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

919 Participants Needed

Trial Summary

What is the purpose of this trial?

The target population is students attending high schools in small rural towns in the 14 counties that partially or fully fall within the Cherokee Nation reservation. Following recruitment of 20 school-based clusters, clusters are allocated to either the intervention condition or delayed-intervention control condition using constrained randomization. Constrained randomization helps to ensure balanced cluster sizes as well as similar levels of risk between the intervention and control at baseline. Study participants include all 10th grade students enrolled in the participating study high schools and students will be followed into the first year after their expected graduation.

Research Team

Kelli Komro, PhD

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+