Opioid UseNCT04491968
Mindfulness Oriented Recovery Enhancement for Chronic Pain and Opioid Relapse
A study testing Mindfulness Oriented Recovery Enhancement and Methadone Treatment as Usual in people with Opioid Use and Chronic Pain, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The objective of this study is to rigorously examine the impact of online MORE, delivered through video conference, on opioid use and chronic pain among individuals receiving methadone maintenance treatment (MMT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Chronic Pain
- What is being tested?
- Mindfulness Oriented Recovery Enhancement and Methadone Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2020to 8 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- Age ≥18
- Currently on methadone
- Experiencing non-malignant pain for a duration of 3 months or longer.
Who cannot join
- Severe cognitive impairment or active psychosis
- Suicide risk
- Inability to attend the MORE group, if randomized to that arm.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
About this study
Official title: Mindfulness Oriented Recovery Enhancement for Chronic Pain and Opioid Relapse as an Adjunct to Methadone Treatment
The objective of this study is to rigorously examine the impact of online MORE, delivered through video conference, on opioid use and chronic pain among individuals receiving methadone maintenance treatment (MMT). This study is a randomized controlled trial to test the efficacy of online MORE on opioid use and chronic pain immediately after treatment and 8-weeks post-treatment as compared to treatment as usual (TAU) among 154 individuals in MMT. Further, mediators (i.e., metacognitive awareness, negative emotion regulation, and natural reward processing) and moderators (i.e., gender, race, income, mental health, trauma, and MMT phase) of treatment response will be explored.
Read the detailed description
This study is a 2-arm individually randomized controlled trial design in which outcomes of MMT patients randomized to MORE are compared to outcomes of those randomized to treatment as usual (TAU). In this study (N=154), the investigators will randomize MMT patients with chronic pain to MORE (n=77) or TAU (n=77). The purpose of this study is to determine MORE's efficacy for increasing opioid abstinence relative to TAU. Individuals with pain who are receiving MMT for an opioid use disorder (OUD) will be recruited from two methadone clinics in New Jersey.
Participants will be recruited through flyers posted in the clinics, being approached by research assistants in the waiting room of their usual methadone clinic, and referral by clinic staff. The number of individuals who contact the study staff through the flyers or referral and who are approached by study staff in the clinics will be tracked. Number of individuals who refuse study participation and who consent to the study will also be tracked. If an individual is interested in study participation, a trained research assistant will lead the individual through the informed consent process in a private space.
Since MORE is a closed group, the cohorts of 14 participants at each site will be randomized to TAU or MORE. Once 14 participants at a particular clinic are enrolled and randomized the MORE group will begin.
Participants randomized to the MORE condition will participate in eight, weekly, two-hour group sessions, co-led by a clinic and study counselor. Each session will contain 7 participants and take place remotely, by video conference. Attendance at each session and reasons for missing sessions will be recorded. Participants randomized to the control condition will continue receiving treatment as usual.
All study participants will partake in a total of three interviews lasting up to 90 minutes and occurring, remotely, at baseline, 8- and 16- weeks post-baseline by telephone or video conference. Each participant will also complete a urine or saliva drug screen at each assessment. All attempts to reach participants to schedule follow-up assessments will be tracked. Participants will also complete cognitive testing (for approx. 30-45 minutes) at baseline and 8-weeks and ecological momentary assessments (EMA) conducted via smartphones or tablets, which will be provided to each participant by study staff. EMA participation will require the participant to respond to twice-daily prompts in which they will be asked a series of brief questions regarding their current mood and exposure to opioid triggers. Additionally, subjects will be asked to initiate responses when they experience serious craving or relapse to opioid use. Each EMA assessment will last approximately 3-5 minutes.
- Conditions
- Opioid Use, Chronic Pain
- Being tested
- Mindfulness Oriented Recovery Enhancement, Methadone Treatment as Usual
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Oriented Recovery EnhancementBehavioural
Also called MORE
MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
Methadone Treatment as UsualOther
Also called MMT, Treatment as Usual, TAU
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Oriented Recovery Enhancement | Experimental | The Mindfulness Oriented Recovery Enhancement arm will participate in eight, weekly, two-hour group sessions.MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day. Receives: Behavioral: Mindfulness Oriented Recovery Enhancement |
| Methadone Treatment as Usual | Other | In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups. Receives: Other: Methadone Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Relapse Through 16-weeks.
Drug use as measured by self-report through EMA, follow-back, or urine screen.
