Opioid UsePhase 3IMPOWR-MORENCT06032559
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment
A Phase 3 study testing MORE, SMP and TAU in people with Opioid Use and Pain, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
This hybrid implementation-effectiveness trial will evaluate Mindfulness-Oriented Recovery Enhancement (MORE) for patients with opioid use disorder receiving methadone treatment (MT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Pain
- What is being tested?
- MORE, SMP and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Sep 2023to 31 Jul 2027
- 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
- English-speaking
- age ≥18
- currently on methadone
- persistent or recurring pain that has lasted for a duration of 3 months of longer.
Who cannot join
- severe cognitive impairment (score >23 on Mini Mental Status Exam) or psychosis (positive SCID Psychotic Screen)
- suicidal risk (score ≥7 on Suicidal Behaviors Questionnaire)
- inability to attend or fully participate in intervention sessions or assessments
- previous formal mindfulness training (e.g., MBSR, MBRP) or MORE (from the R21 or R33 studies).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Nina Cooperman, 7322358569, cooperna@rwjms.rutgers.edu
- Recruiting
University of Utah
Salt Lake City, Utah, 04108
Ericc Garland, PhD, (801) 581-3826, Eric.Garland@socwk.utah.edu
About this study
Official title: Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use Disorder and Chronic Pain
This hybrid implementation-effectiveness trial will evaluate Mindfulness-Oriented Recovery Enhancement (MORE) for patients with opioid use disorder receiving methadone treatment (MT). The investigators will also assess barriers and facilitators to integrating MORE into methadone treatment, and evaluate the impact of a sustainable train-the-trainer model on provider burden, intervention fidelity, intervention engagement, and outcomes. Participants will be assigned to a higher intensity MORE implementation strategy, a minimal intensity implementation strategy consisting of a simple, scripted mindfulness practice (SMP) extracted from the MORE treatment manual with minimal training and feedback and no supervision, or methadone treatment as usual (TAU). We aim to:
- Examine barriers and facilitators to the implementation of MORE and SMP in MT and evaluate strategies for optimizing training, fidelity, and engagement.
- Evaluate the effectiveness and treatment fidelity of a higher intensity MORE implementation strategy versus a lower intensity, scripted mindfulness practice (SMP) implementation strategy as an adjunct to methadone TAU or methadone TAU, only. Outcomes include opioid and other drug use, craving, MT discontinuation, depression, anxiety, and physical pain (secondary outcomes) than patients randomized to TAU.
- Conditions
- Opioid Use, Pain
- Being tested
- MORE, SMP, TAU
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOREBehavioural
MORE plus TAU
SMPBehavioural
SMP plus TAU
TAUOther
TAU only
| Study group | Role | What they receive |
|---|---|---|
| MORE | Experimental | Eight group sessions of Mindfulness-Oriented Recovery Enhancement plus methadone treatment as usual (TAU) Receives: Behavioral: MORE |
| Scripted Mindfulness Practice (SMP) | Active comparator | Eight group sessions of scripted mindfulness practice plus TAU. Receives: Behavioral: SMP |
| Treatment-as-Usual | Active comparator | Methadone treatment as usual. Receives: Other: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of drug use
mber of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen.
Measured: Baseline through 52 weeks
Secondary outcomes (1)
Chronic Pain
Chronic pain measured by the Brief Pain Inventory Short Form (range 0-10, with higher scores indicating worse pain).
Measured: Baseline through 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start4 Sep 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 Jul 2027 (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 UseStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Utah
- Responsible party
- Principal investigator, Nina A. Cooperman, Psy. D., Rutgers, The State University of New Jersey
- Investigators
- Eric Garland, Ph, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032559
- Sponsor's protocol ID
- Pro2022001626
- Other IDs
- R01DA056537
- Acronym
- IMPOWR-MORE
- Status last verified
- Jul 2025
- First submitted
- 4 Sep 2023
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All participant data collected during the trial will be shared after de-identification.
