Back to resultsMinds and Mentors Program- R33 (MiMP)
Primary Purpose
Opioid Use Disorder, Substance Use Disorders, Medication Assisted Treatment
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Minds and Mentors
Twelve Step Intervention Group
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Use Disorder focused on measuring Opioid Use Disorder, Mindfulness based therapy, Cravings, Relapse prevention, Treatment retention, Depression, Stress, Anxiety, Cortisol, Peer Mentors
Eligibility Criteria
Inclusion Criteria:
- Age 19 and older
- Opioid Use disorder diagnosis based on DSM-V criteria in the past 30 days
- Currently receiving MOUD (e.g. methadone, naloxone, naltrexone, and buprenorphine) from an established provider
- Are within maintenance phase of MOUD (not actively detoxing)
- May meet criteria for a mood, anxiety, or other psychiatric disorder based on the DSM-V criteria. Participants on maintenance medications for a mood or anxiety disorder must be stabilized on medications for at least 2 weeks before therapy initiation
- Capable of reading and understanding English
- Able to provide written informed consent (i.e. no surrogate)
- Access to a smartphone or a computer with an internet connection
- Willing to commit to 12 group therapy sessions, baseline, and follow-up assessments for 24 weeks after the end of treatment (9- month total)
Exclusion Criteria:
- Significant cognitive impairment
- Women who are pregnant (does not impact eligibility post study initiation)
- Actively suicidal or homicidal
- Active psychosis and/ or
- Unstable medical conditions that contraindicate proposed treatment
Subject Exit criteria:
- Increases in alcohol or drug use leading to the need for a more intensive level of care (i.e., medical detoxification, inpatient)
- Newly developed active suicidal or homicidal ideation
- Inability to manage psychiatric symptoms within the inclusion/exclusion criteria of the study (i.e., need for the initiation of maintenance psychotropic medications; development of psychosis). If it is determined, based on clinical criteria, that a participant needs to be started on maintenance medications for anxiety, mood or psychotic symptoms during the study, they will be discontinued from the treatment trial
- Inability to return for therapy sessions for four consecutive weeks.
Sites / Locations
- Birmingham Veteran Affairs Medical CenterRecruiting
- Pathway Healthcare, LLCRecruiting
- Tuscaloosa Veteran Affairs Medical CenterRecruiting
- University of AlabamaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness based relapse prevention and peer mentoring
12 Step Treatment Program
Arm Description
Treatment will utilize a group format. The twelve-week mindfulness based relapsed prevention group therapy intervention is co-led by a licensed counselor and a peer mentor for eight weeks, followed by group sessions led by peer mentors for an additional four weeks.
Participants in the attentional control group will attend 12 weeks of a enhanced 12 step treatment program.
Outcomes
Primary Outcome Measures
Adherence Rate
Adherence rate operationalized as number of weeks a participant continually receives MOUD as prescribed by primary provider for the duration of the intervention and follow-up period
Secondary Outcome Measures
Relapse
Relapse as measured through both self-report utilizing the Timeline Follow-Back (TLFB) and Urine Drug Screen (UDS). The TLFB is a structured interview using calendar-based anchors to assess weekly drug use. UDS is a weekly urine dipstick for substance use; the urine cup has a multi-drug 12 panel test on the cup's surface, which detects several substances including opiates, and uses concentrations levels established by SAMSHA. A participant will be coded as positive for use (i.e., having relapsed) if: (a) the participant self-reported use for that week; or (b) the participant denied use, but provided a positive urine drug screen for opioids. Relapse will be ascertained in 30-day periods. At baseline, a Timeline Followback (TLFB)8 for the 30 days before admission will be obtained (with opioid use separated from other drug use) and a urine drug screen collected. For follow-up assessments, the TLFB for the previous 60 days, 3 months, 3 months post and 6 months post will be obtained.
Cravings
Cravings as measured by the Opioid Craving Scale (OCS), a modification of the Cocaine Craving Scale will be utilized to assess opioid craving. The OCS consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates). The total score is calculated by averaging the three items.
Depression
Depression as measured by the Patient Health Questionnaire (PHQ-9), a 9-item self-report that measures depressive symptoms
Stress
Stress as measured by the Perceived Stress Scale (PSS), a 10-item self-report of perceived stress
Anxiety
Anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7), a 7-item self-report of anxiety
Quality of Life
Quality of life as measured by the PROMIS Physical Functioning/ Quality of Life, a 6-item self report of physical functioning and quality of life
Full Information
NCT ID
NCT05363371
First Posted
May 2, 2022
Last Updated
July 25, 2022
Sponsor
University of Alabama, Tuscaloosa
Collaborators
University of Alabama at Birmingham, Tuscaloosa Veterans Affairs Medical Center, Pathway Healthcare, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05363371
Brief Title
Minds and Mentors Program- R33
Acronym
MiMP
Official Title
A Mindfulness and Peer Mentoring Program to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R33 Phase)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama, Tuscaloosa
Collaborators
University of Alabama at Birmingham, Tuscaloosa Veterans Affairs Medical Center, Pathway Healthcare, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The proposed research effort will:
The purpose of this study is as follows:
Test the effectiveness of the Minds and Mentors Program in a group treatment trial in which individuals using medications for opioid use disorder (MOUD) will be randomized in blocks of five to receive either the Minds and Mentors Program (n=120) or Twelve Step Facilitation (n=120).
Determine whether the MiMP: a) improves adherence to MOUD b) reduces the rate of relapse and cravings c) decreases self-reported anxiety, stress, and depression and d) reduces cortisol levels and cortisol reactivity to drug cues.
Examine whether pre-intervention cortisol reactivity is predictive of relapse outcomes, and/ or reductions in cortisol reactivity over the course of intervention mediate relapse outcomes.
Detailed Description
Although medications for opioid use disorders (MOUD) is safe and effective and is currently considered the gold standard for treating OUD, adherence to MOUD regimens remains a challenge. Early studies have demonstrated efficacy of mindfulness-based interventions as adjunctive treatment for substance use disorders (SUD) while reducing substance use and cravings. In addition, non-randomized pilot studies suggest that mindfulness-based interventions may be effective in reducing symptoms of depression and anxiety in individuals undergoing MOUD.
The goal of the proposed study is to determine the effectiveness of a mindfulness-based intervention that also utilizes peer mentors in addition to professional substance abuse therapists (the Minds and Mentors program [MiMP]) in improving adherence to MOUD and reducing relapse rates in a sample of individuals with OUD who are also on MOUD versus a twelve-step facilitation (TSF) program. The MiMP is a twelve-week intervention that uses group therapy and meets once a week for about two hours. The primary outcome measure will is adherence to medications for OUD. The secondary outcome measures will include the demographic covariates, depression, anxiety, stress, quality of life, and cravings. Finally, exploratory outcome measures will include cortisol levels and rates of reactivity to drug cues. This study will randomize participants in either intervention or control group in blocks of five. Data collection will occur at baseline, 8 weeks, 12 weeks (end of treatment) and at 12- week and 24- week follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Substance Use Disorders, Medication Assisted Treatment
Keywords
Opioid Use Disorder, Mindfulness based therapy, Cravings, Relapse prevention, Treatment retention, Depression, Stress, Anxiety, Cortisol, Peer Mentors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness based relapse prevention and peer mentoring
Arm Type
Experimental
Arm Description
Treatment will utilize a group format. The twelve-week mindfulness based relapsed prevention group therapy intervention is co-led by a licensed counselor and a peer mentor for eight weeks, followed by group sessions led by peer mentors for an additional four weeks.
Arm Title
12 Step Treatment Program
Arm Type
Active Comparator
Arm Description
Participants in the attentional control group will attend 12 weeks of a enhanced 12 step treatment program.
Intervention Type
Behavioral
Intervention Name(s)
Minds and Mentors
Intervention Description
Participants will be randomized into Minds and Mentors to attend weekly group therapy sessions for 12 week. The mindfulness-based relapse prevention therapy intervention will be led by a licensed counselor for eights weeks followed up by four additional sessions led by a certified recovery support specialist (peer mentor).
Intervention Type
Behavioral
Intervention Name(s)
Twelve Step Intervention Group
Intervention Description
Participants will be randomized to the Twelve Step Intervention Group to attend weekly group therapy sessions for 12 week. The twelve step intervention group will be led by a licensed counselor.
Primary Outcome Measure Information:
Title
Adherence Rate
Description
Adherence rate operationalized as number of weeks a participant continually receives MOUD as prescribed by primary provider for the duration of the intervention and follow-up period
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Relapse
Description
Relapse as measured through both self-report utilizing the Timeline Follow-Back (TLFB) and Urine Drug Screen (UDS). The TLFB is a structured interview using calendar-based anchors to assess weekly drug use. UDS is a weekly urine dipstick for substance use; the urine cup has a multi-drug 12 panel test on the cup's surface, which detects several substances including opiates, and uses concentrations levels established by SAMSHA. A participant will be coded as positive for use (i.e., having relapsed) if: (a) the participant self-reported use for that week; or (b) the participant denied use, but provided a positive urine drug screen for opioids. Relapse will be ascertained in 30-day periods. At baseline, a Timeline Followback (TLFB)8 for the 30 days before admission will be obtained (with opioid use separated from other drug use) and a urine drug screen collected. For follow-up assessments, the TLFB for the previous 60 days, 3 months, 3 months post and 6 months post will be obtained.
Time Frame
9 months
Title
Cravings
Description
Cravings as measured by the Opioid Craving Scale (OCS), a modification of the Cocaine Craving Scale will be utilized to assess opioid craving. The OCS consists of three items rated on a visual analogue scale from 0-10: (1) How much do you currently crave opiates? (rated from not at all to extremely), (2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates (rated from no desire to extremely strong), and (3) Please imagine yourself in the environment in which you previously used opiates. If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today? (rated from not at all to I'm sure I would use opiates). The total score is calculated by averaging the three items.
