OUD). 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?
- Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 May 2023to 31 Dec 2026
- 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
- Stabilized on a dose of buprenorphine for a period of at least 1 month. Buprenorphine stabilization will be defined as a consistent dose for at least 30 consecutive days.
- Willing to comply with all study procedures and be available for the duration of the study.
- Aged 18 years or older.
- Enrolled as a patient in one of the participating clinics.
- Presence of chronic pain for > 6 months in duration.
Who cannot join
- Current or past diagnosis of schizophrenia, delusional disorder, psychotic or dissociative disorders.
- Unable to read English.
- Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Integrative Treatment for Achieving Holistic Recovery From Comorbid Chronic Pain and Opioid Use Disorder
This study is a multisite randomized clinical trial of a treatment designed to reduce pain interference while simultaneously addressing relapse prevention among individuals who have co-occurring chronic pain and Opioid Use Disorder (OUD). This study will recruit approximately 160 individuals who are currently being treated in clinics specializing in the physician management of OUD. To increase generalizability of study findings and increase internal validity of the physician management component of treatment, all participants will be stabilized on buprenorphine for OUD as part of their usual clinical care. Individuals will be randomized to either: (1) enhanced usual care or (2) the integrated ACT + MBRP treatment. The investigators hypothesize that: (1) the combination of ACT + MBRP in buprenorphine-prescribed patients with chronic pain will be more efficacious across primary and secondary outcome measures in comparison to Enhanced Usual Care and (2) examination of treatment mechanism data will indicate treatment-related changes that are consistent with the theoretical models of ACT+MBRP.
Read the detailed description
Opioid prescription in the treatment of chronic pain is frequent and carries a consequent risk of poor treatment outcome, as well as higher morbidity and mortality in a clinically significant number of patients, particularly those who meet criteria for OUD. Despite the alarming increases in opioid misuse and OUD nationally, there are few treatment options available that target both pain-related interference and OUD in an integrated fashion among patients with chronic pain. To date, there are no evidence-based treatment options that aim to minimize pain interference while simultaneously addressing OUD among individuals with medication prescribed for OUD.
The present trial builds upon a pilot study that tested the feasibility of integrating two empirically-supported psychosocial interventions, ACT to reduce pain interference and MBRP to reduce opioid misuse. Following successful integration of the interventions, outcome analyses found that the integrated ACT + MBRP intervention reduced both pain interference and opioid misuse at a 6-month follow-up in comparison to physician management alone.
This study is a multisite randomized clinical trial that will recruit approximately 160 individuals who are currently being treated in clinics specializing in the physician management of OUD. To increase generalizability of study findings and increase internal validity of the physician management component of treatment, all participants will be stabilized on buprenorphine for OUD as part of their usual clinical care. Individuals will be randomized to either: (1) enhanced usual care or (2) the integrated ACT + MBRP treatment.
The primary outcome, pain interference, will be assessed at the end of the active treatment phase and at 6- and 12-month follow-ups. Secondary outcomes will include pain intensity, depression, and pain-related fear, and an exploratory outcome of self-report of substance use with urine testing for confirmation. Treatment mechanism variables, including chronic pain acceptance, engagement in values-based action, and opioid craving will be assessed weekly during the active phase of treatment.
Our overall hypotheses are that: (1) the combination of ACT + MBRP in buprenorphine-prescribed patients with chronic pain will be more efficacious across primary and secondary outcome measures in comparison to EUC and (2) examination of treatment mechanism data will indicate treatment-related changes that are consistent with the theoretical models of ACT+MBRP.
- Conditions
- Opioid Use Disorder, Chronic Pain
- Being tested
- Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP), Enhance Usual Care (EUC)
- 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.
Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP)Behavioural
This intervention is an integrated psychosocial treatment of two established treatments for chronic pain and Opioid Use Disorder (OUD). This intervention focuses on reducing pain interference and preventing relapse to opioid misuse.
Enhance Usual Care (EUC)Behavioural
This intervention consists of psychoeducational materials about chronic pain treatment resources, signs and management of opioid overdose and overdose prevention. This intervention also consists of a brief, remote visit with a study therapist, lasting approximately 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| ACT + MBRP Intervention | Experimental | The ACT + MBRP group will follow a manualized clinical protocol. Treatment will include 12 weekly, virtual group-based sessions, each lasting 90 minutes. Group sizes will range from three to ten participants. All sessions will be audio recorded for fidelity. Over the course of the group meetings, participants identify areas of meaningful functioning that have been adversely impacted by pain, learn methods to enhance pain willingness in the service of these meaningful areas, and practice present-focused awareness skills. Group sessions include discussions of the impact of pain and distress avoidance, identifying alternatives to this avoidance and establishing plans for behavior change, demonstration and role-playing exercises, and homework assignments. Participants are provided with a treatment manual to help guide and inform practice outside of group sessions. Receives: Behavioral: Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP) |
| Enhanced Usual Care (EUC) | Active comparator | The Enhanced Usual Care (EUC) condition will supplement standard practices within the study sites related to chronic pain and OUD education. Participants randomized to the EUC condition will receive a brochure (in-person, via email, or via text message) with a list of chronic pain treatment resources, signs and management of opioid overdose including naloxone, and overdose prevention, and will encouraged to schedule an appointment with a clinical provider if they would like to discuss any current or past symptoms. In addition to receiving the brochure, EUC condition participants will meet with a therapist remotely for approximately 15 minutes for a descriptive overview of the brochure. In this session, the therapist will point out the resources in the brochure and read the helpful tips out loud to the participant. This session will be audio recorded for fidelity. Receives: Behavioral: Enhance Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Interference
Pain interference between participants randomized to ACT+MBRP vs EUC assessed by Pain interference will be measured via Patient Reported Outcome Measurement Information System (PROMIS) Bank v1.0 Pain Interference: The National Institutes of Health (NIH) PROMIS toolkit measure for pain interference. Each item ranges from 0 (not at all) to 5 (very much interfered) and higher scores reflect more severe pain interference. This questionnaire asks about pain interference in the past 7 days (collected once at baseline, post-treatment, and months 6 and 12).
Measured: Change from baseline through 12-month follow-up period
Secondary outcomes (6)
Change in Pain Intensity
Pain intensity between participants randomized to ACT+MBRP vs EUC will be measured via the PROMIS Short Form (SF) Pain Intensity 1a of the Helping to End Addiction Long-Term (HEAL) Initiative. Pain intensity will be assessed via a 0 (no pain) to 10 (maximum possible pain) scale for the previous week (collected once at baseline, post-treatment, and months 6 and 12). Higher scores reflect more severe pain intensity.
Measured: Change from baseline through 12-month follow-up period
Change in Depression
Depression symptoms between participants randomized to ACT+MBRP vs EUC will be measured via the Patient Health Questionnaire 9 (PHQ-9). The PHQ-9 will be used to assess depression symptoms via 9 self-report items. Response options on the PHQ9 range from 1 (not at all) to 4 (nearly every day) for frequency of depression symptoms in the previous 2 weeks (collected once at baseline, post-treatment, and months 6 and 12). Higher scores indicate more severe depression symptoms.
Measured: Change from baseline through 12-month follow-up period
Change in Pain-Related Anxiety
Pain-related anxiety between participants randomized to ACT+MBRP vs EUC will be measured via the Pain Anxiety Symptom Scale (PASS). Response options on the PASS range from 1 (never) to 5 (always) for frequency of pain-related anxiety in the previous 7 days (collected once at baseline, post-treatment, and months 6 and 12). Higher scores indicate more severe pain-related anxiety.
Measured: Change from baseline through 12-month follow-up period
Change in Pain Acceptance
Pain acceptance between participants randomized to ACT+MBRP vs EUC will be measured via the Chronic Pain Acceptance Questionnaire (CPAQ). The CPAQ assesses how often a given statement is true for the participant; response options range from a 0 (never true) to 6 (always true) with some items reverse scored. Higher scores indicate better pain acceptance. The CPAQ will be administered once at baseline, weekly during the intervention period, monthly during the intervention period, post-treatment, and months 6 and 12.
Measured: Change from baseline through 12-week treatment period and 12-month follow-up period
Change in Valued-Action
Valued-actions between participants randomized to ACT+MBRP vs EUC will be measured via the Values Tracker (VT) to assess how effective the participant was within the previous week in engaging in actions or activities that align with their personal values. The VT will be administered once at baseline, weekly during the intervention period, monthly during the intervention period, post-treatment, and months 6 and 12. Responses are measured via a slider ranging from 1 (not at all) to 10 (most effective). Higher scores reflect better valued-action engagement.
Measured: Change from baseline through 12-week treatment period and 12-month follow-up period
Change in Craving
Opioid craving between participants randomized to ACT+MBRP vs EUC will be measured via a modified version of the Penn Alcohol Craving Scale (PACS) where opioid-related cravings are assessed instead of alcohol-related cravings. Responses range from 0 to 6 where 0 represents the absence of the specific craving symptom in the item, and 6 represents the maximum intensity or frequency of the craving symptom in the item. Higher scores on the PACS reflect more severe opioid craving. Craving symptoms are assessed for the previous week (once at baseline, weekly during the intervention period, monthly during the intervention period, post-treatment, and months 6 and 12).
Measured: Change from baseline through 12-week treatment period and 12-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start5 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Model description
- A research coordinator who is not involved in the intervention phases of the study will randomize individuals to study arm. A block randomization method stratified by site and gender will be used with a random block size based on group scheduling, where groups will start with a group size of three to ten participants. The coordinator will generate a randomization list prior to the implementation phase. To further maintain masking, a research assistant who is not involved in the intervention phases of the study will administer all assessment measures.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Wake Forest University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Katie A Witkiewitz, University of New Mexico
- Investigators
- Katie Witkiewitz, PhD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571917
- Sponsor's protocol ID
- 2206006784
- Other IDs
- RM1DA055301
- Acronym
- HOPE
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2022
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All applicable NIH Data Sharing Policies: See https://grants.nih.gov/policy/sharing.htm for policies and resources. The investigators will comply with all NIH HEAL Initiative Data Sharing policies established during the project period. This includes compliance with the NIH HEAL Initiative central data platform requirements and timelines developed through the HEAL consortium. It is expected that all data collected by award recipients and their collaborators, as part of the NIH HEAL Initiative, will be shared with the NIH HEAL Initiative central data platform. Institutions who receive Data and/or Materials from this award for performance of activities under this award are required to use the Data and/or Materials only as outlined by the NIH HEAL Initiative, in a manner that is consistent with applicable state and federal laws and regulations, including any informed consent requirements and the terms of the institution's NIH funding, including NOT-OD-17-109 and 42 U.S.C. 241(d).
Publications
Hurlocker MC, Kirouac M, Gillezeau C, Hijaz D, Moniz-Lewis DIK, Carlon HA, Coleman GC, Ilgen MA, Pearson MR, Vowles KE, Witkiewitz K. Study Protocol for the Healing Opioid Misuse and Pain Through Engagement Trial: Integrated Treatment for Individuals With Co-occurring Chronic Pain and Opioid Use Disorder. Subst Use Addctn J. 2025 Jan;46(1):192-196. doi: 10.1177/29767342241228126. Epub 2024 Jan 31.
PubMed 38294429
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Treatment for Achieving Holistic Recovery From Comorbid Chronic Pain and Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05571917
- Acronym / sponsor ID
- HOPE / 2206006784
- Conditions
- Opioid Use Disorder, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- University of Michigan, Wake Forest University, National Institute on Drug Abuse (NIDA)
- Study start
- 5 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Oct 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 study is a multisite randomized clinical trial of a treatment designed to reduce pain interference while simultaneously addressing relapse prevention among individuals who have co-occurring chronic pain and Opioid Use Disorder (OUD). This study will recruit approximately 160 individuals who are currently being treated in clinics specializing in the physician management of OUD. To increase generalizability of study findings and increase internal validity of the physician management component of treatment, all participants will be stabilized on buprenorphine for OUD as part of their usual clinical care. Individuals will be randomized to either: (1) enhanced usual care or (2) the integrated ACT + MBRP treatment. The investigators hypothesize that: (1) the combination of ACT + MBRP in buprenorphine-prescribed patients with chronic pain will be more efficacious across primary and secondary outcome measures in comparison to Enhanced Usual Care and (2) examination of treatment mechanism data will indicate treatment-related changes that are consistent with the theoretical models of ACT+MBRP.
