Opioid-use Disorder
Conditions
Keywords
Addiction, Relapse Prevention, Opioid, Mindfulness
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. This study aims to include 200 patients diagnosed with with opioid use disorder (OUD), that are enrolled in a \ 60-day residential addiction treatment program. Participant recruitment will prioritize participants that are 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), and will be monitored following residential discharge to assess MAT adherence and drug-use relapse. Participants 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.
Interventions
BEHAVIORALMindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)
Integrates evidenced-based practices to decrease the probability and severity of relapse for those in addiction recovery. MBRP incorporates components from CBT relapse prevention and includes training in meditation practices as a means to foster increased awareness of emotional and cognitive experiences. MBRP also includes training in brief informal meditations aimed at increasing awareness and adaptive response to drug cues and negative affect.
BEHAVIORALTreatment-As-Usual
Standard treatment programming procedures for all individuals residing within the residential treatment program. Includes: supportive group therapy; Narcotics Anonymous/12-Step Programming; music, art, and animal therapy; psycho-education on general issues related to mental health and SUDs; and medication counseling.
Sponsors
West Chester University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessor collecting information from the participants during each post-discharge follow-up phase will be blind to which treatment condition the participant was assigned to.
Intervention model description
Participants will be randomly assigned to 1 of 2 conditions: MBRP+TAU or TAU.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Medication Assisted Treatment (MAT) | Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge). | Whether participant received MAT during post-residential-treatment discharge follow-up phase |
| Opioid Drug Use | Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge). | Participant relapse to opioids - Determined by synthesis of data recorded from participant EHR, participant self-report, and/or correspondence with participant healthcare provider. Any discrepancies between data sources (i.e., participant report no use, provider and/or EHR designated Yes to use) were coded as opioid use. |
| Opioid Craving | Assessed immediately prior to discharge from residential addiction treatment facility. | Opioid Craving Scale (OCS; McHugh et al., 2014), 3-item self-report questionnaire assessing opioid craving (higher scores = greater opioid craving; Range: 0-30). This scale uses a visual analogue scale ranging from 0 to 10 to assess opioid craving via response to three questions querying current craving (0 = not at all, 10 = extremely), past week desire for opioids when reminded of opiates (0 = no desire, 10 = extremely strong desire), and imagined likelihood of opioid use if in the environment in which opioids were previously used (0 = not at all, 10 = certainty of use). Total score reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dispositional Mindfulness | Assessed immediately prior to discharge from residential addiction treatment facility. | Cognitive and Affective Mindfulness Scale-Revised (CAMS-R; Feldman et al., 2007): 10-item self-report measure of central mindfulness aspects (i.e., present-centered attention, awareness, nonjudgmental acceptance) using language that does not reference meditation (higher scores = better, greater mindfulness; Range: 0-40). Total score reported. |
| Global Mental Health | Assessed immediately prior to discharge from residential addiction treatment facility. | Patient Reported Outcome Measurement Information System - Global Mental Health (PROMIS-GMH; Hays et al., 2009), 4-item self-report measure of general mental health based on a brief assessment of quality of life, mental health, satisfaction with social activities, and emotional problems (higher scores = better, greater mental health; Range: 4-20). Total score reported. |
| Reward Probability Inventory: Reward Probability | Assessed immediately prior to discharge from residential addiction treatment facility. | Reward Probability Index Reward Probability (RPI; Carvalho et al., 2011), 11-item self-report measure of pleasure/reinforcement derived from engaging in rewarding activities using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater reward probability; Range: 11-44). Total score reported. |
| Reward Probability Inventory: Environmental Suppression | Assessed immediately prior to discharge from residential addiction treatment facility. | Reward Probability Index Environmental Suppression (RPI; Carvalho et al., 2011), 9-item self-report measure of the perception that one has of the availability of rewarding activities in one's life using a 4-point scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher scores = better, greater perceived access to environmentally rewarding activities; Range: 9-36. Total score reported. |
| Abstinence Self-Efficacy | Assessed immediately prior to discharge from residential addiction treatment facility. | Abstinence self-efficacy. Drug Taking Confidence Questionnaire (DTCQ; Sklar et al., 1999), 8-item self-report measure of abstinence self-efficacy (higher scores = better, greater confidence in abstinence self-efficacy; Range: .00 - 1.00). Scores calculated by averaged responses across 8 items. |
| Posttraumatic Stress Severity | Assessed immediately prior to discharge from residential addiction treatment facility. | Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Weathers, Litz, et al., 2013), 20-item self-report measure of PTSD symptom severity. Higher scores = worse, more posttraumatic stress symptom severity; Range: 0-80. Total score reported. |
| Trauma Symptoms of Discrimination | Assessed immediately prior to discharge from residential addiction treatment facility. | Trauma Symptoms of Discrimination Scale (TSDS; Williams, Printz, et al., 2018), 21-item self-report measure of dysfunctional anxiety and avoidance due to fears of discrimination. Higher scores = worse, greater distress related to discrimination; Range: 21-84. Total score reported. |
| Treatment Engagement | Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge). | Post-Discharge (follow-up) treatment engagement. A 3-item self-report questionnaire recorded engagement in individual therapy, group therapy, and/or alcoholics/narcotics anonymous support groups following residential discharge (i.e., follow-up). Scores range from 0 (no engagement in any services) to 3 (engagement in all three services) over the past month. Higher scores reflect greater engagement in mental health services following discharge. |
| Mindfulness of Craving | Assessed immediately prior to discharge from residential addiction treatment facility. | Mindfulness of Craving Scale (Questionnaire in development). 10-item self-report measure of the awareness and nonjudgmental acceptance one has towards drug-craving states. Higher scores = better, greater mindfulness of craving; Range: 0-40. Total score reported. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael J Gawrysiak, PhD
West Chester University of Pennsylvania
Participant flow
Recruitment details
Recruitment of prospective participants occurred in the context of a residential addiction treatment facility located in the Mid-Atlantic region of the U.S. Prospective participants were notified of the study through a combination of study flyers posted in common spaces in the residential facility and through staff informing prospective participants of study enrollment, pending eligibility screening. Recruitment occurred between 8/1/21 to 8/20/24.
Pre-assignment details
One hundred eighty-seven participants were partially or fully evaluated to determine eligibility for study participation of which 82 were designated as ineligible: 48 excluded due to ineligibility, 6 excluded at the discretion of the study PI (i.e., adversarial behavior and/or noncompliance during eligibility assessment), 28 were excluded by virtue of being discharged prematurely from the residential facility, thereby failing to complete eligibility screening.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 38.65 Years STANDARD_DEVIATION 9.19 |
| Cognitive and Affective Mindfulness Scale - Revised (CAMS-R; Dispositional Mindfulness) | 24.43 Summed Score of Questionnaire Items STANDARD_DEVIATION 6.17 |
| Drug Taking Confidence Questionnaire (DTCQ; Abstinence Self-Efficacy) | .48 scores on a scale STANDARD_DEVIATION 0.27 |
| Medication Assisted Treatment (MAT) Prescribed to Participant No MAT | 6 Participants |
| Medication Assisted Treatment (MAT) Prescribed to Participant Sublocade/Buprenorphine | 6 Participants |
| Medication Assisted Treatment (MAT) Prescribed to Participant Suboxone | 30 Participants |
| Medication Assisted Treatment (MAT) Prescribed to Participant Vivitrol/Naltrexone | 3 Participants |
| Mindfulness of Craving Scale (MCS) | 19.47 Summed Score of Questionnaire Items STANDARD_DEVIATION 8.3 |
| Opioid Craving Scale (OCS) | 16.21 Summed Score of Questionnaire STANDARD_DEVIATION 8.96 |
| Patient Reported Outcome Measurement Information System - Global Mental Health (PROMIS-GMH) | 10.92 Summed Score of Questionnaire Items STANDARD_DEVIATION 3.08 |
| Perceived Ethnic Discrimination Questionnaire (PEDQ) | 2.39 Summed Score of Questionnaire Items STANDARD_DEVIATION 0.77 |
| Posttraumatic Stress Checklist for DSM-5 (Posttraumatic Stress Severity) | 39.34 Summed Score of Questionnaire Items STANDARD_DEVIATION 18.47 |
| Psychiatric Diagnosis Agoraphobia | 2 Participants |
| Psychiatric Diagnosis Alcohol Use Disorder | 13 Participants |
| Psychiatric Diagnosis Bi-Polar I Disorder | 14 Participants |
| Psychiatric Diagnosis Bi-Polar II Disorder | 0 Participants |
| Psychiatric Diagnosis Bulimia or Binge Eating Disorder | 1 Participants |
| Psychiatric Diagnosis Cannabis Use Disorder | 31 Participants |
| Psychiatric Diagnosis Cocaine Use Disorder | 33 Participants |
| Psychiatric Diagnosis Depressive Disorder | 42 Participants |
| Psychiatric Diagnosis Generalized Anxiety Disorder | 12 Participants |
| Psychiatric Diagnosis Obsessive Compulsive Disorder | 1 Participants |
| Psychiatric Diagnosis Panic Disorder | 11 Participants |
| Psychiatric Diagnosis Posttraumatic Stress Disorder | 60 Participants |
| Psychiatric Diagnosis Social Anxiety Disorder | 8 Participants |
| Psychiatric Diagnosis Stimulant Use Disorder (other than cocaine) | 39 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Reward Probability Inventory - Environmental Suppression | 18.88 Summed Score of Questionnaire Items STANDARD_DEVIATION 4.97 |
| Reward Probability Inventory - Reward Probability | 32.27 Summed Score of Questionnaire Items STANDARD_DEVIATION 5.34 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 42 Participants |
| Trauma Symptoms of Discrimination Scale (TSDS) | 47.38 Summed Score of Questionnaire Items STANDARD_DEVIATION 20.65 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 52 |
| other Total, other adverse events | 0 / 53 | 0 / 52 |
| serious Total, serious adverse events | 1 / 53 | 3 / 52 |
Outcome results
None listed