Chronic Pain, Opioid Use
Conditions
Brief 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). 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.
Interventions
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.
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.
Sponsors
University of Utah
National Center for Complementary and Integrative Health (NCCIH)
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Two-arm randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English-speaking * Age ≥18 * Currently on methadone * Experiencing non-malignant pain for a duration of 3 months or longer.
Exclusion criteria
* Severe cognitive impairment or active psychosis * Suicide risk * Inability to attend the MORE group, if randomized to that arm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug Relapse Through 16-weeks. | 16-weeks | Drug use as measured by self-report through EMA, follow-back, or urine screen. |
| Methadone Treatment Drop Out Through 16-weeks. | 16-weeks | Methadone treatment drop out as measured by clinic report. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days of Other Drug Use. | 16-weeks | 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. |
| Changes in Craving | 16-weeks | Change in craving ecological momentary rating on scale from 0 (e.g., no craving) to 6 (intense craving) to 10 (very strong craving) . |
| Number of Days of Any Drug Use | 16-weeks | 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. |
| Changes in Depression. | 16-weeks | 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. |
| Changes in Anxiety. | 16-weeks | 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. |
| Changes in Pain. | 16-weeks | 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. |
| Number of Days of Opioid Use. | 16-weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 77 |
| 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. | 77 |
| Total | 154 |
Baseline characteristics
| Characteristic | Methadone Treatment (MT) as Usual | Total | Mindfulness Oriented Recovery Enhancement |
|---|---|---|---|
| Age, Continuous | 47.7 years STANDARD_DEVIATION 11.3 | 48.5 years STANDARD_DEVIATION 11.8 | 49.2 years STANDARD_DEVIATION 10.9 |
| Anxiety | 23.3 units on a scale STANDARD_DEVIATION 15.4 | 24.4 units on a scale STANDARD_DEVIATION 14.7 | 25.5 units on a scale STANDARD_DEVIATION 14.1 |
| Completed less than high school | 17 Participants | 36 Participants | 19 Participants |
| Depression | 22.6 units on a scale STANDARD_DEVIATION 11 | 22.6 units on a scale STANDARD_DEVIATION 11.2 | 22.5 units on a scale STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 22 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 132 Participants | 66 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Number of years on methadone | 3.1 years STANDARD_DEVIATION 4.3 | 3.6 years STANDARD_DEVIATION 4.6 | 4.2 years STANDARD_DEVIATION 4.7 |
| Pain | 5.2 units on a scale STANDARD_DEVIATION 2.5 | 5.2 units on a scale STANDARD_DEVIATION 2.6 | 5.1 units on a scale STANDARD_DEVIATION 2.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 62 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 12 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 42 Participants | 80 Participants | 38 Participants |
| Region of Enrollment United States | 77 participants | 154 participants | 77 participants |
| Sex: Female, Male Female | 44 Participants | 88 Participants | 44 Participants |
| Sex: Female, Male Male | 33 Participants | 66 Participants | 33 Participants |
| Unemployed | 66 Participants | 132 Participants | 66 Participants |
| Used opioids in the past 30 days | 40 Participants | 84 Participants | 44 Participants |
| Uses any drugs in the past 30 days | 50 Participants | 112 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 77 | 0 / 77 |
| other Total, other adverse events | 0 / 77 | 0 / 77 |
| serious Total, serious adverse events | 0 / 77 | 0 / 77 |
Outcome results
Primary
Drug Relapse Through 16-weeks.
Drug use as measured by self-report through EMA, follow-back, or urine screen.
Time frame: 16-weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness Oriented Recovery Enhancement | Drug Relapse Through 16-weeks. | 39 Participants |
| Methadone Treatment (MT) as Usual | Drug Relapse Through 16-weeks. | 44 Participants |
p-value: 0.0295% CI: [0.37, 0.9]proportional hazard regression
Primary
Methadone Treatment Drop Out Through 16-weeks.
Methadone treatment drop out as measured by clinic report.
Time frame: 16-weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness Oriented Recovery Enhancement | Methadone Treatment Drop Out Through 16-weeks. | 10 Participants |
| Methadone Treatment (MT) as Usual | Methadone Treatment Drop Out Through 16-weeks. | 17 Participants |
p-value: 0.0495% CI: [0.18, 0.96]proportional hazard regression
Secondary
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.
Time frame: 16-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Oriented Recovery Enhancement | Changes in Anxiety. | -2.51 units on a scale | Standard Error 2.47 |
| Methadone Treatment (MT) as Usual | Changes in Anxiety. | 1.31 units on a scale | Standard Error 1.42 |
Secondary
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) .
Time frame: 16-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Oriented Recovery Enhancement | Changes in Craving | -.49 units on a scale | Standard Error 0.3 |
| Methadone Treatment (MT) as Usual | Changes in Craving | -.35 units on a scale | Standard Error 0.15 |
Secondary
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.
Time frame: 16-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Oriented Recovery Enhancement | Changes in Depression. | -3.68 units on a scale | Standard Error 1.09 |
| Methadone Treatment (MT) as Usual | Changes in Depression. | -2.36 units on a scale | Standard Error 1.06 |
Secondary
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.
Time frame: 16-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Oriented Recovery Enhancement | Changes in Pain. | -.62 units on a scale | Standard Error 0.16 |
| Methadone Treatment (MT) as Usual | Changes in Pain. | -.25 units on a scale | Standard Error 0.13 |
Secondary
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.
Time frame: 16-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Oriented Recovery Enhancement | Number of Days of Any Drug Use | 13.9 days | Standard Deviation 16.9 |
| Methadone Treatment (MT) as Usual | Number of Days of Any Drug Use | 21.7 days | Standard Deviation 23.8 |
Secondary
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.
Time frame: 16-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Oriented Recovery Enhancement | Number of Days of Opioid Use. | 7.9 days | Standard Deviation 13.2 |
| Methadone Treatment (MT) as Usual | Number of Days of Opioid Use. | 8.5 days | Standard Deviation 14.8 |
Secondary
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.
Time frame: 16-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Oriented Recovery Enhancement | Number of Days of Other Drug Use. | 9.8 days | Standard Deviation 14.8 |
| Methadone Treatment (MT) as Usual | Number of Days of Other Drug Use. | 18.3 days | Standard Deviation 23 |