Detailed description
Opioid prescription in the treatment of chronic pain is frequent and carries a consequent risk of poor treatment outcome, as well as higher morbidity and mortality in a clinically significant number of patients, particularly those who meet criteria for OUD. Despite the alarming increases in opioid misuse and OUD nationally, there are few treatment options available that target both pain-related interference and OUD in an integrated fashion among patients with chronic pain. To date, there are no evidence-based treatment options that aim to minimize pain interference while simultaneously addressing OUD among individuals with medication prescribed for OUD.
The present trial builds upon a pilot study that tested the feasibility of integrating two empirically-supported psychosocial interventions, ACT to reduce pain interference and MBRP to reduce opioid misuse. Following successful integration of the interventions, outcome analyses found that the integrated ACT + MBRP intervention reduced both pain interference and opioid misuse at a 6-month follow-up in comparison to physician management alone.
This study is a multisite randomized clinical trial that will recruit approximately 160 individuals who are currently being treated in clinics specializing in the physician management of OUD. To increase generalizability of study findings and increase internal validity of the physician management component of treatment, all participants will be stabilized on buprenorphine for OUD as part of their usual clinical care. Individuals will be randomized to either: (1) enhanced usual care or (2) the integrated ACT + MBRP treatment.
The primary outcome, pain interference, will be assessed at the end of the active treatment phase and at 6- and 12-month follow-ups. Secondary outcomes will include pain intensity, depression, and pain-related fear, and an exploratory outcome of self-report of substance use with urine testing for confirmation. Treatment mechanism variables, including chronic pain acceptance, engagement in values-based action, and opioid craving will be assessed weekly during the active phase of treatment.
Our overall hypotheses are that: (1) the combination of ACT + MBRP in buprenorphine-prescribed patients with chronic pain will be more efficacious across primary and secondary outcome measures in comparison to EUC and (2) examination of treatment mechanism data will indicate treatment-related changes that are consistent with the theoretical models of ACT+MBRP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A research coordinator who is not involved in the intervention phases of the study will randomize individuals to study arm. A block randomization method stratified by site and gender will be used with a random block size based on group scheduling, where groups will start with a group size of three to ten participants. The coordinator will generate a randomization list prior to the implementation phase. To further maintain masking, a research assistant who is not involved in the intervention phases of the study will administer all assessment measures.
| Arm | Type | Receives |
|---|---|---|
| ACT + MBRP Intervention | Experimental | Behavioral: Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP)The ACT + MBRP group will follow a manualized clinical protocol. Treatment will include 12 weekly, virtual group-based sessions, each lasting 90 minutes. Group sizes will range from three to ten participants. All sessions will be audio recorded for fidelity. Over the course of the group meetings, participants identify areas of meaningful functioning that have been adversely impacted by pain, learn methods to enhance pain willingness in the service of these meaningful areas, and practice present-focused awareness skills. Group sessions include discussions of the impact of pain and distress avoidance, identifying alternatives to this avoidance and establishing plans for behavior change, demonstration and role-playing exercises, and homework assignments. Participants are provided with a treatment manual to help guide and inform practice outside of group sessions. |
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Enhance Usual Care (EUC)The Enhanced Usual Care (EUC) condition will supplement standard practices within the study sites related to chronic pain and OUD education. Participants randomized to the EUC condition will receive a brochure (in-person, via email, or via text message) with a list of chronic pain treatment resources, signs and management of opioid overdose including naloxone, and overdose prevention, and will encouraged to schedule an appointment with a clinical provider if they would like to discuss any current or past symptoms. In addition to receiving the brochure, EUC condition participants will meet with a therapist remotely for approximately 15 minutes for a descriptive overview of the brochure. In this session, the therapist will point out the resources in the brochure and read the helpful tips out loud to the participant. This session will be audio recorded for fidelity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stabilized on a dose of buprenorphine for a period of at least 1 month. Buprenorphine stabilization will be defined as a consistent dose for at least 30 consecutive days.
