Opioid AbuseNCT04839978
Community Trial in the Cherokee Nation
A study testing Connect Program and Communities Mobilizing for Change and Action (CMCA) in people with Opioid Abuse, run by Emory University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 17 years
- Conditions the study is for
- Opioid Abuse
- What is being tested?
- Connect Program and Communities Mobilizing for Change and Action (CMCA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 919 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Tenth grade students enrolled in the participating 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
Who cannot join
- unable to understand written or verbal English
- Metropolitan and micropolitan cores (Rural-Urban Commuting Area codes of 1 and 4)
- Existence of a community drug prevention coalition
Trial locations and contacts
1 site in 1 country.
United States1 site
Cherokee Nation Reservation
Tahlequah, Oklahoma, 74464
About this study
Official title: Community Randomized Trial in the Cherokee Nation: Connect and CMCA for Preventing Drug Misuse Among Older Adolescents
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.
Read the detailed description
The national public health opioid crisis has disproportionately burdened rural White populations, and disproportionately burdened American Indian populations. Therefore, the Cherokee Nation (CN) and Emory University public health scientists have designed an opioid prevention trial to be conducted in at-risk rural communities in the CN (in northeast Oklahoma) with primarily White and American Indian adolescents and young adults. The goal of this study is to implement and evaluate a theory-based, integrated multi-level community intervention designed to prevent the onset and escalation of opioid and other drug misuse. The researchers propose a cluster randomized trial building directly on the success of their most recent previous trial, which demonstrated that the intervention effectively reduced alcohol and other drug use among American Indian and other youth living within the CN. Two distinct intervention approaches-community organizing as implemented in the established Communities Mobilizing for Change and Action (CMCA) intervention protocol, and universal school-based brief intervention and referral as implemented in the established Connect intervention protocol -will be expanded and integrated to further enhance effects in preventing and reducing opioid misuse. The CMCA and Connect interventions were originally designed to target adolescent alcohol use but nevertheless showed significant beneficial effects on use of other drugs, including prescription drug misuse. The proposed study will: (1) further improve the design of the interventions with increased focus on opioids, (2) test the expanded, integrated versions in a cluster randomized trial, and (3) design and test new systems for sustained implementation within existing structures of the Cherokee Nation. Building upon the extant prevention science evidence, this study will respond to a gap in evidence concerning opioid misuse prevention among at-risk adolescents transitioning to young adulthood among American Indian and other rural youth.
- Conditions
- Opioid Abuse
- Being tested
- Connect Program, Communities Mobilizing for Change and Action (CMCA)
- Keywords
- American Indian, Cherokee Nation, Community intervention
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connect ProgramBehavioural
The Connect program includes school-based screening, brief intervention and referral, and will be treated as part of the participating schools' prevention programs. A computer-based screening and brief intervention will be supported by Cherokee Nation Behavioral Health (CNBH) supervised Connect coaches universally, to reduce potential stigma associated with speaking to a Connect coach and to reinforce drug free norms among all students. Follow-up of moderate to high-risk youth will be conducted by a Connect Coach through Zoom, other electronic communication, or in-person visits, with referral to Cherokee Nation or community services if deemed necessary.
Communities Mobilizing for Change and Action (CMCA)Behavioural
The community-level intervention Communities Mobilizing for Change and Action (CMCA) will involve educating and organizing of adult volunteers and consent will be assumed by their participation. Trainings and tools will be provided, including Family Action Kits, to support local families, community organizations and citizens, including information on national and local opioid and other drug use, evidence-based policies, programs and practices, and how to motivate and create family and local action for drug prevention.
| Study group | Role | What they receive |
|---|---|---|
| Preventive Intervention | Experimental | 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. Receives: Behavioral: Connect Program; Behavioral: Communities Mobilizing for Change and Action (CMCA) |
| Control Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days of Alcohol Use
The number of days of alcohol use in the past 30 days is compared between study arms.
Measured: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Number of Days of Heavy Alcohol Use
The number of days of heavy alcohol use in the past 30 days is compared between study arms. Heavy alcohol use is defined as having at least four (among young women) or five (among young men) alcoholic drinks within a couple of hours.
Measured: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Number of Days of Marijuana Use
The number of days of marijuana use in the past 30 days is compared between study arms.
