N/A
Completed N=919
Community Trial in the Cherokee Nation
Opioid Abuse
Source: ClinicalTrials.gov NCT04839978 ↗
Enrolled (actual)
919
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Number of Days of Alcohol Use — 0.71; 0.58; 0.70; 0.70 days
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days of Alcohol Use |
0.71; 0.58; 0.70; 0.70; 0.69; 0.84 | — |
| PRIMARY Number of Days of Heavy Alcohol Use |
0.51; 0.30; 0.50; 0.40; 0.48; 0.52 | — |
| PRIMARY Number of Days of Marijuana Use |
1.53; 1.71; 1.50; 1.88; 1.46; 2.07 | — |
| PRIMARY Number of Days of Opioid Misuse |
0.24; 0.07; 0.19; 0.10; 0.15; 0.13 | — |
| SECONDARY Social Support From Parent/Caregiver |
3.50; 3.45; 3.50; 3.47; 3.49; 3.48 | — |
| SECONDARY Social Support From Friend |
3.43; 3.39; 3.43; 3.40; 3.44; 3.41 | — |
| SECONDARY Social Support From Teacher |
3.25; 3.19; 3.27; 3.22; 3.29; 3.25 | — |
| SECONDARY Social Support From Other Adult |
3.05; 3.06; 3.09; 3.09; 3.14; 3.11 | — |
| SECONDARY Perceived Availability of Alcohol |
2.18; 2.22; 2.20; 2.27; 2.22; 2.32 | — |
| SECONDARY Perceived Availability of Marijuana |
2.04; 2.10; 2.06; 2.14; 2.08; 2.18 | — |
| SECONDARY Perceived Availability of Prescription Opioids |
1.52; 1.47; 1.51; 1.49; 1.49; 1.51 | — |
| SECONDARY Social Normative Beliefs About Alcohol Use |
2.11; 2.03; 2.10; 2.02; 2.10; 2.01 | — |
| SECONDARY Social Normative Beliefs About Marijuana |
2.16; 2.08; 2.16; 2.09; 2.16; 2.09 | — |
| SECONDARY Social Normative Beliefs About Prescription Opioids |
2.54; 2.46; 2.55; 2.49; 2.56; 2.51 | — |
| SECONDARY Self-Efficacy |
1.59; 1.65; 1.58; 1.64; 1.57; 1.63 | — |
| SECONDARY Normative Estimates of Peer Drug Use |
2.50; 2.51; 2.45; 2.52; 2.41; 2.52 | — |
| SECONDARY Proportion of Participants With Alcohol Use 6 Months Post-Graduation |
0.30; 0.47 | — |
| SECONDARY Proportion of Participants With Heavy Alcohol Use 6 Months Post-Graduation |
0.15; 0.25 | — |
| SECONDARY Proportion of Participants With Marijuana Use 6 Months Post-Graduation |
0.12; 0.20 | — |
| SECONDARY Number of Participants With Opioid Drug Misuse 6 Months Post-Graduation |
1; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Tenth grade students enrolled in the participating high schools
Exclusion Criteria
- unable to understand written or verbal English
Inclusion criteria for high schools:
- Counties that partially or fully fall within the Cherokee Nation reservation
- Town population of 3,000 or less
- Class size between 30 to 100 students
Exclusion criteria for high schools:
- Metropolitan and micropolitan cores (Rural-Urban Commuting Area codes of 1 and 4)
- Existence of a community drug prevention coalition
Data sourced from ClinicalTrials.gov (NCT04839978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.