Trial Outcomes & Findings for Mindfulness Oriented Recovery Enhancement for Chronic Pain and Opioid Relapse (NCT NCT04491968)
NCT ID: NCT04491968
Last Updated: 2025-03-10
Results Overview
Drug use as measured by self-report through EMA, follow-back, or urine screen.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
154 participants
Primary outcome timeframe
16-weeks
Results posted on
2025-03-10
Participant Flow
Participant milestones
| Measure |
Mindfulness Oriented Recovery Enhancement
Participants in the MORE plus usual care group attended 8 weekly, 2-hour group sessions, remotely, through video conferencing. Participants were provided with a tablet and data plan to ensure access to the internet. MORE sessions involved mindfulness to strengthen self-regulation of drug use and reduce pain, reappraisal to regulate negative emotions and reduce craving by contemplating drug use consequences, and savoring to increase positive emotions and augment natural reward processing.Participants were taught to replace the reward obtained from drug use by self-generating natural reward via mindfulness and savoring. MORE also included techniques designed to mindfully honor the recovery process and promote reflection on the reasons for taking MOUD. Each session began with a mindful breathing meditation, followed by group processing of the meditation. Next, therapists debriefed participants' weekly homework practice of mindfulness, reappraisal, and savoring skills. These group processing efforts involved social-behavioral learning principles including positive reinforcement and shaping to maximize learning and motivation. Psychoeducational material and experiential exercises were then introduced, and participants were asked to practice 15 minutes of mindfulness/reappraisal/savoring skills daily.
|
Methadone Treatment (MT) as Usual
In MT programs, patients take methadone daily and come to the clinic regularly to get their dose. However, at the time of the study, most participants received doses at home due to the COVID-19 pandemic. MT clinic individual and group therapy (neither involving mindfulness) was usually delivered through telehealth due to the COVID-19 pandemic.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
77
|
|
Overall Study
COMPLETED
|
65
|
71
|
|
Overall Study
NOT COMPLETED
|
12
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindfulness Oriented Recovery Enhancement for Chronic Pain and Opioid Relapse
Baseline characteristics by cohort
| Measure |
Mindfulness Oriented Recovery Enhancement
n=77 Participants
Participants in the MORE plus usual care group attended 8 weekly, 2-hour group sessions, remotely, through video conferencing. Participants were provided with a tablet and data plan to ensure access to the internet. MORE sessions involved mindfulness to strengthen self-regulation of drug use and reduce pain, reappraisal to regulate negative emotions and reduce craving by contemplating drug use consequences, and savoring to increase positive emotions and augment natural reward processing.Participants were taught to replace the reward obtained from drug use by self-generating natural reward via mindfulness and savoring. MORE also included techniques designed to mindfully honor the recovery process and promote reflection on the reasons for taking MOUD. Each session began with a mindful breathing meditation, followed by group processing of the meditation. Next, therapists debriefed participants' weekly homework practice of mindfulness, reappraisal, and savoring skills. These group processing efforts involved social-behavioral learning principles including positive reinforcement and shaping to maximize learning and motivation. Psychoeducational material and experiential exercises were then introduced, and participants were asked to practice 15 minutes of mindfulness/reappraisal/savoring skills daily.
|
Methadone Treatment (MT) as Usual
n=77 Participants
In MT programs, patients take methadone daily and come to the clinic regularly to get their dose. However, at the time of the study, most participants received doses at home due to the COVID-19 pandemic. MT clinic individual and group therapy (neither involving mindfulness) was usually delivered through telehealth due to the COVID-19 pandemic.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.2 years
STANDARD_DEVIATION 10.9 • n=99 Participants
|
47.7 years
STANDARD_DEVIATION 11.3 • n=107 Participants
|
48.5 years
STANDARD_DEVIATION 11.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=99 Participants
|
77 participants
n=107 Participants
|
154 participants
n=206 Participants
|
|
Completed less than high school
|
19 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Unemployed
|
66 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
|
Used opioids in the past 30 days
|
44 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Uses any drugs in the past 30 days
|
62 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Number of years on methadone
|
4.2 years
STANDARD_DEVIATION 4.7 • n=99 Participants
|
3.1 years
STANDARD_DEVIATION 4.3 • n=107 Participants
|
3.6 years
STANDARD_DEVIATION 4.6 • n=206 Participants
|
|
Depression
|
22.5 units on a scale
STANDARD_DEVIATION 11.6 • n=99 Participants
|
22.6 units on a scale
STANDARD_DEVIATION 11.0 • n=107 Participants
|
22.6 units on a scale
STANDARD_DEVIATION 11.2 • n=206 Participants
|
|
Anxiety
|
25.5 units on a scale
STANDARD_DEVIATION 14.1 • n=99 Participants
|
23.3 units on a scale
STANDARD_DEVIATION 15.4 • n=107 Participants
|
24.4 units on a scale
STANDARD_DEVIATION 14.7 • n=206 Participants
|
|
Pain
|
5.1 units on a scale
STANDARD_DEVIATION 2.7 • n=99 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 2.5 • n=107 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 2.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: 16-weeksDrug use as measured by self-report through EMA, follow-back, or urine screen.
Outcome measures
| Measure |
Methadone Treatment (MT) as Usual
n=77 Participants
In MT programs, patients take methadone daily and come to the clinic regularly to get their dose. However, at the time of the study, most participants received doses at home due to the COVID-19 pandemic. MT clinic individual and group therapy (neither involving mindfulness) was usually delivered through telehealth due to the COVID-19 pandemic.
|
Mindfulness Oriented Recovery Enhancement
n=77 Participants
Participants in the MORE plus usual care group attended 8 weekly, 2-hour group sessions, remotely, through video conferencing. Participants were provided with a tablet and data plan to ensure access to the internet. MORE sessions involved mindfulness to strengthen self-regulation of drug use and reduce pain, reappraisal to regulate negative emotions and reduce craving by contemplating drug use consequences, and savoring to increase positive emotions and augment natural reward processing.Participants were taught to replace the reward obtained from drug use by self-generating natural reward via mindfulness and savoring. MORE also included techniques designed to mindfully honor the recovery process and promote reflection on the reasons for taking MOUD. Each session began with a mindful breathing meditation, followed by group processing of the meditation. Next, therapists debriefed participants' weekly homework practice of mindfulness, reappraisal, and savoring skills. These group processing efforts involved social-behavioral learning principles including positive reinforcement and shaping to maximize learning and motivation. Psychoeducational material and experiential exercises were then introduced, and participants were asked to practice 15 minutes of mindfulness/reappraisal/savoring skills daily.
|
|---|---|---|
|
Drug Relapse Through 16-weeks.
|
44 Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: 16-weeksMethadone treatment drop out as measured by clinic report.
Outcome measures
| Measure |
Methadone Treatment (MT) as Usual
n=77 Participants
In MT programs, patients take methadone daily and come to the clinic regularly to get their dose. However, at the time of the study, most participants received doses at home due to the COVID-19 pandemic. MT clinic individual and group therapy (neither involving mindfulness) was usually delivered through telehealth due to the COVID-19 pandemic.
|
Mindfulness Oriented Recovery Enhancement
n=77 Participants
Participants in the MORE plus usual care group attended 8 weekly, 2-hour group sessions, remotely, through video conferencing. Participants were provided with a tablet and data plan to ensure access to the internet. MORE sessions involved mindfulness to strengthen self-regulation of drug use and reduce pain, reappraisal to regulate negative emotions and reduce craving by contemplating drug use consequences, and savoring to increase positive emotions and augment natural reward processing.Participants were taught to replace the reward obtained from drug use by self-generating natural reward via mindfulness and savoring. MORE also included techniques designed to mindfully honor the recovery process and promote reflection on the reasons for taking MOUD. Each session began with a mindful breathing meditation, followed by group processing of the meditation. Next, therapists debriefed participants' weekly homework practice of mindfulness, reappraisal, and savoring skills. These group processing efforts involved social-behavioral learning principles including positive reinforcement and shaping to maximize learning and motivation. Psychoeducational material and experiential exercises were then introduced, and participants were asked to practice 15 minutes of mindfulness/reappraisal/savoring skills daily.
|
|---|---|---|
|
Methadone Treatment Drop Out Through 16-weeks.
|
17 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 16-weeksA 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.