Publications
Cooperman NA, Shen J, Gordon AJ, Garland EL. Commentary With Study Protocol: Implementation and Effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) as an Adjunct to Methadone Treatment for Opioid Use Disorder (IMPOWR-MORE). Subst Use Addctn J. 2025 Jan;46(1):160-165. doi: 10.1177/29767342241261890. Epub 2024 Jun 22.
PubMed 38907675
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use Disorder and Chronic Pain
- ClinicalTrials.gov ID
- NCT06032559
- Acronym / sponsor ID
- IMPOWR-MORE / Pro2022001626
- Conditions
- Opioid Use, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Utah
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 13 Sep 2023 (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 hybrid implementation-effectiveness trial will evaluate Mindfulness-Oriented Recovery Enhancement (MORE) for patients with opioid use disorder receiving methadone treatment (MT). The investigators will also assess barriers and facilitators to integrating MORE into methadone treatment, and evaluate the impact of a sustainable train-the-trainer model on provider burden, intervention fidelity, intervention engagement, and outcomes. Participants will be assigned to a higher intensity MORE implementation strategy, a minimal intensity implementation strategy consisting of a simple, scripted mindfulness practice (SMP) extracted from the MORE treatment manual with minimal training and feedback and no supervision, or methadone treatment as usual (TAU). We aim to:
- Examine barriers and facilitators to the implementation of MORE and SMP in MT and evaluate strategies for optimizing training, fidelity, and engagement.
- Evaluate the effectiveness and treatment fidelity of a higher intensity MORE implementation strategy versus a lower intensity, scripted mindfulness practice (SMP) implementation strategy as an adjunct to methadone TAU or methadone TAU, only. Outcomes include opioid and other drug use, craving, MT discontinuation, depression, anxiety, and physical pain (secondary outcomes) than patients randomized to TAU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MORE | Experimental | Behavioral: MOREEight group sessions of Mindfulness-Oriented Recovery Enhancement plus methadone treatment as usual (TAU) |
| Scripted Mindfulness Practice (SMP) | Active comparator | Behavioral: SMPEight group sessions of scripted mindfulness practice plus TAU. |
| Treatment-as-Usual | Active comparator | Other: TAUMethadone 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 (4 listed)
- English-speaking
- age ≥18
- currently on methadone
- persistent or recurring pain that has lasted for a duration of 3 months of longer.
Key exclusion criteria (4 listed)
- severe cognitive impairment (score >23 on Mini Mental Status Exam) or psychosis (positive SCID Psychotic Screen)
- suicidal risk (score ≥7 on Suicidal Behaviors Questionnaire)
- inability to attend or fully participate in intervention sessions or assessments
- previous formal mindfulness training (e.g., MBSR, MBRP) or MORE (from the R21 or R33 studies).
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 |
|---|---|---|
| MOREMORE plus TAU | Behavioural | MORE |
| SMPSMP plus TAU | Behavioural | Scripted Mindfulness Practice (SMP) |
| TAUTAU only | Other | Treatment-as-Usual |
Primary outcome
Days of drug use
Time frame: Baseline through 52 weeks
mber of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen.
1 secondary outcome
Chronic Pain
Time frame: Baseline through 52 weeks
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 Jul 2025.
- Derived from this study: PubMed 38907675Cooperman NA, Shen J, Gordon AJ, Garland EL. Commentary With Study Protocol: Implementation and Effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) as an Adjunct to Methadone Treatment for Opioid Use Disorder (IMPOWR-MORE). Subst Use Addctn J. 2025 Jan;46(1):160-165. doi: 10.1177/29767342241261890. Epub 2024 Jun 22.
- Individual participant dataSharing planned: Yes. All participant data collected during the trial will be shared after de-identification.
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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.
Eric Garland, Ph principal investigator
Rutgers Robert Wood Johnson Medical School
2 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 MORE, SMP and TAU in people with Opioid Use and Pain, run by Rutgers, The State University of New Jersey 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 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: looking for participants now, as of the sponsor's last update on 30 Jul 2025. 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.
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 Nina Cooperman, PsyD (732-235-8569, cooperna@rwjms.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of drug use (time frame: Baseline through 52 weeks). 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 NCT06032559, 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 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.