- Willing to comply with all study procedures and be available for the duration of the study.
- Aged 18 years or older.
- Enrolled as a patient in one of the participating clinics.
- Presence of chronic pain for > 6 months in duration.
Key exclusion criteria (3 listed)
- Current or past diagnosis of schizophrenia, delusional disorder, psychotic or dissociative disorders.
- Unable to read English.
- Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).
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 |
|---|---|---|
| Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP)This intervention is an integrated psychosocial treatment of two established treatments for chronic pain and Opioid Use Disorder (OUD). This intervention focuses on reducing pain interference and preventing relapse to opioid misuse. | Behavioural | ACT + MBRP Intervention |
| Enhance Usual Care (EUC)This intervention consists of psychoeducational materials about chronic pain treatment resources, signs and management of opioid overdose and overdose prevention. This intervention also consists of a brief, remote visit with a study therapist, lasting approximately 15 minutes. | Behavioural | Enhanced Usual Care (EUC) |
Primary outcome
Change in Pain Interference
Time frame: Change from baseline through 12-month follow-up period
Pain interference between participants randomized to ACT+MBRP vs EUC assessed by Pain interference will be measured via Patient Reported Outcome Measurement Information System (PROMIS) Bank v1.0 Pain Interference: The National Institutes of Health (NIH) PROMIS toolkit measure for pain interference. Each item ranges from 0 (not at all) to 5 (very much interfered) and higher scores reflect more severe pain interference. This questionnaire asks about pain interference in the past 7 days (collected once at baseline, post-treatment, and months 6 and 12).
6 secondary outcomes
Change in Pain Intensity
Time frame: Change from baseline through 12-month follow-up period
Change in Depression
Time frame: Change from baseline through 12-month follow-up period
Change in Pain-Related Anxiety
Time frame: Change from baseline through 12-month follow-up period
Change in Pain Acceptance
Time frame: Change from baseline through 12-week treatment period and 12-month follow-up period
Change in Valued-Action
Time frame: Change from baseline through 12-week treatment period and 12-month follow-up period
Change in Craving
Time frame: Change from baseline through 12-week treatment period and 12-month follow-up period
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 Oct 2026.
- Derived from this study: PubMed 38294429Hurlocker MC, Kirouac M, Gillezeau C, Hijaz D, Moniz-Lewis DIK, Carlon HA, Coleman GC, Ilgen MA, Pearson MR, Vowles KE, Witkiewitz K. Study Protocol for the Healing Opioid Misuse and Pain Through Engagement Trial: Integrated Treatment for Individuals With Co-occurring Chronic Pain and Opioid Use Disorder. Subst Use Addctn J. 2025 Jan;46(1):192-196. doi: 10.1177/29767342241228126. Epub 2024 Jan 31.
- Individual participant dataSharing planned: Yes. All applicable NIH Data Sharing Policies: See https://grants.nih.gov/policy/sharing.htm for policies and resources. The investigators will comply with all NIH HEAL Initiative Data Sharing policies established during the project period. This includes compliance with the NIH HEAL Initiative central data platform requirements and timelines developed through the HEAL consortium. It is expected that all data collected by award recipients and their collaborators, as part of the NIH HEAL Initiative, will be shared with the NIH HEAL Initiative central data platform. Institutions who receive Data and/or Materials from this award for performance of activities under this award are required to use the Data and/or Materials only as outlined by the NIH HEAL Initiative, in a manner that is consistent with applicable state and federal laws and regulations, including any informed consent requirements and the terms of the institution's NIH funding, including NOT-OD-17-109 and 42 U.S.C. 241(d).
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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.
Katie Witkiewitz, PhD principal investigator
University of New Mexico
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP) in people with Opioid Use Disorder and Chronic Pain, run by University of New Mexico at 2 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 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Change in Pain Interference (time frame: Change from baseline through 12-month follow-up period). 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 NCT05571917, 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 30 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.