Outcome measures
| Measure |
Methadone Treatment (MT) as Usual
n=77 Participants
In MT programs, patients take methadone daily and come to the clinic regularly to get their dose. However, at the time of the study, most participants received doses at home due to the COVID-19 pandemic. MT clinic individual and group therapy (neither involving mindfulness) was usually delivered through telehealth due to the COVID-19 pandemic.
|
Mindfulness Oriented Recovery Enhancement
n=77 Participants
Participants in the MORE plus usual care group attended 8 weekly, 2-hour group sessions, remotely, through video conferencing. Participants were provided with a tablet and data plan to ensure access to the internet. MORE sessions involved mindfulness to strengthen self-regulation of drug use and reduce pain, reappraisal to regulate negative emotions and reduce craving by contemplating drug use consequences, and savoring to increase positive emotions and augment natural reward processing.Participants were taught to replace the reward obtained from drug use by self-generating natural reward via mindfulness and savoring. MORE also included techniques designed to mindfully honor the recovery process and promote reflection on the reasons for taking MOUD. Each session began with a mindful breathing meditation, followed by group processing of the meditation. Next, therapists debriefed participants' weekly homework practice of mindfulness, reappraisal, and savoring skills. These group processing efforts involved social-behavioral learning principles including positive reinforcement and shaping to maximize learning and motivation. Psychoeducational material and experiential exercises were then introduced, and participants were asked to practice 15 minutes of mindfulness/reappraisal/savoring skills daily.
|
|---|---|---|
|
Number of Days of Any Drug Use
|
21.7 days
Standard Deviation 23.8
|
13.9 days
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: 16-weeksNumber 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.
Outcome measures
| Measure |
Methadone Treatment (MT) as Usual
n=77 Participants
In MT programs, patients take methadone daily and come to the clinic regularly to get their dose. However, at the time of the study, most participants received doses at home due to the COVID-19 pandemic. MT clinic individual and group therapy (neither involving mindfulness) was usually delivered through telehealth due to the COVID-19 pandemic.
|
Mindfulness Oriented Recovery Enhancement
n=77 Participants
Participants in the MORE plus usual care group attended 8 weekly, 2-hour group sessions, remotely, through video conferencing. Participants were provided with a tablet and data plan to ensure access to the internet. MORE sessions involved mindfulness to strengthen self-regulation of drug use and reduce pain, reappraisal to regulate negative emotions and reduce craving by contemplating drug use consequences, and savoring to increase positive emotions and augment natural reward processing.Participants were taught to replace the reward obtained from drug use by self-generating natural reward via mindfulness and savoring. MORE also included techniques designed to mindfully honor the recovery process and promote reflection on the reasons for taking MOUD. Each session began with a mindful breathing meditation, followed by group processing of the meditation. Next, therapists debriefed participants' weekly homework practice of mindfulness, reappraisal, and savoring skills. These group processing efforts involved social-behavioral learning principles including positive reinforcement and shaping to maximize learning and motivation. Psychoeducational material and experiential exercises were then introduced, and participants were asked to practice 15 minutes of mindfulness/reappraisal/savoring skills daily.
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|---|---|---|
|
Number of Days of Opioid Use.
|
8.5 days
Standard Deviation 14.8
|
7.9 days
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: 16-weeksNumber 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.
Outcome measures
| Measure |
Methadone Treatment (MT) as Usual
n=77 Participants
In MT programs, patients take methadone daily and come to the clinic regularly to get their dose. However, at the time of the study, most participants received doses at home due to the COVID-19 pandemic. MT clinic individual and group therapy (neither involving mindfulness) was usually delivered through telehealth due to the COVID-19 pandemic.
|
Mindfulness Oriented Recovery Enhancement
n=77 Participants
Participants in the MORE plus usual care group attended 8 weekly, 2-hour group sessions, remotely, through video conferencing. Participants were provided with a tablet and data plan to ensure access to the internet. MORE sessions involved mindfulness to strengthen self-regulation of drug use and reduce pain, reappraisal to regulate negative emotions and reduce craving by contemplating drug use consequences, and savoring to increase positive emotions and augment natural reward processing.Participants were taught to replace the reward obtained from drug use by self-generating natural reward via mindfulness and savoring. MORE also included techniques designed to mindfully honor the recovery process and promote reflection on the reasons for taking MOUD. Each session began with a mindful breathing meditation, followed by group processing of the meditation. Next, therapists debriefed participants' weekly homework practice of mindfulness, reappraisal, and savoring skills. These group processing efforts involved social-behavioral learning principles including positive reinforcement and shaping to maximize learning and motivation. Psychoeducational material and experiential exercises were then introduced, and participants were asked to practice 15 minutes of mindfulness/reappraisal/savoring skills daily.
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|---|---|---|
|
Number of Days of Other Drug Use.
|
18.3 days
Standard Deviation 23.0
|
9.8 days
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: 16-weeksChange in craving ecological momentary rating on scale from 0 (e.g., no craving) to 6 (intense craving) to 10 (very strong craving) .
Outcome measures
| Measure |
Methadone Treatment (MT) as Usual
n=72 Participants
In MT programs, patients take methadone daily and come to the clinic regularly to get their dose. However, at the time of the study, most participants received doses at home due to the COVID-19 pandemic. MT clinic individual and group therapy (neither involving mindfulness) was usually delivered through telehealth due to the COVID-19 pandemic.
|
Mindfulness Oriented Recovery Enhancement
n=73 Participants
Participants in the MORE plus usual care group attended 8 weekly, 2-hour group sessions, remotely, through video conferencing. Participants were provided with a tablet and data plan to ensure access to the internet. MORE sessions involved mindfulness to strengthen self-regulation of drug use and reduce pain, reappraisal to regulate negative emotions and reduce craving by contemplating drug use consequences, and savoring to increase positive emotions and augment natural reward processing.Participants were taught to replace the reward obtained from drug use by self-generating natural reward via mindfulness and savoring. MORE also included techniques designed to mindfully honor the recovery process and promote reflection on the reasons for taking MOUD. Each session began with a mindful breathing meditation, followed by group processing of the meditation. Next, therapists debriefed participants' weekly homework practice of mindfulness, reappraisal, and savoring skills. These group processing efforts involved social-behavioral learning principles including positive reinforcement and shaping to maximize learning and motivation. Psychoeducational material and experiential exercises were then introduced, and participants were asked to practice 15 minutes of mindfulness/reappraisal/savoring skills daily.
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|---|---|---|
|
Changes in Craving
|
-.35 units on a scale
Standard Error .15
|
-.49 units on a scale
Standard Error .30
|
SECONDARY outcome
Timeframe: 16-weeksParticipants 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.
Outcome measures
| Measure |
Methadone Treatment (MT) as Usual
n=72 Participants
In MT programs, patients take methadone daily and come to the clinic regularly to get their dose. However, at the time of the study, most participants received doses at home due to the COVID-19 pandemic. MT clinic individual and group therapy (neither involving mindfulness) was usually delivered through telehealth due to the COVID-19 pandemic.
|
Mindfulness Oriented Recovery Enhancement
n=73 Participants
Participants in the MORE plus usual care group attended 8 weekly, 2-hour group sessions, remotely, through video conferencing. Participants were provided with a tablet and data plan to ensure access to the internet. MORE sessions involved mindfulness to strengthen self-regulation of drug use and reduce pain, reappraisal to regulate negative emotions and reduce craving by contemplating drug use consequences, and savoring to increase positive emotions and augment natural reward processing.Participants were taught to replace the reward obtained from drug use by self-generating natural reward via mindfulness and savoring. MORE also included techniques designed to mindfully honor the recovery process and promote reflection on the reasons for taking MOUD. Each session began with a mindful breathing meditation, followed by group processing of the meditation. Next, therapists debriefed participants' weekly homework practice of mindfulness, reappraisal, and savoring skills. These group processing efforts involved social-behavioral learning principles including positive reinforcement and shaping to maximize learning and motivation. Psychoeducational material and experiential exercises were then introduced, and participants were asked to practice 15 minutes of mindfulness/reappraisal/savoring skills daily.
|
|---|---|---|
|
Changes in Pain.
|
-.25 units on a scale
Standard Error .13
|
-.62 units on a scale
Standard Error .16
|
SECONDARY outcome
Timeframe: 16-weeksDepression 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.
