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Pilot of Mindfulness Oriented Recovery Enhancement in MethadoneTreatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03894501
Recruitment Status : Active, not recruiting
First Posted : March 28, 2019
Last Update Posted : April 15, 2019
Sponsor:
Collaborator:
University of Utah
Information provided by (Responsible Party):
Nina A. Cooperman, Psy. D., Rutgers, The State University of New Jersey

Tracking Information
First Submitted Date  ICMJE March 26, 2019
First Posted Date  ICMJE March 28, 2019
Last Update Posted Date April 15, 2019
Actual Study Start Date  ICMJE January 31, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2019)
  • The number of individuals who express interest in the study. [ Time Frame: Baseline ]
    The number of individuals who express interest in the study.
  • The number of individuals who who refuse study participation when offered. [ Time Frame: Baseline ]
    The number of individuals who who refuse participation when offered.
  • The number of individuals screened and eligible/ineligible. [ Time Frame: Baseline (study enrollment) ]
    The number of individuals screened and eligible/ineligible.
  • The number of individuals consented. [ Time Frame: Baseline (study enrollment) ]
    The number of individuals consented.
  • The number of individuals who refuse participation after/during consent process. [ Time Frame: Enrollment ]
    The number of individuals who refuse participation after/during consent process.
  • The number of sessions completed by study participants. [ Time Frame: At 8-weeks (post treatment period completion). ]
    The number of sessions completed by study participants.
  • The percentage of sessions completed by study participants. [ Time Frame: At 8-weeks (post treatment period completion). ]
    The percentage of sessions completed by study participants.
  • Number of participants who drop out of the study. [ Time Frame: At 16 weeks. ]
    Number of participants who drop out of the study.
  • Percentage of participants who drop out of the study. [ Time Frame: At 16 weeks. ]
    Percentage of participants who drop out of the study.
  • The number of completed/missed assessments. [ Time Frame: At baseline, ]
    The number of completed/missed assessments.
  • Percentage of completed/missed assessments. [ Time Frame: At baseline, ]
    Percentage of completed/missed assessments.
  • The number of completed/missed assessments. [ Time Frame: At 8-weeks. ]
    The number of completed/missed assessments.
  • Percentage of completed/missed assessments. [ Time Frame: At 8-weeks. ]
    Percentage of completed/missed assessments.
  • The number of completed/missed assessments. [ Time Frame: At 16-weeks. ]
    The number of completed/missed assessments.
  • Percentage of completed/missed assessments. [ Time Frame: At 16-weeks. ]
    Percentage of completed/missed assessments.
  • The number of completed/missed EMA assessments. [ Time Frame: Over 16 weeks. ]
    The number of completed/missed EMA assessments.
  • Percentage of completed/missed EMA assessments. [ Time Frame: Over 16 weeks. ]
    Percentage of completed/missed EMA assessments.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03894501 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot of Mindfulness Oriented Recovery Enhancement in MethadoneTreatment
Official Title  ICMJE Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use and Chronic Pain Management Pilot
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two-arm randomized controlled trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Opioid Use
  • Chronic Pain
Intervention  ICMJE
  • 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 Name: MORE
  • 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 Name: Treatment as Usual, TAU
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Mindfulness Oriented Recovery Enhancement
  • 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.
    Intervention: Behavioral: Methadone program behavioral treatment as usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 27, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03894501
Other Study ID Numbers  ICMJE 2018001127
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Analyses of data generated from this project will be shared with the scientific community through publications in peer-reviewed journals and presentations at scientific meetings. The proposed research will include data from approximately 30 individuals in methadone maintenance treatment. The final dataset will include self-reported demographic and behavioral data from interviews with the subjects and laboratory data from urine specimens provided. Because we will be following study participants, we will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Beginning 3 months and ending 36 months after study publication.
Access Criteria: We will make the data and associated documentation available to research community scientists only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Responsible Party Nina A. Cooperman, Psy. D., Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE University of Utah
Investigators  ICMJE
Principal Investigator: Nina A Cooperman, PsyD Rutgers Robert Wood Johnson Medical School
PRS Account Rutgers, The State University of New Jersey
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP