Chronic Pain, Opioid Use
Conditions
Keywords
opioid, chronic pain, methadone, mindfulness
Brief summary
This pilot study aims to evaluate the impact of a novel intervention, Mindfulness Oriented Recovery Enhancement (MORE), on opioid use and chronic pain among individuals receiving methadone maintenance treatment (MMT). The main goal of this pilot study is to test the feasibility of our study methods before conducting a clinical trial to assess MORE with respect to a range of clinical outcomes. This study will involve a 2-arm individually randomized controlled trial design that compares MORE and treatment as usual (TAU).
Detailed description
This pilot 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 the pilot study (R21; N=30), we will randomize MMT patients with chronic pain to MORE (n=15) or TAU (n=15). This study phase will focus on establishing study feasibility in recruiting, retaining, and following up study participants before progressing to a larger Phase II clinical trial (R33, N=150). Participants 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, we will randomize cohorts of 14-16 participants (depending on speed of recruitment) at each site to TAU or MORE with block randomization. Once we 14-16 participants at a particular clinic, we will randomize participants to MORE or TAU, and the MORE group will begin. Participants randomized to the MORE condition will participate in eight, weekly, two-hour group sessions led by a clinic or study counselor. Each session will contain 6-8 participants and take place in a private room at the methadone clinic. 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 at baseline, 8- and 16- weeks post-baseline in private rooms in the methadone clinics. Each participant will also have a urine or saliva sample collected during 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, 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.
BEHAVIORALMethadone program behavioral treatment as usual
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
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two-arm randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * English-speaking * Been in methadone treatment for at least 3 months * Experience a non-malignant pain (with an intensity level of 8 or higher on the Gracely Box Scale) for a duration of 2 months or longer.
Exclusion criteria
* Exhibit cognitive impairment (score \<24 on the Mini Mental Status Exam) * Exhibit psychosis (positive SCID Psychotic Screen), * Are at suicidal risk (positive score on ASQ Suicide Risk Screening Tool) * Unable to attend group sessions due to distance, work, commitments or other logistical problems, * Are currently pregnant or breastfeeding * Are planning to be pregnant or breastfeeding the next 16 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Sessions Completed | At 8-weeks (post treatment period completion). | The mean percentage of sessions completed by study participants randomized to MORE. |
| Percentage Baselines Completed | At baseline, | Percentage of people who completed baseline assessments. |
| 8-weeks Completed | At 8-weeks. | The number of participants who complete 8-week assessments. |
| Study Refusal | Baseline | The number of individuals who who refuse participation when offered. |
| Individuals Screened | Baseline (study enrollment) | The number of individuals screened and eligible/ineligible. |
| Individuals Consented. | Baseline (study enrollment) | The number of individuals consented. |
| Refusal After/During Consent Process. | Enrollment | The number of individuals who refuse participation after/during consent process. |
| Mean Sessions Completed | At 8-weeks (post treatment period completion). | The mean number of sessions completed by study participants in the MORE intervention. |
| Baselines Completed | At baseline, | The number of participants who complete baseline assessments. |
| Percentage 8-Weeks Completed | At 8-weeks. | Percentage of participants who completed 8-week assessments. |
| 16-Weeks Completed | At 16-weeks. | The number of participants who completed 16-week assessments. |
| Percentage of 16-Weeks Completed | At 16-weeks. | Percentage of participants who completed 16-week assessments. |
| Number Who Drop Out | At 16 weeks. | Number of participants who drop out of the study. |
| Percentage Who Drop Out | At 16 weeks. | Percentage of participants who drop out of the study. |
| Study Interest | Baseline | The number of individuals who express interest in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days of Illicit Drug Use | 16-weeks | Research staff asked participants if they used various drugs (i.e., heroin, cocaine, opioids, marijuana, amphetamines, inhalants, hallucinogens, benzodiazepines, zolpidem, methylphenidate, or other drugs) in the past 30 days and the number of days of use for each drug in the past 30 days. Days of illicit drug use was determined by counting the number of days each participant used drugs based on past-30 day self-reports at the16-week assessments. |
| Days of Illicit Opioid Use | 16-weeks | Research staff asked participants if they used illicit opioids in the past 30 days and the number of days of use for each drug in the past 30 days. Days of illicit opioid use was determined by counting the number of days each participant used illicit opioids based on past-30 day self-reports at the 16-week assessment. |
| Opioid Craving | 16-weeks | Research staff assessed opioid craving with a version of the Penn Alcohol Craving Scale (PACS; Flannery et al., 1999) that was adapted to assess craving to opioids at 16-weeks. Scores range from 0 to 36. Higher scores indicate greater craving. |
| Pain Level. | 16-weeks | Pain was assess with the pain subscale (i.e., bodily pain severity and interference) of the RAND 36-Item Short Form Health Survey. Scores range from 0 to 100, with higher scores indicating better functioning, health, and well-being and less pain, limitations, and symptom severity or interference as compared to lower scores. |
| Depression Level. | 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. |
| Anxiety Level. | 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 sig-nificant symptoms of anxiety. A higher score on the BAI indicates greater anxiety. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness Oriented Recovery Enhancement 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. | 15 |
| Methadone Program Behavioral Treatment as Usual 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. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Methadone Program Behavioral Treatment as Usual | Mindfulness Oriented Recovery Enhancement | Total |
|---|---|---|---|
| Age, Continuous | 52.9 years STANDARD_DEVIATION 8.4 | 47.9 years STANDARD_DEVIATION 8.7 | 50.4 years STANDARD_DEVIATION 8.8 |
| Anxiety Level. | 39.7 score on a scale STANDARD_DEVIATION 12.3 | 41.7 score on a scale STANDARD_DEVIATION 14.5 | 40.7 score on a scale STANDARD_DEVIATION 13.2 |
| Days of Illicit Drug Use | 25.2 days STANDARD_DEVIATION 29.3 | 24.0 days STANDARD_DEVIATION 17.4 | 24.6 days STANDARD_DEVIATION 23.7 |
| Days of Illicit Opioid Use | 11.7 days STANDARD_DEVIATION 12.8 | 6.4 days STANDARD_DEVIATION 9.2 | 9.1 days STANDARD_DEVIATION 11.3 |
| Depression Level | 23.5 score on a scale STANDARD_DEVIATION 13.4 | 27.2 score on a scale STANDARD_DEVIATION 15.3 | 25.4 score on a scale STANDARD_DEVIATION 14.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 12 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Pain Level | 37.5 score on a scale STANDARD_DEVIATION 23.5 | 28.3 score on a scale STANDARD_DEVIATION 27.6 | 32.9 score on a scale STANDARD_DEVIATION 25.6 |
| 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 | 9 Participants | 7 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 4 Participants | 7 Participants | 11 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 15 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
16-Weeks Completed
The number of participants who completed 16-week assessments.
Time frame: At 16-weeks.
Population: All randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Expressed Interest in the Study | 16-Weeks Completed | 29 Participants |
Primary
8-weeks Completed
The number of participants who complete 8-week assessments.
Time frame: At 8-weeks.
Population: All participants randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Expressed Interest in the Study | 8-weeks Completed | 30 Participants |
Primary
Baselines Completed
The number of participants who complete baseline assessments.
Time frame: At baseline,
Population: All randomized participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Expressed Interest in the Study | Baselines Completed | 30 Participants |
Primary
Individuals Consented.
The number of individuals consented.
Time frame: Baseline (study enrollment)
Population: Eligible individuals.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Expressed Interest in the Study | Individuals Consented. | 31 Participants |
Primary
Individuals Screened
The number of individuals screened and eligible/ineligible.
Time frame: Baseline (study enrollment)
Population: Individuals screened for eligibility.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Expressed Interest in the Study | Individuals Screened | 0 Participants |
Primary
Mean Sessions Completed
The mean number of sessions completed by study participants in the MORE intervention.
Time frame: At 8-weeks (post treatment period completion).
Population: Participants randomized to receive the MORE intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Who Expressed Interest in the Study | Mean Sessions Completed | 6.4 number of sessions | Standard Deviation 3.9 |
Primary
Number Who Drop Out
Number of participants who drop out of the study.
Time frame: At 16 weeks.
Population: Participants enrolled and randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Expressed Interest in the Study | Number Who Drop Out | 0 Participants |
Primary
Percentage 8-Weeks Completed
Percentage of participants who completed 8-week assessments.
Time frame: At 8-weeks.
Population: All randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Who Expressed Interest in the Study | Percentage 8-Weeks Completed | 100 percentage of 8-week assessments. |
Primary
Percentage Baselines Completed
Percentage of people who completed baseline assessments.
Time frame: At baseline,
Population: All randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Who Expressed Interest in the Study | Percentage Baselines Completed | 100 percentage of baseline assessments |
Primary
Percentage of 16-Weeks Completed
Percentage of participants who completed 16-week assessments.
Time frame: At 16-weeks.
Population: All randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Who Expressed Interest in the Study | Percentage of 16-Weeks Completed | 96.7 percentage of 16-week assessments. |
Primary
Percentage of Sessions Completed
The mean percentage of sessions completed by study participants randomized to MORE.
Time frame: At 8-weeks (post treatment period completion).
Population: Participants randomized to MORE
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Who Expressed Interest in the Study | Percentage of Sessions Completed | 76 percentage of sessions | Standard Deviation 0.2 |
Primary
Percentage Who Drop Out
Percentage of participants who drop out of the study.
Time frame: At 16 weeks.
Population: Participants enrolled and randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Who Expressed Interest in the Study | Percentage Who Drop Out | 0 percentage of particpants |
Primary
Refusal After/During Consent Process.
The number of individuals who refuse participation after/during consent process.
Time frame: Enrollment
Population: Individuals who participated in consent process.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Expressed Interest in the Study | Refusal After/During Consent Process. | 1 Participants |
Primary
Study Interest
The number of individuals who express interest in the study.
Time frame: Baseline
Population: Methadone clinic clients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Expressed Interest in the Study | Study Interest | 32 Participants |
Primary
Study Refusal
The number of individuals who who refuse participation when offered.
Time frame: Baseline
Population: Individuals who expressed interest in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Expressed Interest in the Study | Study Refusal | 2 Participants |
Secondary
Anxiety Level.
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 sig-nificant symptoms of anxiety. A higher score on the BAI indicates greater anxiety.
Time frame: 16-weeks
Population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Who Expressed Interest in the Study | Anxiety Level. | 41.05 score on a scale | Standard Deviation 3.09 |
| Methadone Program Behavioral Treatment as Usual | Anxiety Level. | 50.83 score on a scale | Standard Deviation 3.09 |
p-value: 0.035ANOVA
Secondary
Days of Illicit Drug Use
Research staff asked participants if they used various drugs (i.e., heroin, cocaine, opioids, marijuana, amphetamines, inhalants, hallucinogens, benzodiazepines, zolpidem, methylphenidate, or other drugs) in the past 30 days and the number of days of use for each drug in the past 30 days. Days of illicit drug use was determined by counting the number of days each participant used drugs based on past-30 day self-reports at the16-week assessments.
Time frame: 16-weeks
Population: All individuals randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Who Expressed Interest in the Study | Days of Illicit Drug Use | 6.37 days | Standard Deviation 2.76 |
| Methadone Program Behavioral Treatment as Usual | Days of Illicit Drug Use | 15.56 days | Standard Deviation 2.77 |
p-value: 0.048ANOVA
Secondary
Days of Illicit Opioid Use
Research staff asked participants if they used illicit opioids in the past 30 days and the number of days of use for each drug in the past 30 days. Days of illicit opioid use was determined by counting the number of days each participant used illicit opioids based on past-30 day self-reports at the 16-week assessment.
Time frame: 16-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Who Expressed Interest in the Study | Days of Illicit Opioid Use | 2.47 days | Standard Deviation 0.97 |
| Methadone Program Behavioral Treatment as Usual | Days of Illicit Opioid Use | 5.49 days | Standard Deviation 0.97 |
p-value: 0.037ANCOVA
Secondary
Depression Level.
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 |
|---|---|---|---|
| Participants Who Expressed Interest in the Study | Depression Level. | 34.11 score on a scale | Standard Deviation 2.31 |
| Methadone Program Behavioral Treatment as Usual | Depression Level. | 42.93 score on a scale | Standard Deviation 2.34 |
p-value: 0.013ANOVA
Secondary
Opioid Craving
Research staff assessed opioid craving with a version of the Penn Alcohol Craving Scale (PACS; Flannery et al., 1999) that was adapted to assess craving to opioids at 16-weeks. Scores range from 0 to 36. Higher scores indicate greater craving.
Time frame: 16-weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Who Expressed Interest in the Study | Opioid Craving | 15.52 score on a scale | Standard Deviation 1.71 |
| Methadone Program Behavioral Treatment as Usual | Opioid Craving | 21.35 score on a scale | Standard Deviation 1.72 |
p-value: 0.024ANCOVA
Secondary
Pain Level.
Pain was assess with the pain subscale (i.e., bodily pain severity and interference) of the RAND 36-Item Short Form Health Survey. Scores range from 0 to 100, with higher scores indicating better functioning, health, and well-being and less pain, limitations, and symptom severity or interference as compared to lower scores.
Time frame: 16-weeks
Population: All randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Who Expressed Interest in the Study | Pain Level. | 50.76 score on a scale | Standard Deviation 5.52 |
| Methadone Program Behavioral Treatment as Usual | Pain Level. | 26.65 score on a scale | Standard Deviation 5.54 |
p-value: 0.005ANCOVA