Measured: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Number of Days of Opioid Misuse
The number of days of opioid drug misuse use in the past 30 days is compared between study arms.
Measured: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Secondary outcomes (16)
Social Support From Parent/Caregiver
Social support from parents/caregivers is assessed with 6 items which are responded to on a 4-point scale where 1 = never and 4 = often. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater support.
Measured: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Support From Friend
Social support from a friend is assessed with 6 items, which are responded to on a 4-point scale where 1 = never and 4 = often. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater support.
Measured: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Support From Teacher
Social support from a teacher is assessed with 6 items, which are responded to on a 4-point scale where 1 = never and 4 = often. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater support.
Measured: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Support From Other Adult
Social support from an adult, other than a parent/caregiver or teacher, is assessed with 6 items which are responded to on a 4-point scale where 1 = never and 4 = often. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater support.
Measured: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Perceived Availability of Alcohol
Ease or difficulty in accessing alcohol is assessed with 4 items using a 4-point scale where 1 = very difficult to get and 4 = very easy to get. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater ease of availability.
Measured: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Perceived Availability of Marijuana
Ease or difficulty in accessing marijuana is assessed with 5 items using a 4-point scale where 1 = very difficult to get and 4 = very easy to get. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater ease of availability.
Measured: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Perceived Availability of Prescription Opioids
Ease or difficulty in accessing prescription opioids is assessed with 5 items using a 4-point scale where 1 = very difficult to get and 4 = very easy to get. The total score is expressed as the mean across items and ranges from 1 to 4, with higher scores indicating greater ease of availability.
Measured: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Normative Beliefs About Alcohol Use
Participants are asked 4 items to assess if they think various social groups (parents, community adults, peers, self) disapprove of young people drinking alcohol. Responses are given as 1 = don't disapprove, 2 = disapprove, and 3 = strongly disapprove. The total score is expressed as the mean across items and ranges from 1 to 3, with higher scores indicating stronger disapproval
Measured: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Normative Beliefs About Marijuana
Participants are asked 4 items to assess if they think various social groups (parents, community adults, peers, self) disapprove of young people using marijuana. Responses are given as 1 = don't disapprove, 2 = disapprove, and 3 = strongly disapprove. The total score is expressed as the mean across items and ranges from 1 to 3, with higher scores indicating stronger disapproval.
Measured: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Normative Beliefs About Prescription Opioids
Participants are asked 4 items to assess if they think various social groups (parents, community adults, peers, self) disapprove of young people missing prescription opioids. Responses are given as 1 = don't disapprove, 2 = disapprove, and 3 = strongly disapprove. The total score is expressed as the mean across items and ranges from 1 to 3, with higher scores indicating stronger disapproval.
Measured: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Self-Efficacy
Self-efficacy is assessed with 3 items asking how easy or hard it would be for participants to ask for help or refuse alcohol or drugs. Responses given on a 4-point scale, where 1 = very easy and 4 = very hard. The total score is expressed as the mean across items and ranges from 1 to 4, with lower scores indicating increased self-efficacy.
Measured: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Normative Estimates of Peer Drug Use
Normative estimates of peer drug use (alcohol, marijuana, prescription opioid misuse) are assessed with 3 items asking about how many of their peers in school used drugs in the past year. Possible responses are 1 = none or almost none, 2 = less than half, 3 = about half, 4 = more than half, and 5 = almost all or all. The total score is expressed as the mean across items and ranges from 1 to 5, with higher scores indicating higher normative estimates of peer drug use.
Measured: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Proportion of Participants With Alcohol Use 6 Months Post-Graduation
Model predicted proportion of participants with alcohol use in the past 30 days is compared between study arms. The Least Squares Mean values are limited to the 6-month post-graduation time point while adjusting for baseline use.
Measured: 6 Months Post-Graduation
Proportion of Participants With Heavy Alcohol Use 6 Months Post-Graduation
Model predicted proportion of participants with heavy alcohol use in the past 30 days is compared between study arms. Heavy alcohol use is defined as having at least four (among young women) or five (among young men) alcoholic drinks within a couple of hours. The Least Squares Mean values are limited to the 6-month post-graduation time point while adjusting for baseline use.
Measured: 6 Months Post-Graduation
Proportion of Participants With Marijuana Use 6 Months Post-Graduation
Model predicted proportion of participants with marijuana use in the past 30 days is compared between study arms. The Least Squares Mean values are limited to the 6-month post-graduation time point while adjusting for baseline use.
Measured: 6 Months Post-Graduation
Number of Participants With Opioid Drug Misuse 6 Months Post-Graduation
The number of participants reporting prescription opioid misuse in the past 30 days at the survey administered 6-month post-graduation.
Measured: 6 Months Post-Graduation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start29 Sep 2021
- Primary completion17 May 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Opioid AbuseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sixteen to 20 high schools and surrounding towns within the 14 counties that partially or fully fall within the Cherokee Nation reservation in northeast Oklahoma will be randomly assigned to receive the preventive interventions offered by this study or usual school and community prevention. A total of 800 to 1200 students are expected to enroll from the randomized sites.
- Masking
- None (open label)
- Enrolment
- 919 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Kelli Komro, Emory University
- Investigators
- Kelli Komro, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839978
- Sponsor's protocol ID
- STUDY00000404
- Other IDs
- UH3DA050234, UG3DA050234
- Status last verified
- Feb 2026
- First submitted
- 8 Apr 2021
- Last updated
- 5 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data will be available for sharing, provided all data requests are reviewed and approved by the Cherokee Nation Institutional Review Board (IRB). Data and associated documentation sharing requires a negotiated data-sharing agreement that provides for: 1) review and approval of the data request and study protocol by the Cherokee Nation IRB, 2) a commitment to using the data only for research purposes, 3) restrictions against attempting to identify study participants, 4) a commitment to securing the data using secure computer technology, 5) a commitment to destroying data after the specific requested analyses are completed, 6) agreement to submit all presentations and manuscripts to the appropriate tribal authorities for review and approval prior to public dissemination and publication, 7) reporting responsibilities to the Cherokee Nation, 8) restrictions on redistribution of the data to third parties, and 9) proper acknowledgement of the source of the data.
Publications
Komro KA, Livingston MD, Skinner JR, Livingston BJ, Kominsky TK, Jagtiani A, Barry CM, Wagenaar AC, Cooper HLF, Harmon M, Ivanich E, LaBounty H, Gassaway AN, Talavera-Brown SL. Primary Prevention of Drug Overdoses in Rural Low-Resource and Tribal Communities: A Cluster Randomized Trial. Am J Public Health. 2025 Sep;115(9):1508-1517. doi: 10.2105/AJPH.2025.308205.
PubMed 40768695Jagtiani A, Livingston MD, Barry CM, Talavera-Brown S, LaBounty H, Skinner JR, Livingston BJ, Lincoln AN, Komro KA. Tribal Identity, Pain Interference, and Substance Use Among American Indian and Alaska Native Adolescents. JAMA Pediatr. 2024 Nov 1;178(11):1192-1198. doi: 10.1001/jamapediatrics.2024.3284.
PubMed 39312248Komro KA, Kominsky TK, Skinner JR, Livingston MD, Livingston BJ, Avance K, Lincoln AN, Barry CM, Walker AL, Pettigrew DW, Merlo LJ, Cooper HLF, Wagenaar AC. Study protocol for a cluster randomized trial of a school, family, and community intervention for preventing drug misuse among older adolescents in the Cherokee Nation. Trials. 2022 Feb 23;23(1):175. doi: 10.1186/s13063-022-06096-0.
