Pilot of Mindfulness Oriented Recovery Enhancement in MethadoneTreatment

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Completed
• CT.gov ID: NCT03894501
• Collaborator: University of Utah (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.6
• Patients Per Site Per Month: 6.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Opioid Use; Chronic Pain	Behavioral: Mindfulness Oriented Recovery Enhancement; Behavioral: Methadone program behavioral treatment as usual	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two-arm randomized controlled trial.Two-arm randomized controlled trial.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use and Chronic Pain Management Pilot
• Actual Study Start Date: Jan 31, 2019
• Actual Primary Completion Date: Jun 19, 2019
• Actual Study Completion Date: Jun 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Mindfulness Oriented Recovery Enhancement; 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.; Other Names: MORE
Other: 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.	Behavioral: 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.; Other Names: Treatment as Usual, TAU

Outcome Measures

Primary Outcome Measures

1. Study Interest [Baseline]

   The number of individuals who express interest in the study.

2. Study Refusal [Baseline]

   The number of individuals who who refuse participation when offered.

3. Individuals Screened [Baseline (study enrollment)]

   The number of individuals screened and eligible/ineligible.

4. Individuals Consented. [Baseline (study enrollment)]

   The number of individuals consented.

5. Refusal After/During Consent Process. [Enrollment]

   The number of individuals who refuse participation after/during consent process.

6. Mean Sessions Completed [At 8-weeks (post treatment period completion).]

   The mean number of sessions completed by study participants in the MORE intervention.

7. Percentage of Sessions Completed [At 8-weeks (post treatment period completion).]

   The mean percentage of sessions completed by study participants randomized to MORE.

8. Number Who Drop Out [At 16 weeks.]

   Number of participants who drop out of the study.

9. Percentage Who Drop Out [At 16 weeks.]

   Percentage of participants who drop out of the study.

10. Baselines Completed [At baseline,]

    The number of participants who complete baseline assessments.

11. Percentage Baselines Completed [At baseline,]

    Percentage of people who completed baseline assessments.

12. 8-weeks Completed [At 8-weeks.]

    The number of participants who complete 8-week assessments.

13. Percentage 8-Weeks Completed [At 8-weeks.]

    Percentage of participants who completed 8-week assessments.

14. 16-Weeks Completed [At 16-weeks.]

    The number of participants who completed 16-week assessments.

15. Percentage of 16-Weeks Completed [At 16-weeks.]

    Percentage of participants who completed 16-week assessments.

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08901

Sponsors and Collaborators

• Rutgers, The State University of New Jersey
• University of Utah

Investigators

• Principal Investigator: Nina A Cooperman, PsyD, Rutgers Robert Wood Johnson Medical School

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 24, 2021

More Information

Publications

None provided.

• Responsible Party: Nina A. Cooperman, Psy. D., Associate Professor, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT03894501
• Other Study ID Numbers: 2018001127
• First Posted: Mar 28, 2019
• Last Update Posted: Jan 11, 2022
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nina A. Cooperman, Psy. D., Associate Professor, Rutgers, The State University of New Jersey: opioid; chronic pain; methadone; mindfulness
• Additional relevant MeSH terms: Chronic Pain; Methadone

Study Results

Participant Flow

Arm/Group Title	Mindfulness Oriented Recovery Enhancement	Methadone Program Behavioral Treatment as Usual
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Mindfulness Oriented Recovery Enhancement	Methadone Program Behavioral Treatment as Usual	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	15	15	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.9 (8.7)	52.9 (8.4)	50.4 (8.8)
Sex: Female, Male (Count of Participants)
Female	8 53.3%	7 46.7%	15 50%
Male	7 46.7%	8 53.3%	15 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 20%	3 20%	6 20%
Not Hispanic or Latino	12 80%	12 80%	24 80%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 46.7%	9 60%	16 53.3%
White	7 46.7%	4 26.7%	11 36.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 6.7%	2 13.3%	3 10%
Region of Enrollment (participants) [Number]
United States	15 100%	15 100%	15 50%
Days of Illicit Drug Use (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	24.0 (17.4)	25.2 (29.3)	24.6 (23.7)
Days of Illicit Opioid Use (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	6.4 (9.2)	11.7 (12.8)	9.1 (11.3)
Pain Level (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	28.3 (27.6)	37.5 (23.5)	32.9 (25.6)
Depression Level (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	27.2 (15.3)	23.5 (13.4)	25.4 (14.2)
Anxiety Level. (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	41.7 (14.5)	39.7 (12.3)	40.7 (13.2)

Outcome Measures

1. Primary Outcome

Title	Study Interest
Description	The number of individuals who express interest in the study.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Methadone clinic clients.

Arm/Group Title	Participants Who Expressed Interest in the Study
Arm/Group Description	Individuals who asked for information on the study or who asked to be screened for eligibility.
Measure Participants	32
Count of Participants [Participants]	32 213.3%

2. Primary Outcome

Title	Study Refusal
Description	The number of individuals who who refuse participation when offered.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Individuals who expressed interest in the study.

Arm/Group Title	The Number of Individuals Who Who Refuse Study Participation When Offered.
Arm/Group Description	The number of individuals who who refuse study participation when offered.
Measure Participants	32
Count of Participants [Participants]	2 13.3%

3. Primary Outcome

Title	Individuals Screened
Description	The number of individuals screened and eligible/ineligible.
Time Frame	Baseline (study enrollment)

Outcome Measure Data

Analysis Population Description

Individuals screened for eligibility.

Arm/Group Title	The Number of Individuals Screened and Ineligible.
Arm/Group Description	The number of individuals screened and ineligible.
Measure Participants	32
Count of Participants [Participants]	0 0%

4. Primary Outcome

Title	Individuals Consented.
Description	The number of individuals consented.
Time Frame	Baseline (study enrollment)

Outcome Measure Data

Analysis Population Description

Eligible individuals.

Arm/Group Title	The Number of Eligible Participants Consented
Arm/Group Description	The number of eligible individuals consented.
Measure Participants	32
Count of Participants [Participants]	31 206.7%

5. Primary Outcome

Title	Refusal After/During Consent Process.
Description	The number of individuals who refuse participation after/during consent process.
Time Frame	Enrollment

Outcome Measure Data

Analysis Population Description

Individuals who participated in consent process.

Arm/Group Title	The Number of Individuals Who Refuse Participation After/During Consent Process.
Arm/Group Description	The number of individuals who refuse participation after/during consent process.
Measure Participants	31
Count of Participants [Participants]	1 6.7%

6. Primary Outcome

Title	Mean Sessions Completed
Description	The mean number of sessions completed by study participants in the MORE intervention.
Time Frame	At 8-weeks (post treatment period completion).

Outcome Measure Data

Analysis Population Description

Participants randomized to receive the MORE intervention.

Arm/Group Title	The Mean Number of Sessions Completed by Study Participants in the MORE Intervention.
Arm/Group Description	The mean number of sessions completed by study participants in the MORE intervention.
Measure Participants	15
Mean (Standard Deviation) [number of sessions]	6.4 (3.9)

7. Primary Outcome

Title	Percentage of Sessions Completed
Description	The mean percentage of sessions completed by study participants randomized to MORE.
Time Frame	At 8-weeks (post treatment period completion).

Outcome Measure Data

Analysis Population Description

Participants randomized to MORE

Arm/Group Title	The Mean Percentage of Sessions Completed by Study Participants Randomized to MORE.
Arm/Group Description	The mean percentage of sessions completed by study participants randomized to MORE.
Measure Participants	15
Mean (Standard Deviation) [percentage of sessions]	76 (.20)

8. Primary Outcome

Title	Number Who Drop Out
Description	Number of participants who drop out of the study.
Time Frame	At 16 weeks.

Outcome Measure Data

Analysis Population Description

Participants enrolled and randomized.

Arm/Group Title	Number of Participants Who Dropped Out of the Study.
Arm/Group Description	Number of participants who dropped out of the study.
Measure Participants	30
Count of Participants [Participants]	0 0%

9. Primary Outcome

Title	Percentage Who Drop Out
Description	Percentage of participants who drop out of the study.
Time Frame	At 16 weeks.

Outcome Measure Data

Analysis Population Description

Participants enrolled and randomized.

Arm/Group Title	Percentage of Participants Who Dropped Out of the Study.
Arm/Group Description	Percentage of participants who dropped out of the study.
Measure Participants	30
Number [percentage of particpants]	0

10. Primary Outcome

Title	Baselines Completed
Description	The number of participants who complete baseline assessments.
Time Frame	At baseline,

Outcome Measure Data

Analysis Population Description

All randomized participants.

Arm/Group Title	Baselines Completed
Arm/Group Description	The number of people who completed baseline assessments.
Measure Participants	30
Count of Participants [Participants]	30 200%

11. Primary Outcome

Title	Percentage Baselines Completed
Description	Percentage of people who completed baseline assessments.
Time Frame	At baseline,

Outcome Measure Data

Analysis Population Description

All randomized participants.

Arm/Group Title	Percentage Baselines Completed
Arm/Group Description	The percentage of people who completed baseline assessments.
Measure Participants	30
Number [percentage of baseline assessments]	100

12. Primary Outcome

Title	8-weeks Completed
Description	The number of participants who complete 8-week assessments.
Time Frame	At 8-weeks.

Outcome Measure Data

Analysis Population Description

All participants randomized.

