Trial Outcomes & Findings for Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska Native Communities (NCT NCT04958798)
NCT ID: NCT04958798
Last Updated: 2026-06-11
Results Overview
The primary outcome is comprised of de-identified EMR data comparing MOUD initiation pre-intervention to post-intervention time periods with offset terms for time and clinic size.
COMPLETED
NA
2059 participants
Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)
2026-06-11
Participant Flow
De-identified electronic medical record (EMR) data from N=4 sites was collected. There was no direct client recruitment needed for the primary and secondary analyses.
Staff participants (who completed anonymous cross-sectional surveys) were not enrolled into study arms.
Unit of analysis: Site
Participant milestones
| Measure |
Sequence 1
Sequence 1 sites (Sites 1 and 2) completed 6 months of standard care (pre-intervention) before receiving the 6-month program-level implementation intervention.
|
Sequence 2
Sequence 2 sites (Sites 3 and 4) completed 12 months of standard care before receiving the 6-month program-level implementation intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
724 2
|
1335 2
|
|
Overall Study
COMPLETED
|
724 2
|
1335 2
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Culturally Centering Medications for Opioid Use Disorder With American Indian and Alaska Native Communities
Baseline characteristics by cohort
| Measure |
Site 1
n=557 Participants
Site 1 was included in Sequence 1.
|
Site 2
n=167 Participants
Site 2 was included in Sequence 1.
|
Site 3
n=131 Participants
Site 3 was included in Sequence 2.
|
Site 4
n=1204 Participants
Site 4 was included in Sequence 2.
|
Total
n=2059 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.3 Years
STANDARD_DEVIATION 10.1 • n=20 Participants
|
33.4 Years
STANDARD_DEVIATION 8.7 • n=20 Participants
|
38.4 Years
STANDARD_DEVIATION 12.0 • n=40 Participants
|
38.2 Years
STANDARD_DEVIATION 12.8 • n=6 Participants
|
37.0 Years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
344 Participants
n=20 Participants
|
96 Participants
n=20 Participants
|
50 Participants
n=40 Participants
|
714 Participants
n=6 Participants
|
1204 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
213 Participants
n=20 Participants
|
71 Participants
n=20 Participants
|
81 Participants
n=40 Participants
|
490 Participants
n=6 Participants
|
855 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
46 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
27 Participants
n=6 Participants
|
74 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
371 Participants
n=20 Participants
|
167 Participants
n=20 Participants
|
112 Participants
n=40 Participants
|
1137 Participants
n=6 Participants
|
1787 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
140 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
40 Participants
n=6 Participants
|
198 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)Population: All eligible EMR records from 4 participating sites during specified time frame comprised of individuals with OUD diagnosis, aged 18 and over and that were identified as American Indian or Alaska Native. The total known analysis population is the same for each time point.
The primary outcome is comprised of de-identified EMR data comparing MOUD initiation pre-intervention to post-intervention time periods with offset terms for time and clinic size.
Outcome measures
| Measure |
Pre-Intervention
n=2059 Participants
6- (sequence 1 sites) or 12-month (sequence 2 sites) usual care period before intervention delivery.
|
Post-Intervention
n=2059 Participants
6-month period following intervention delivery.
|
|---|---|---|
|
Number of Consumers With OUD Initiated Onto MOUD
|
480 participants
|
421 participants
|
SECONDARY outcome
Timeframe: Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)Population: All eligible EMR records from 4 participating sites during specified time frame comprised of individuals with OUD diagnosis, aged 18 and over and identified as AI/AN. The total known analysis population is the same for each time point.
Retention is operationalized as the number of clients at each site during each period who had at least one visit for care in three or more months within that period using de-identified data from the EMR comparing pre-intervention to post-intervention time periods.
Outcome measures
| Measure |
Pre-Intervention
n=2059 Participants
6- (sequence 1 sites) or 12-month (sequence 2 sites) usual care period before intervention delivery.
|
Post-Intervention
n=2059 Participants
6-month period following intervention delivery.
|
|---|---|---|
|
Number of Consumers With OUD Retained in Care
|
945 participants
|
688 participants
|
SECONDARY outcome
Timeframe: Pre-intervention: 6 months (sequence 1), 12 months (sequence 2); Post-Intervention: 6 months (sequence 1 and 2)Population: All eligible EMR records from three participating sites during the specified timeframe comprised of individuals with OUD diagnosis, aged 18 and over and identified as AI/AN Site 2 was not included in the screening outcome analysis because it was an addiction specialty practice and all clients have a documented substance use disorder (i.e., no screening available). The total known analysis population is the same for each time point.
Screening was operationalized as the number of clients screened for OUD of the number of clients with documented OUD and a visit from the de-identified EMR comparing pre-intervention to post-intervention time periods.
Outcome measures
| Measure |
Pre-Intervention
n=2059 Participants
6- (sequence 1 sites) or 12-month (sequence 2 sites) usual care period before intervention delivery.
|
Post-Intervention
n=2059 Participants
6-month period following intervention delivery.
|
|---|---|---|
|
Number of Consumers Screened for OUD
|
529 Participant
|
550 Participant
|
Adverse Events
Site 1
Site 2
Site 3
Site 4
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kamilla Venner, PhD
Center on Alcohol, Substance use, & Addiction (CASAA), University of New Mexico (UNM)
Results disclosure agreements
- Principal investigator is a sponsor employee Data collected from this study are owned by the local participating Tribes and Indigenous organizations. Any publication or sharing of data must be approved by Tribal or Indigenous organization partners.
- Publication restrictions are in place
Restriction type: OTHER