Time Frame
9 months
Title
Depression
Description
Depression as measured by the Patient Health Questionnaire (PHQ-9), a 9-item self-report that measures depressive symptoms
Time Frame
9 months
Title
Stress
Description
Stress as measured by the Perceived Stress Scale (PSS), a 10-item self-report of perceived stress
Time Frame
9 months
Title
Anxiety
Description
Anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7), a 7-item self-report of anxiety
Time Frame
9 months
Title
Quality of Life
Description
Quality of life as measured by the PROMIS Physical Functioning/ Quality of Life, a 6-item self report of physical functioning and quality of life
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
Cortisol Reactivity
Description
Cortisol reactivity to drug cues as measured by non-invasive salivary cortisol levels. Non-invasive salivary cortisol levels will be assessed as a measure of stress reactivity to cues at baseline, post-treatment, and follow-up time points. Two samples will be acquired at each assessment session to represent resting baseline cortisol levels, stress induced cortisol levels to drug-related cues, and return to rest levels. To minimize diurnal cycle effects, assessment will take place in the afternoon when cortisol is lower, and reactivity can be detected. After 20 minutes at rest, five mL of saliva will be collected via the passive drool. Next, participants will watch a 20-minute video depicting drug cues. A second sample will then be collected to assess cortisol reactivity to drug cues. Participants will be asked to rate the extent of high, craving, and withdrawal feelings using a 10-point scale. Samples will be transported in coolers to Dr. Glenn's lab where they will be immediately
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 19 and older
Opioid Use disorder diagnosis based on DSM-V criteria in the past 30 days
Currently receiving MOUD (e.g. methadone, naloxone, naltrexone, and buprenorphine) from an established provider
Are within maintenance phase of MOUD (not actively detoxing)
May meet criteria for a mood, anxiety, or other psychiatric disorder based on the DSM-V criteria. Participants on maintenance medications for a mood or anxiety disorder must be stabilized on medications for at least 2 weeks before therapy initiation
Capable of reading and understanding English
Able to provide written informed consent (i.e. no surrogate)
Access to a smartphone or a computer with an internet connection
Willing to commit to 12 group therapy sessions, baseline, and follow-up assessments for 24 weeks after the end of treatment (9- month total)
Exclusion Criteria:
Significant cognitive impairment
Women who are pregnant (does not impact eligibility post study initiation)
Actively suicidal or homicidal
Active psychosis and/ or
Unstable medical conditions that contraindicate proposed treatment
Subject Exit criteria:
Increases in alcohol or drug use leading to the need for a more intensive level of care (i.e., medical detoxification, inpatient)
Newly developed active suicidal or homicidal ideation
Inability to manage psychiatric symptoms within the inclusion/exclusion criteria of the study (i.e., need for the initiation of maintenance psychotropic medications; development of psychosis). If it is determined, based on clinical criteria, that a participant needs to be started on maintenance medications for anxiety, mood or psychotic symptoms during the study, they will be discontinued from the treatment trial
Inability to return for therapy sessions for four consecutive weeks.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mercy N Mumba, PhD
Phone
682-521-0423
Email
mnmumba@ua.edu
Facility Information:
Facility Name
Birmingham Veteran Affairs Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sierra Rodgers-Farris
Email
sierra.rodgers-farris@va.gov
First Name & Middle Initial & Last Name & Degree
Joshua Richman, PhD
Facility Name
Pathway Healthcare, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Turner
Phone
205-495-7939
Email
aturner@pathwayhealthcare.com
First Name & Middle Initial & Last Name & Degree
Anita Giannaris
Phone
251-214-0040
Email
agiannaris.mobile@pathwayhealthcare.com
Facility Name
Tuscaloosa Veteran Affairs Medical Center
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Davis, M.D.
Email
lori.davis@va.gov
First Name & Middle Initial & Last Name & Degree
Sierra Rodgers-Farris
Phone
205-554-2000
Ext
4138
Email
sierra.rodgers-farris@va.gov
First Name & Middle Initial & Last Name & Degree
Mary L Jacobs, PhD
Facility Name
University of Alabama
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35487
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mercy N Mumba, PhD
Phone
682-521-0423
Email
mnmumba@ua.edu
First Name & Middle Initial & Last Name & Degree
Austin Butler, MPA
Phone
2053485733
Email
abutler13@ua.edu
First Name & Middle Initial & Last Name & Degree
George Mugoya, PhD
First Name & Middle Initial & Last Name & Degree
Andrea Glenn, PhD
First Name & Middle Initial & Last Name & Degree
Rebecca Allen, PhD
First Name & Middle Initial & Last Name & Degree
David Albright, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Minds and Mentors Program- R33
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