Arm/Group Title	8-weeks Completed
Arm/Group Description	The number of participants who completed 8-week assessments.
Measure Participants	30
Count of Participants [Participants]	30 200%

13. Primary Outcome

Title	Percentage 8-Weeks Completed
Description	Percentage of participants who completed 8-week assessments.
Time Frame	At 8-weeks.

Outcome Measure Data

Analysis Population Description

All randomized participants.

Arm/Group Title	Percentage 8-weeks Completed
Arm/Group Description	The percentage of participants who completed 8-week assessments.
Measure Participants	30
Number [percentage of 8-week assessments.]	100

14. Primary Outcome

Title	16-Weeks Completed
Description	The number of participants who completed 16-week assessments.
Time Frame	At 16-weeks.

Outcome Measure Data

Analysis Population Description

All randomized participants.

Arm/Group Title	16-Weeks Completed
Arm/Group Description	The number of participants who completed 16-week assessments.
Measure Participants	30
Count of Participants [Participants]	29 193.3%

15. Primary Outcome

Title	Percentage of 16-Weeks Completed
Description	Percentage of participants who completed 16-week assessments.
Time Frame	At 16-weeks.

Outcome Measure Data

Analysis Population Description

All randomized participants.

Arm/Group Title	Percentage of 16-weeks Completed
Arm/Group Description	The percentage of participants who completed 16-week assessments.
Measure Participants	30
Number [percentage of 16-week assessments.]	96.7

16. Secondary Outcome

Title	Days of Illicit Drug Use
Description	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

Outcome Measure Data

Analysis Population Description

All individuals randomized.

Arm/Group Title	Mindfulness Oriented Recovery Enhancement	Methadone Program Behavioral Treatment as Usual
Arm/Group Description	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.	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.
Measure Participants	15	15
Mean (Standard Deviation) [days]	6.37 (2.76)	15.56 (2.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Participants Who Expressed Interest in the Study, Methadone Program Behavioral Treatment as Usual
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.048
	Comments
	Method	ANOVA
	Comments

17. Secondary Outcome

Title	Days of Illicit Opioid Use
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness Oriented Recovery Enhancement	Methadone Program Behavioral Treatment as Usual
Arm/Group Description	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.	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.
Measure Participants	15	15
Mean (Standard Deviation) [days]	2.47 (.97)	5.49 (.97)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Participants Who Expressed Interest in the Study, Methadone Program Behavioral Treatment as Usual
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.037
	Comments
	Method	ANCOVA
	Comments

18. Secondary Outcome

Title	Opioid Craving
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness Oriented Recovery Enhancement	Methadone Program Behavioral Treatment as Usual
Arm/Group Description	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.	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.
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	15.52 (1.71)	21.35 (1.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Participants Who Expressed Interest in the Study, Methadone Program Behavioral Treatment as Usual
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.024
	Comments
	Method	ANCOVA
	Comments

19. Secondary Outcome

Title	Pain Level.
Description	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

Outcome Measure Data

Analysis Population Description

All randomized participants.

Arm/Group Title	Mindfulness Oriented Recovery Enhancement	Methadone Program Behavioral Treatment as Usual
Arm/Group Description	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.	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.
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	50.76 (5.52)	26.65 (5.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Participants Who Expressed Interest in the Study, Methadone Program Behavioral Treatment as Usual
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.005
	Comments
	Method	ANCOVA
	Comments

20. Secondary Outcome

Title	Depression Level.
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness Oriented Recovery Enhancement	Methadone Program Behavioral Treatment as Usual
Arm/Group Description	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.	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.
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	34.11 (2.31)	42.93 (2.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Participants Who Expressed Interest in the Study, Methadone Program Behavioral Treatment as Usual
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.013
	Comments
	Method	ANOVA
	Comments

21. Secondary Outcome

Title	Anxiety Level.
Description	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

Outcome Measure Data

Analysis Population Description

All randomized participants.

Arm/Group Title	Mindfulness Oriented Recovery Enhancement	Methadone Program Behavioral Treatment as Usual
Arm/Group Description	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.	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.
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	41.05 (3.09)	50.83 (3.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Participants Who Expressed Interest in the Study, Methadone Program Behavioral Treatment as Usual
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.035
	Comments
	Method	ANOVA
	Comments

Adverse Events

Time Frame	16-weeks
Arm/Group Title	Mindfulness Oriented Recovery Enhancement		Methadone Program Behavioral Treatment as Usual
Arm/Group Description	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.		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.
All Cause Mortality
	Mindfulness Oriented Recovery Enhancement		Methadone Program Behavioral Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Serious Adverse Events
	Mindfulness Oriented Recovery Enhancement		Methadone Program Behavioral Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Mindfulness Oriented Recovery Enhancement		Methadone Program Behavioral Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.