Prevention Program for Opioid Addiction

Overseen By Terrence Kominsky, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to prevent opioid addiction among high school students in small rural towns within the Cherokee Nation reservation. Researchers are testing two programs: the Connect school-based prevention program and the Communities Mobilizing for Change and Action (CMCA) community program. Some schools will implement these programs immediately, while others will start after the study concludes. Tenth graders attending participating high schools in these areas, who understand English, are suitable candidates for this trial. As an unphased trial, this study offers students the chance to participate in a pioneering effort to combat opioid addiction in their communities.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these programs are safe for students?

Research has shown that community programs like Communities Mobilizing for Change and Action (CMCA) are generally well-received. These programs involve the community to tackle substance misuse, and several studies have demonstrated positive results without major safety issues. For example, one study found that community involvement in applying proven methods helped reduce opioid overdoses, indicating these approaches are safe.

The Connect Program, also part of this trial, has been studied for its success in lowering substance use. Research demonstrated that educational activities in schools led to significant drops in alcohol and drug use among students. These results suggest the program is well-received, with no major negative effects reported.

Both programs aim to prevent opioid misuse through education and community participation. The evidence so far indicates they are safe for participants, with no significant risks found in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Prevention Program for Opioid Addiction because it uses a proactive, community-centered approach to tackle addiction before it starts. Unlike standard treatments that focus on individual rehabilitation, this program combines the Connect school-based prevention strategy with the Communities Mobilizing for Change and Action (CMCA) intervention to engage entire communities and schools in prevention efforts. This dual approach aims to create supportive environments that discourage opioid use, making it a unique and promising alternative to traditional methods that often intervene only after addiction has developed.

What evidence suggests that the Connect and CMCA programs are effective for preventing opioid addiction?

In this trial, participants in the preventive intervention arm will engage in both the Communities Mobilizing for Change and Action (CMCA) program and the Connect Program. Research has shown that the CMCA program helps reduce opioid use. In a past study, community groups using proven strategies significantly lowered opioid overdose deaths. Another study found CMCA effective in changing behavior among older underage drinkers, suggesting it can also influence young people's choices about opioids.

The Connect Program focuses on support from social networks, which has improved treatment results for opioid use disorder. Studies have shown that educational activities in the program increase knowledge and improve attitudes about opioid use, leading to better understanding and prevention. Together, these programs aim to prevent opioid addiction among students by changing attitudes and behaviors through efforts in the community and schools. ^{2 3 4 5 6}

Who Is on the Research Team?

Kelli Komro, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a 10th grader at a participating school.

Class size between 30 to 100 students

Town population of 3,000 or less

Exclusion Criteria

I cannot understand written or spoken English.

There is a group of people working together to prevent drug use in the community.

Metropolitan and micropolitan cores (Rural-Urban Commuting Area codes of 1 and 4)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Students participate in the Connect school-based prevention program and the community-level CMCA intervention

3 years

Follow-up

Participants are monitored for drug misuse and social support outcomes

6 months post-graduation

What Are the Treatments Tested in This Trial?

Interventions

• Communities Mobilizing for Change and Action (CMCA)
• Connect Program

Trial Overview 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.

How Is the Trial Designed?

Group I: Preventive Intervention Experimental Treatment 2 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: Control Group Active Control 1 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 will be offered the trial's programs after the end of this three-year study.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8058324/

Using community engagement to implement evidence ... The HEALing Communities Study (HCS) utilizes CE research to support the strategic selection, implementation and adoption of EBPs to reduce opioid overdose ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2401177

Community-Based Cluster-Randomized Trial to Reduce ... In this 12-month multimodal intervention trial involving community coalitions in the deployment of evidence-based practices to reduce opioid overdose deaths,

3. sciencedirect.com sciencedirect.com/science/article/pii/S0376871620304919

Community engagement to implement evidence-based ... The Healing Communities Study seeks to show how community engagement can support the adoption of EBPs for addressing the opioid crisis.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5847450/

Communities Mobilizing for Change on Alcohol (CMCA) The CMCA intervention was previously tested in a 15-community randomized trial; results indicated significant effects on older underage drinkers (age 18–20), ...

5. cadca.org cadca.org/wp-content/uploads/2023/05/practical_theorist_10_-_addressing_the_opioid_crisis.pdf

Addressing the Opioid Crisis through Community Prevention These coalitions achieved positive outcomes by implementing a comprehensive and complementary set of strategies framed by the Seven. Strategies for Community ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK424850/

PREVENTION PROGRAMS AND POLICIES - NCBI - NIH Community-based prevention programs can be effective in helping to address major challenges raised by substance misuse and its consequences. Such programs are ...