Measured: 16-weeks
Methadone Treatment Drop Out Through 16-weeks.
Methadone treatment drop out as measured by clinic report.
Measured: 16-weeks
Secondary outcomes (7)
Number of Days of Any Drug Use
A variable for number of days of drug use over 16 weeks were computed by counting the greatest number of days of drug use recorded through ecological momentary assessment, the Addiction Severity Index, or drug screen.
Measured: 16-weeks
Number of Days of Opioid Use.
Number of days of opioid use, other drug use, and any drug use over 16 weeks were computed by counting the greatest number of days of drug use recorded through ecological momentary assessment, Addiction Severity, Index, or drug screen.
Measured: 16-weeks
Number of Days of Other Drug Use.
Number of days of other drug use as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.
Measured: 16-weeks
Changes in Craving
Change in craving ecological momentary rating on scale from 0 (e.g., no craving) to 6 (intense craving) to 10 (very strong craving) .
Measured: 16-weeks
Changes in Pain.
Participants were asked "How intense is your pain right now?" on a scale from 0 (no pain) to 10 (very intense pain) during 2 daily prompts over 16 weeks through ecological momentary assessment. Twice daily reports were averaged per week. Reduction in weekly pain average from baseline to 16 weeks was calculated and compared between groups.
Measured: 16-weeks
Changes in Depression.
Depression was measured with Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D scale is a widely used valid and reliable measure that consists of 20 items with potential scores ranging from 0 to 60. A score above 16 on the CES-D indicates clinically significant symptoms of depression. Higher scores on the CES-D indicates greater depression.
Measured: 16-weeks
Changes in Anxiety.
Anxiety was measured with the Beck Anxiety Inventory (BAI). The BAI is also a widely used, reliable, and valid scale that consists of 21 items with potential scores ranging from 0 to 63. A score of 16 or higher indicates clinically significant symptoms of anxiety. A higher score on the BAI indicates greater anxiety.
Measured: 16-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start13 Aug 2020
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Nina A. Cooperman, Psy. D., Rutgers, The State University of New Jersey
- Investigators
- Nina Cooperman, PsyD, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491968
- Sponsor's protocol ID
- Pro2019001687
- Other IDs
- R33AT010109
- Status last verified
- Feb 2025
- First submitted
- 9 Jul 2020
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Analyses of data generated from this project will be shared with the scientific community through publications in peer-reviewed journals and presentations at scientific meetings. The proposed research will include data from approximately 154 individuals in methadone maintenance treatment. The final dataset will include self-reported demographic and behavioral data from interviews with the subjects and laboratory data from urine or saliva specimens provided. Because we will be following study participants, we will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing.
Publications
Cooperman NA, Lu SE, Hanley AW, Puvananayagam T, Dooley-Budsock P, Kline A, Garland EL. Telehealth Mindfulness-Oriented Recovery Enhancement vs Usual Care in Individuals With Opioid Use Disorder and Pain: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Apr 1;81(4):338-346. doi: 10.1001/jamapsychiatry.2023.5138.
PubMed 38061786
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Oriented Recovery Enhancement for Chronic Pain and Opioid Relapse as an Adjunct to Methadone Treatment
- ClinicalTrials.gov ID
- NCT04491968
- Acronym / sponsor ID
- Pro2019001687
- Conditions
- Opioid Use, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- University of Utah, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Posted 10 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to rigorously examine the impact of online MORE, delivered through video conference, on opioid use and chronic pain among individuals receiving methadone maintenance treatment (MMT). This study is a randomized controlled trial to test the efficacy of online MORE on opioid use and chronic pain immediately after treatment and 8-weeks post-treatment as compared to treatment as usual (TAU) among 154 individuals in MMT. Further, mediators (i.e., metacognitive awareness, negative emotion regulation, and natural reward processing) and moderators (i.e., gender, race, income, mental health, trauma, and MMT phase) of treatment response will be explored.
Detailed description
This study is a 2-arm individually randomized controlled trial design in which outcomes of MMT patients randomized to MORE are compared to outcomes of those randomized to treatment as usual (TAU). In this study (N=154), the investigators will randomize MMT patients with chronic pain to MORE (n=77) or TAU (n=77). The purpose of this study is to determine MORE's efficacy for increasing opioid abstinence relative to TAU. Individuals with pain who are receiving MMT for an opioid use disorder (OUD) will be recruited from two methadone clinics in New Jersey.
Participants will be recruited through flyers posted in the clinics, being approached by research assistants in the waiting room of their usual methadone clinic, and referral by clinic staff. The number of individuals who contact the study staff through the flyers or referral and who are approached by study staff in the clinics will be tracked. Number of individuals who refuse study participation and who consent to the study will also be tracked. If an individual is interested in study participation, a trained research assistant will lead the individual through the informed consent process in a private space.
Since MORE is a closed group, the cohorts of 14 participants at each site will be randomized to TAU or MORE. Once 14 participants at a particular clinic are enrolled and randomized the MORE group will begin.
Participants randomized to the MORE condition will participate in eight, weekly, two-hour group sessions, co-led by a clinic and study counselor. Each session will contain 7 participants and take place remotely, by video conference. Attendance at each session and reasons for missing sessions will be recorded. Participants randomized to the control condition will continue receiving treatment as usual.
All study participants will partake in a total of three interviews lasting up to 90 minutes and occurring, remotely, at baseline, 8- and 16- weeks post-baseline by telephone or video conference. Each participant will also complete a urine or saliva drug screen at each assessment. All attempts to reach participants to schedule follow-up assessments will be tracked. Participants will also complete cognitive testing (for approx. 30-45 minutes) at baseline and 8-weeks and ecological momentary assessments (EMA) conducted via smartphones or tablets, which will be provided to each participant by study staff. EMA participation will require the participant to respond to twice-daily prompts in which they will be asked a series of brief questions regarding their current mood and exposure to opioid triggers. Additionally, subjects will be asked to initiate responses when they experience serious craving or relapse to opioid use. Each EMA assessment will last approximately 3-5 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Oriented Recovery Enhancement | Experimental | Behavioral: Mindfulness Oriented Recovery EnhancementThe Mindfulness Oriented Recovery Enhancement arm will participate in eight, weekly, two-hour group sessions.MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day. |
| Methadone Treatment as Usual | Other | Other: Methadone Treatment as UsualIn the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups. |
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
- Experiencing non-malignant pain for a duration of 3 months or longer.
Key exclusion criteria (3 listed)
- Severe cognitive impairment or active psychosis
- Suicide risk
- Inability to attend the MORE group, if randomized to that arm.
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 |
|---|---|---|
| Mindfulness Oriented Recovery EnhancementAlso: MOREMORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day. | Behavioural | Mindfulness Oriented Recovery Enhancement |
| Methadone Treatment as UsualAlso: MMT, Treatment as Usual, TAUIn the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups. | Other | Methadone Treatment as Usual |
Primary outcome
Drug Relapse Through 16-weeks.
Time frame: 16-weeks
Drug use as measured by self-report through EMA, follow-back, or urine screen.
Methadone Treatment Drop Out Through 16-weeks.
Time frame: 16-weeks
Methadone treatment drop out as measured by clinic report.
7 secondary outcomes
Number of Days of Any Drug Use
Time frame: 16-weeks
Number of Days of Opioid Use.
Time frame: 16-weeks
Number of Days of Other Drug Use.
Time frame: 16-weeks
Changes in Craving
Time frame: 16-weeks
Changes in Pain.
Time frame: 16-weeks
Changes in Depression.
Time frame: 16-weeks
Changes in Anxiety.
Time frame: 16-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38061786Cooperman NA, Lu SE, Hanley AW, Puvananayagam T, Dooley-Budsock P, Kline A, Garland EL. Telehealth Mindfulness-Oriented Recovery Enhancement vs Usual Care in Individuals With Opioid Use Disorder and Pain: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Apr 1;81(4):338-346. doi: 10.1001/jamapsychiatry.2023.5138.
- Individual participant dataSharing planned: Yes. Analyses of data generated from this project will be shared with the scientific community through publications in peer-reviewed journals and presentations at scientific meetings. The proposed research will include data from approximately 154 individuals in methadone maintenance treatment. The final dataset will include self-reported demographic and behavioral data from interviews with the subjects and laboratory data from urine or saliva specimens provided. Because we will be following study participants, we will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing.
Related trials for Opioid Use
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
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.
Nina Cooperman, PsyD principal investigator
Rutgers Robert Wood Johnson Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Oriented Recovery Enhancement and Methadone Treatment as Usual in people with Opioid Use and Chronic Pain, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 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: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Relapse Through 16-weeks. (time frame: 16-weeks). The study lists 2 primary outcomes in all. 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 NCT04491968, 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 10 Mar 2025.