Clinical trial NCT05042388: Mindfulness-Based Relapse Prevention to Improve Medication Assisted Treatment Adherence and Drug-use Outcomes for Opioid Use Disorder
Official title: Mindful MAT Adherence: Mindfulness-Based Relapse Prevention (MBRP) to Improve Extended-release Naltrexone (XR-NTX) Adherence and Drug-use Outcomes for Opioid Use Disorder (OUD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Keywords: Addiction
Relapse Prevention
Opioid
Mindfulness
Lead sponsor: West Chester University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-09-13
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to 1 of 2 conditions: MBRP+TAU or TAU.
Primary purpose: TREATMENT

Brief summary: This proposal aims to determine whether an adjunctive Mindfulness-Based Relapse Prevention (MBRP) treatment program improves Medication Assisted Treatment (MAT) adherence and reduces drug-use among opioid use disorder (OUD) patients. The broad long-term objectives of this project are to investigate how integrative pharmacological and behavioral treatments improve OUD treatment outcomes. Participants for this study will include 200 patients diagnosed with opioid use disorder (OUD), that are enrolled in a 60-day residential addiction treatment program and prescribed MAT for OUD. Participants will be randomly assigned to a MBRP behavioral treatment condition or a non-MBRP treatment-as-usual (TAU) control condition as part of their treatment within the residential addiction treatment program. All participants will be monitored for three-months following their discharge from the program to test the hypotheses that MBRP participants, relative to TAU participants, will (1) demonstrate greater MAT adherence following discharge, and (2) evidence reduced drug-use following discharge.

Detailed description: Medically detoxified OUD patients enrolling into a 60-day residential program will be randomized to either MAT Treatment-As-Usual (TAU; n=100) or TAU+MBRP (MBRP; n=100) as part of their residential treatment and followed for 3-months post-discharge to assess MAT adherence and drug-use. All participants (n=200) will participate in residential TAU (i.e., MAT, supportive group therapy), will be scheduled monthly MAT appointments per discharge treatment procedures, and will complete assessments at baseline, post- treatment, and 1-, 2-, and 3-month follow-ups. Study Aims include:

AIM 1 (PRIMARY): Compare impact of TAU versus TAU+MBRP on medication adherence and drug-use outcomes. Hypotheses: Relative to TAU, TAU+MBRP participants will demonstrate a) greater MAT adherence measured at follow-up timepoints, and b) reduced drug-use (i.e., self-report, urine drug-screens \[UDS\]) measured at discharge and follow-up timepoints. AIM 2: Determine whether the beneficial effects of TAU+MBRP on outcome are mediated by improvements in opioid craving and dispositional mindfulness. Hypotheses: TAU+MBRP participants will report greater improvements in distress tolerance and mindfulness, relative to TAU, which will mediate treatment outcomes (i.e., MAT adherence, reduced drug use and positive-UDS). EXPLORATORY AIM 3: Determine effects of baseline factors on treatment outcomes. Hypotheses: More severe trauma exposure (i.e., increased number of traumas) and greater posttraumatic stress symptom severity will result in poorer treatment adherence (i.e., reduced MAT follow-up appointments) and worse drug-use outcomes (i.e., increased self-reported drug use, positive-urine drug-screens) throughout each the follow-up assessments among TAU participants but not among MBRP participants.

Study Design Overview: In an randomized controlled trial design, patients enrolling into a residential addiction treatment center will be randomized to TAU (i.e., MAT, supportive group therapy) or TAU+MBRP with comparisons being made between MBRP (n=100) and treatment-as-usual (TAU; n=100) on assessment measures collected at baseline, prior to residential discharge, and at 1, 2, and 3-month follow-up time points. To address AIM 1 (TAU+MBRP, Adherence and Drug-Use): participants will be randomly assigned to receive TAU or MBRP+TAU, during their residence within an inpatient treatment setting and will complete assessments at enrollment, prior to discharge, and at 1, 2, and 3-months follow-up to assess MAT adherence and drug-use. Comparisons, on assessment measures collected at follow-up, will be made between treatment conditions to determine if MBRP+TAU results in greater number MAT adherence, fewer positive UDS, reduced drug-craving, and increased mindfulness. AIM 2 (MBRP Mechanisms of Change): Will determine whether the beneficial effects of MBRP on treatment outcome (i.e., MAT adherence, drug-use) are mediated by increases in mindfulness and distress tolerance. AIM 3 (Predictors of MAT Adherence): will examine the extent to which prior trauma-exposure and PTSD symptom severity moderates MAT adherence and drug-use outcomes, among TAU participants (but not MBRP participants), following discharge from residential treatment.

Eligibility criteria: Inclusion Criteria:

1. An informed consent document voluntarily signed and dated by the subject.
2. Subject must understand and be able to read and write in English.
3. Enrollment in residential treatment at study site.
4. Physically healthy males and females, aged 18 or older, who meet criteria for opioid use disorder (based on Diagnostic and Statistical Manual 5th Edition criteria) as their primary diagnosis, who are enrolled in residential treatment at the collaborating study site.
5. Subject must be willing to be randomized to treatment condition.
6. Subjects who are willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

1. Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder or organic mental disorder, including dementia-related psychosis as determined by the semi-structured interview.
2. Presence of any other psychiatric disorder that in the opinion of the PI will interfere with completion of the study or place the patient at heightened risk through participation in the study.

Primary outcomes:
measure: Adherence to Medication Assisted Treatment (MAT)
timeFrame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
measure: Adherence to Medication Assisted Treatment (MAT)
timeFrame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
measure: Adherence to Medication Assisted Treatment (MAT)
timeFrame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
measure: Drug Use (Urine Drug Screens)
timeFrame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
measure: Drug Use (Urine Drug Screens)
timeFrame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge)
measure: Drug Use (Urine Drug Screens)
timeFrame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge)
measure: Drug Use (self-report)
timeFrame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
measure: Drug Use (self-report)
timeFrame: Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
measure: Drug Use (self-report)
timeFrame: Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
measure: Opioid Craving
timeFrame: Assessed immediately prior to discharge from residential addiction treatment facility (approximately 50 days post-admission).
measure: Opioid Craving
timeFrame: Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge).
measure: Opioid Craving
timeFrame: Assessed 2 month following discharge from residential addiction treatment facility (approximately 60 days post-discharge).
measure: Opioid Craving
timeFrame: Assessed 3 month following discharge from residential addiction treatment facility (approximately 90 days post-discharge).
Secondary outcomes:
measure: Dispositional Mindfulness
timeFrame: Assessed at baseline, pre-discharge (approximately 50 days following residential admission), and 1-, 2-, and 3-months post-residential-treatment discharge.
measure: MBRP Treatment Adherence
timeFrame: Assessed for MBRP participants during residential treatment (~5 weeks)
measure: Reward Probability
timeFrame: Assessed at baseline, pre-discharge (approximately 50 days following residential admission), and 1-, 2-, and 3-months post-residential-treatment discharge.
measure: Post-Discharge Treatment Utilization
timeFrame: Assessed 1-, 2-, and 3-months post-residential-treatment discharge.
measure: Patient Reported Outcomes - Mental Health
timeFrame: Assessed at baseline, pre-discharge (approximately 50 days following residential admission), and 1-, 2-, and 3-months post-residential-treatment discharge.
Other outcomes:
Locations:
city: West Chester
country: United States
facility: Gaudenzia, Inc. (West Chester House)
state: Pennsylvania
Study officials:
affiliation: West Chester University of Pennsylvania
name: Michael J Gawrysiak, PhD
role: PRINCIPAL_INVESTIGATOR
References: