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Completed

NCT Number: NCT04491968

Mindfulness Oriented Recovery Enhancement for Chronic Pain and Opioid Relapse

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.

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Key information

Conditions

Opioid Use Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness Oriented Recovery Enhancement

Behavioral

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

Methadone Treatment as usual

Other

In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.

Other names: MMT, Treatment as Usual, TAU

Primary outcomes

  1. Drug Relapse Through 16-weeks.

    Time frame: 16-weeks

    Drug use as measured by self-report through EMA, follow-back, or urine screen.

  2. Methadone Treatment Drop Out Through 16-weeks.

    Time frame: 16-weeks

    Methadone treatment drop out as measured by clinic report.

Secondary outcomes

  1. Number of Days of Any Drug Use

    Time frame: 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.

  2. Number of Days of Opioid Use.

    Time frame: 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.

  3. Number of Days of Other Drug Use.

    Time frame: 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.

  4. Changes in Craving

    Time frame: 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) .

  5. Changes in Pain.

    Time frame: 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.

  6. Changes in Depression.

    Time frame: 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.

  7. Changes in Anxiety.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • University of Utah

Registry information

Official study title

Mindfulness Oriented Recovery Enhancement for Chronic Pain and Opioid Relapse as an Adjunct to Methadone Treatment

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 30, 2020
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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