Opioid Use Disorder Clinical Trial
Official title:
Effects of Remote Motivational Enhancement on Engagement in Buprenorphine Treatment
Verified date | March 2023 |
Source | Cambridge Health Alliance |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators will conduct a Randomized Controlled Trial (RCT) comparing the Remote Motivational Enhancement (RME) coaching sessions + MindWell screenings arm to an Information-only + MindWell screenings arm on early engagement in treatment support services, as measured by overall action plan initiation.
Status | Active, not recruiting |
Enrollment | 25 |
Est. completion date | March 30, 2023 |
Est. primary completion date | January 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 or older - Meets DSM-IV criteria for opioid dependence or DSM-V criteria for opioid use disorder - Current patient enrolled in Bicycle Health's buprenorphine treatment program - Ability to provide informed consent - Access to the internet and an electronic device to attend remote coaching sessions via videoconferencing and complete online assessments - Sufficient English fluency to understand study procedures and assessments - Completion of the CAT-MH screening modules, BAM, and PSS measures (through CHAMindWell and Bicycle Health's service implementation project) Exclusion Criteria: - Non-English speaking - Reporting active homicidal or suicidal ideation - Exhibits signs of active mania or psychosis - Expected incarceration in next 12 weeks (those that are incarcerated during the study will be withdrawn from the study) - Prisoners - Unable or unwilling to use a mobile device - Has a medical contraindication to BUP - Unable to complete screening and baseline assessments - Unstable medical illness that could lead to an expected hospitalization in the next 12 weeks - Third-trimester pregnancy (if a pregnant participant plans to deliver within 12 weeks of study consent) |
Country | Name | City | State |
---|---|---|---|
United States | Cambridge Health Alliance | Cambridge | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Cambridge Health Alliance | Centers for Disease Control and Prevention, University of South Florida |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Action Plan Initiation: Social Service Engagement | To examine the effects of RME sessions vs. information alone on early engagement in types of treatment support services as measured by initiation in the social service subtype of treatment engagement. Initiation and engagement of support services for issues related to social determinants of health as measured by action plan initiation self-report at 4 weeks and/or reported appointment with social service professionals within 12 weeks. |
12 weeks | |
Other | Action Plan Initiation: Mental Health Engagement | To examine the effects of RME sessions vs. information alone on early engagement in types of treatment support services as measured by initiation in the mental health subtype of treatment engagement. Self-reported initiation and engagement with mental health services for psychiatric symptoms as measured by action plan initiation self-report at 4 weeks and reported appointment with mental health professionals within 12 weeks. |
12 weeks | |
Other | Action Plan Initiation: Wellness/Stress Reduction Engagement | To examine the effects of RME sessions vs. information alone on early engagement in types of treatment support services as measured by initiation in the wellness/stress reduction subtype of treatment engagement. Self-reported initiation of mental wellness/stress reduction services by action plan initiation self-report at 4 weeks and reported appointment with mental health professionals within 12 weeks. |
12 weeks | |
Other | Changes in Substance Use Risk | To examine a change in CAT-MH-SUD risk scores from 0 to 12 weeks. CAT-MH-SUD is computerized adaptive testing with a normalized score ranging from 0-100 (lower scores are better outcome). | 12 weeks | |
Other | Changes in Social Vulnerability | To examine a change in CAT-MH-SDOH scores from 0 to 12 weeks. CAT-MH-SDOH is computerized adaptive testing with a normalized score ranging from 0-100 (higher scores are better outcome). | 12 weeks | |
Other | Changes in Anxiety | To examine a change in CAT-MH-Anxiety scores from 0 to 12 weeks. CAT-MH-Anxiety is computerized adaptive testing with a normalized score ranging from 0-100 (lower scores are better outcome). | 12 weeks | |
Other | Changes in Depression | To examine a change in CAT-MH-Depression scores from 0 to 12 weeks. CAT-MH-Depression is computerized adaptive testing with a normalized score ranging from 0-100 (lower scores are better outcome). | 12 weeks | |
Other | Changes in Psychosis | To examine a change in CAT-MH-Psychosis scores from 0 to 12 weeks. CAT-MH-Psychosis is computerized adaptive testing with a normalized score ranging from 0-100 (lower scores are better outcome). | 12 weeks | |
Other | Changes in PTSD symptoms | To examine a change in CAT-MH-PTSD scores from 0 to 12 weeks. CAT-MH-PTSD is computerized adaptive testing with a normalized score ranging from 0-100 (lower scores are better outcome). | 12 weeks | |
Other | Changes in Mania/Hypomania | To examine a change in CAT-MH-Mania/Hypomania scores from 0 to 12 weeks. CAT-MH-M/HM is computerized adaptive testing with a normalized score ranging from 0-100 (lower scores are better outcome). | 12 weeks | |
Other | Changes in ADHD symptoms | To examine a change in CAT-MH-ADHD scores from 0 to 12 weeks. CAT-MH-ADHD is computerized adaptive testing with a normalized score ranging from 0-100 (lower scores are better outcome). | 12 weeks | |
Other | Changes in Level of Intrinsic Motivation | To examine between-group differences in APA-10 scores at weeks 4 and 12 (Higher levels represent increased intrinsic motivation). (Assessing self-efficacy and self-actualization as indicators of intrinsic motivation in accordance with the self-determination theory.) | 4 and 12 weeks | |
Other | Changes in Treatment Services Needed and Received | To examine between-group differences in the change in Treatment Services Needed and Received scores from baseline to week 12 (Each item represents a service that participants indicate needing and/or receiving over the past two weeks. The measure includes separate scales for assessing the need and receipt of medical services (6 items), alcohol / drug services (16 items), psychological / emotional services (18 items), psychiatric crisis services (8 items), and other services (22 items). The amount of unmet service needs is calculated by subtracting the number of services received in each area from the number needed in that respective area.) | 12 weeks | |
Primary | Engagement through Action Plan Initiation | 1. To examine the effects of RME sessions versus information alone on early engagement in treatment support services as measured by the Action Plan Initiation Survey (APIS-5) with a score of 5-7 representing action plan initiation. | 4 weeks | |
Secondary | Number of Self-Reported and Clinic-Reported Opioid Overdose | To examine the effect of RME versus information alone on the number of self-reported (with and without naloxone administered) and clinic-reported opioid overdoses throughout the 12 weeks of the study. | 12 weeks | |
Secondary | B/N Treatment Retention | To examine the effect of RME versus information alone on retention in buprenorphine OUD treatment with an active prescription at 24 weeks as assessed by an active prescription with Bicycle Health in the past 30 days. | 24 weeks | |
Secondary | Brief Addiction Monitor Scale | To examine the effect of RME versus information alone on change in Brief Addiction Monitor (BAM) subscale scores from 0 to 12 weeks. Drug Use (lower is better outcome) Risk Factors (lower is better outcome) (>12 is considered high risk) Protective Factors (higher is better outcome) (<12 is considered high risk) |
12 weeks |
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