Outcome measures
| Measure |
Methadone Treatment (MT) as Usual
n=77 Participants
In MT programs, patients take methadone daily and come to the clinic regularly to get their dose. However, at the time of the study, most participants received doses at home due to the COVID-19 pandemic. MT clinic individual and group therapy (neither involving mindfulness) was usually delivered through telehealth due to the COVID-19 pandemic.
|
Mindfulness Oriented Recovery Enhancement
n=77 Participants
Participants in the MORE plus usual care group attended 8 weekly, 2-hour group sessions, remotely, through video conferencing. Participants were provided with a tablet and data plan to ensure access to the internet. MORE sessions involved mindfulness to strengthen self-regulation of drug use and reduce pain, reappraisal to regulate negative emotions and reduce craving by contemplating drug use consequences, and savoring to increase positive emotions and augment natural reward processing.Participants were taught to replace the reward obtained from drug use by self-generating natural reward via mindfulness and savoring. MORE also included techniques designed to mindfully honor the recovery process and promote reflection on the reasons for taking MOUD. Each session began with a mindful breathing meditation, followed by group processing of the meditation. Next, therapists debriefed participants' weekly homework practice of mindfulness, reappraisal, and savoring skills. These group processing efforts involved social-behavioral learning principles including positive reinforcement and shaping to maximize learning and motivation. Psychoeducational material and experiential exercises were then introduced, and participants were asked to practice 15 minutes of mindfulness/reappraisal/savoring skills daily.
|
|---|---|---|
|
Changes in Depression.
|
-2.36 units on a scale
Standard Error 1.06
|
-3.68 units on a scale
Standard Error 1.09
|
SECONDARY outcome
Timeframe: 16-weeksAnxiety 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.
Outcome measures
| Measure |
Methadone Treatment (MT) as Usual
n=77 Participants
In MT programs, patients take methadone daily and come to the clinic regularly to get their dose. However, at the time of the study, most participants received doses at home due to the COVID-19 pandemic. MT clinic individual and group therapy (neither involving mindfulness) was usually delivered through telehealth due to the COVID-19 pandemic.
|
Mindfulness Oriented Recovery Enhancement
n=77 Participants
Participants in the MORE plus usual care group attended 8 weekly, 2-hour group sessions, remotely, through video conferencing. Participants were provided with a tablet and data plan to ensure access to the internet. MORE sessions involved mindfulness to strengthen self-regulation of drug use and reduce pain, reappraisal to regulate negative emotions and reduce craving by contemplating drug use consequences, and savoring to increase positive emotions and augment natural reward processing.Participants were taught to replace the reward obtained from drug use by self-generating natural reward via mindfulness and savoring. MORE also included techniques designed to mindfully honor the recovery process and promote reflection on the reasons for taking MOUD. Each session began with a mindful breathing meditation, followed by group processing of the meditation. Next, therapists debriefed participants' weekly homework practice of mindfulness, reappraisal, and savoring skills. These group processing efforts involved social-behavioral learning principles including positive reinforcement and shaping to maximize learning and motivation. Psychoeducational material and experiential exercises were then introduced, and participants were asked to practice 15 minutes of mindfulness/reappraisal/savoring skills daily.
|
|---|---|---|
|
Changes in Anxiety.
|
1.31 units on a scale
Standard Error 1.42
|
-2.51 units on a scale
Standard Error 2.47
|
Adverse Events
Mindfulness Oriented Recovery Enhancement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Methadone Treatment (MT) as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nina Cooperman, Associate Professor
Rutgers Robert Wood Johnson Medical School
Phone: 7322358569
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place