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Communities That HEAL Intervention for Opioid Use Disorder
N/A
Waitlist Available
Research Sponsored by RTI International
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 19-30
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a new intervention aimed at reducing opioid overdose deaths by 40% in 67 communities that are highly affected by addiction.
Who is the study for?
The HEALing Communities Study is for communities in Kentucky, Ohio, Massachusetts, or New York that are heavily impacted by opioid overdoses. Eligible communities must have a high rate of opioid-related deaths and be willing to implement strategies like medication-assisted treatment (MOUD), overdose training, and naloxone distribution.
What is being tested?
This study tests the 'Communities That HEAL' intervention aimed at reducing opioid overdose deaths by 40%. Some communities will start the program right away while others will wait to begin. The effectiveness of this community-wide approach on preventing deaths from opioids is being compared.
What are the potential side effects?
Since this trial involves community interventions rather than medications, there aren't traditional side effects. However, potential challenges could include resistance to change within communities or difficulties in coordinating across different sectors like healthcare and justice.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ months 19-30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 19-30
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of opioid overdose deaths
Secondary study objectives
Opioids
Buprenorphine
Naloxone
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Wave 2 - Wait-list comparisonExperimental Treatment1 Intervention
Communities in Wave 2 will continue usual care during the first 30 months of the trial. At month 31, Wave 2 communities will begin receiving the CTH intervention.
Group II: Wave 1 - InterventionExperimental Treatment1 Intervention
Communities in Wave 1 will receive the CTH intervention during the first 30 months of the trial. The intervention will include 3 components: community engagement to assist key stakeholders in applying evidence-based practices to addressing their opioid crisis, a menu of evidence-based practices for communities to select and implement, and a communications campaign to build demand for evidence-based practices to address overdose and opioid use disorder.
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Who is running the clinical trial?
Boston Medical CenterOTHER
401 Previous Clinical Trials
883,708 Total Patients Enrolled
Columbia UniversityOTHER
1,486 Previous Clinical Trials
2,655,264 Total Patients Enrolled
RTI InternationalLead Sponsor
196 Previous Clinical Trials
844,479 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My community is ready to implement drug treatment, overdose training, and naloxone distribution.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Wave 2 - Wait-list comparison
- Group 2: Wave 1 - Intervention
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