Opioid-use Disorder Clinical Trial
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)
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | August 30, 2024 |
Est. primary completion date | July 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Gaudenzia, Inc. (West Chester House) | West Chester | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
West Chester University of Pennsylvania | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence to Medication Assisted Treatment (MAT) | Whether participant receives MAT during post-residential-treatment discharge follow-up phase | Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge). | |
Primary | Adherence to Medication Assisted Treatment (MAT) | Whether participant receives MAT during post-residential-treatment discharge follow-up phase | Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge). | |
Primary | Adherence to Medication Assisted Treatment (MAT) | Whether participant receives MAT during post-residential-treatment discharge follow-up phase | Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge). | |
Primary | Drug Use (Urine Drug Screens) | Assessed via medical record review of urine drug-screens (when possible) | Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge). | |
Primary | Drug Use (Urine Drug Screens) | Assessed via medical record review of urine drug-screens (when possible) | Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge) | |
Primary | Drug Use (Urine Drug Screens) | Assessed via medical record review of urine drug-screens (when possible) | Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge) | |
Primary | Drug Use (self-report) | Assessed via participant completion of research-assistant administered time-line followback interview (follow-up phone call) | Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge). | |
Primary | Drug Use (self-report) | Assessed via participant completion of research-assistant administered time-line followback interview (follow-up phone call) | Assessed 2 months following discharge from residential addiction treatment facility (approximately 60 days post-discharge). | |
Primary | Drug Use (self-report) | Assessed via participant completion of research-assistant administered time-line followback interview (follow-up phone call) | Assessed 3 months following discharge from residential addiction treatment facility (approximately 90 days post-discharge). | |
Primary | Opioid Craving | Opioid craving will be assessed using the Opioid Craving Scale (McHugh et al., 2014). Scores for this scale range from 0 to 30, with higher scores reflecting greater craving for opioids (i.e., worse outcome). | Assessed immediately prior to discharge from residential addiction treatment facility (approximately 50 days post-admission). | |
Primary | Opioid Craving | Opioid craving will be assessed using the Opioid Craving Scale (McHugh et al., 2014). Scores for this scale range from 0 to 30, with higher scores reflecting greater craving for opioids (i.e., worse outcome). | Assessed 1 month following discharge from residential addiction treatment facility (approximately 30 days post-discharge). | |
Primary | Opioid Craving | Opioid craving will be assessed using the Opioid Craving Scale (McHugh et al., 2014). Scores for this scale range from 0 to 30, with higher scores reflecting greater craving for opioids (i.e., worse outcome). | Assessed 2 month following discharge from residential addiction treatment facility (approximately 60 days post-discharge). | |
Primary | Opioid Craving | Opioid craving will be assessed using the Opioid Craving Scale (McHugh et al., 2014). Scores for this scale range from 0 to 30, with higher scores reflecting greater craving for opioids (i.e., worse outcome). | Assessed 3 month following discharge from residential addiction treatment facility (approximately 90 days post-discharge). | |
Secondary | Dispositional Mindfulness | Cognitive and Affective Mindfulness Scale (Feldman et al., 2007). Scores for this scale range from 10 to 40 with higher scores reflecting greater dispositional mindfulness (i.e., favorable outcomes). Scores for this measure will determine the changes across time (i.e., pre-post treatment and follow-up phases of study). | Assessed at baseline, pre-discharge (approximately 50 days following residential admission), and 1-, 2-, and 3-months post-residential-treatment discharge. | |
Secondary | MBRP Treatment Adherence | Number of MBRP sessions attended and self-report measures recording homework completion (e.g., frequency/duration of meditation practices). | Assessed for MBRP participants during residential treatment (~5 weeks) | |
Secondary | Reward Probability | Reward Probability Inventory (Carvalho et al., 2011). Scores for this scale range from 20 to 80 with higher scores reflecting greater perceived access to and engagement in rewarding and pleasurable activities (i.e., favorable outcomes). Scores for this measure will determine the changes across time (i.e., pre-post treatment and follow-up phases of study). | Assessed at baseline, pre-discharge (approximately 50 days following residential admission), and 1-, 2-, and 3-months post-residential-treatment discharge. | |
Secondary | Post-Discharge Treatment Utilization | Assessment of behavioral treatment services used during post-discharge follow-up assessment time-points. | Assessed 1-, 2-, and 3-months post-residential-treatment discharge. | |
Secondary | Patient Reported Outcomes - Mental Health | Assessed with the Patient-Reported Outcomes Measurement Information. System (Cella et al., 2010). Scores for this scale range from 4 to 20 with higher scores reflecting greater overall mental health (i.e., favorable outcomes). Scores for this measure will determine the changes across time (i.e., pre-post treatment and follow-up phases of study). | Assessed at baseline, pre-discharge (approximately 50 days following residential admission), and 1-, 2-, and 3-months post-residential-treatment discharge. |
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