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N/A

Prevention Program for Opioid Addiction

N/A
Waitlist Available
Led By Kelli Komro, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tenth grade students enrolled in the participating high schools
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (fall of 10th grade) up to spring of 12th grade
Awards & highlights

Study Summary

This trial will test a prevention program for Native American students in rural high schools. The program will be delivered during the 10th grade and followed up with participants during their first year after graduation.

Who is the study for?
This trial is for 10th grade students in small rural towns within the Cherokee Nation reservation, with town populations of 3,000 or less and class sizes between 30 to 100. Students who can't understand English or are from larger urban areas, as well as those in towns with existing drug prevention coalitions, cannot participate.Check my eligibility
What is being tested?
The study tests two programs: Connect Program and Communities Mobilizing for Change and Action (CMCA), aimed at opioid use disorder prevention. Schools are randomly chosen to either start the program now or later on, ensuring a fair comparison between groups.See study design
What are the potential side effects?
Since this trial involves community-based interventions rather than medical treatments, traditional side effects associated with medications are not applicable. However, there may be social or psychological impacts due to participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a 10th grader at a participating school.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (fall of 10th grade) up to spring of 12th grade
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (fall of 10th grade) up to spring of 12th grade for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Number of Days of Alcohol Use
Change in Number of Days of Heavy Alcohol Use
Change in Number of Days of Marijuana Use
+1 more
Secondary outcome measures
Change in Normative Estimates of Peer Drug Use
Pharmaceutical Preparations
Change in Self-Efficacy
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Preventive InterventionExperimental Treatment2 Interventions
Students in schools assigned to the preventive intervention study condition will take part in the Connect school-based prevention program and the community-level Communities Mobilizing for Change and Action (CMCA) intervention.
Group II: Delayed Intervention Control GroupActive Control1 Intervention
Students in schools assigned to the control group will not receive the Connect and CMCA interventions. Schools in the control group will receive usual school and community prevention and be offered the trial's programs after this three-year study ends.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,627 Previous Clinical Trials
2,559,765 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,447 Previous Clinical Trials
2,593,066 Total Patients Enrolled
5 Trials studying Opioid Addiction
648 Patients Enrolled for Opioid Addiction
Kelli Komro, PhDPrincipal InvestigatorEmory University

Media Library

Communities Mobilizing for Change and Action (CMCA) (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT04839978 — N/A
Opioid Addiction Research Study Groups: Delayed Intervention Control Group, Preventive Intervention
Opioid Addiction Clinical Trial 2023: Communities Mobilizing for Change and Action (CMCA) Highlights & Side Effects. Trial Name: NCT04839978 — N/A
Communities Mobilizing for Change and Action (CMCA) (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04839978 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the purpose of this research endeavor?

"The primary outcome tracked in this study, evaluated from Baseline to 6 Months Post-Graduation, is the Alteration of Days with Alcohol Consumption. Secondary metrics measured encompass Mutations in Estimated Peer Drug Use (e.g., alcohol, marijuana and prescription opioid misuse) where responses range from 0 = none or almost none to 4 = almost all or all; Modifications in Social Support assessed using 24 items answered on a 4 point scale ranging from 0 = never to 3 = often; and Variations in Self-Efficacy determined by four questions regarding requesting help or declining alcohol/drugs which are rated on a 0 -3 scale"

Answered by AI

Is the trial recruiting participants at this time?

"It appears that, per clinicaltrials.gov, this specific medical trial is no longer actively enrolling patients - the study was initially posted on September 29th 2021 and last updated on January 11th 2022. However, 291 other research projects are recruiting participants at this moment in time."

Answered by AI

Is it possible to become part of this experiment?

"This clinical trial seeks 1000 adolescents between 15 and 17 years of age who are battling opioid abuse. To qualify, applicants must be currently enrolled in the 10th grade at one of the participating high schools."

Answered by AI

Is the age threshold for this medical study limited to those over 60?

"According to the trial's eligibility criteria, potential participants must be aged between 15 and 17. Of note, there are 22 clinical trials open for those under 18 years old and 240 available for people over 65."

Answered by AI
~118 spots leftby Aug 2024