PubMed 35197100
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Randomized Trial in the Cherokee Nation: Connect and CMCA for Preventing Drug Misuse Among Older Adolescents
- ClinicalTrials.gov ID
- NCT04839978
- Acronym / sponsor ID
- STUDY00000404
- Conditions
- Opioid Abuse
- Keywords
- American Indian, Cherokee Nation, Community intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 919 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Posted 30 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The national public health opioid crisis has disproportionately burdened rural White populations, and disproportionately burdened American Indian populations. Therefore, the Cherokee Nation (CN) and Emory University public health scientists have designed an opioid prevention trial to be conducted in at-risk rural communities in the CN (in northeast Oklahoma) with primarily White and American Indian adolescents and young adults. The goal of this study is to implement and evaluate a theory-based, integrated multi-level community intervention designed to prevent the onset and escalation of opioid and other drug misuse. The researchers propose a cluster randomized trial building directly on the success of their most recent previous trial, which demonstrated that the intervention effectively reduced alcohol and other drug use among American Indian and other youth living within the CN. Two distinct intervention approaches-community organizing as implemented in the established Communities Mobilizing for Change and Action (CMCA) intervention protocol, and universal school-based brief intervention and referral as implemented in the established Connect intervention protocol -will be expanded and integrated to further enhance effects in preventing and reducing opioid misuse. The CMCA and Connect interventions were originally designed to target adolescent alcohol use but nevertheless showed significant beneficial effects on use of other drugs, including prescription drug misuse. The proposed study will: (1) further improve the design of the interventions with increased focus on opioids, (2) test the expanded, integrated versions in a cluster randomized trial, and (3) design and test new systems for sustained implementation within existing structures of the Cherokee Nation. Building upon the extant prevention science evidence, this study will respond to a gap in evidence concerning opioid misuse prevention among at-risk adolescents transitioning to young adulthood among American Indian and other rural youth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sixteen to 20 high schools and surrounding towns within the 14 counties that partially or fully fall within the Cherokee Nation reservation in northeast Oklahoma will be randomly assigned to receive the preventive interventions offered by this study or usual school and community prevention. A total of 800 to 1200 students are expected to enroll from the randomized sites.
| Arm | Type | Receives |
|---|---|---|
| Preventive Intervention | Experimental | Behavioral: Connect Program, Behavioral: Communities Mobilizing for Change and Action (CMCA)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. |
| Control Group | No 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 may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Tenth grade students enrolled in the participating 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
Key exclusion criteria (3 listed)
- unable to understand written or verbal English
- Metropolitan and micropolitan cores (Rural-Urban Commuting Area codes of 1 and 4)
- Existence of a community drug prevention coalition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Connect ProgramThe Connect program includes school-based screening, brief intervention and referral, and will be treated as part of the participating schools' prevention programs. A computer-based screening and brief intervention will be supported by Cherokee Nation Behavioral Health (CNBH) supervised Connect coaches universally, to reduce potential stigma associated with speaking to a Connect coach and to reinforce drug free norms among all students. Follow-up of moderate to high-risk youth will be conducted by a Connect Coach through Zoom, other electronic communication, or in-person visits, with referral to Cherokee Nation or community services if deemed necessary. | Behavioural | Preventive Intervention |
| Communities Mobilizing for Change and Action (CMCA)The community-level intervention Communities Mobilizing for Change and Action (CMCA) will involve educating and organizing of adult volunteers and consent will be assumed by their participation. Trainings and tools will be provided, including Family Action Kits, to support local families, community organizations and citizens, including information on national and local opioid and other drug use, evidence-based policies, programs and practices, and how to motivate and create family and local action for drug prevention. | Behavioural | Preventive Intervention |
Primary outcome
Number of Days of Alcohol Use
Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
The number of days of alcohol use in the past 30 days is compared between study arms.
Number of Days of Heavy Alcohol Use
Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
The number of days of heavy alcohol use in the past 30 days is compared between study arms. Heavy alcohol use is defined as having at least four (among young women) or five (among young men) alcoholic drinks within a couple of hours.
Number of Days of Marijuana Use
Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
The number of days of marijuana use in the past 30 days is compared between study arms.
Number of Days of Opioid Misuse
Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
The number of days of opioid drug misuse use in the past 30 days is compared between study arms.
16 secondary outcomes
Social Support From Parent/Caregiver
Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Support From Friend
Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Support From Teacher
Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Support From Other Adult
Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Perceived Availability of Alcohol
Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Perceived Availability of Marijuana
Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Perceived Availability of Prescription Opioids
Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Normative Beliefs About Alcohol Use
Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Normative Beliefs About Marijuana
Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Social Normative Beliefs About Prescription Opioids
Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Self-Efficacy
Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Normative Estimates of Peer Drug Use
Time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)
Proportion of Participants With Alcohol Use 6 Months Post-Graduation
Time frame: 6 Months Post-Graduation
Proportion of Participants With Heavy Alcohol Use 6 Months Post-Graduation
Time frame: 6 Months Post-Graduation
Proportion of Participants With Marijuana Use 6 Months Post-Graduation
Time frame: 6 Months Post-Graduation
Number of Participants With Opioid Drug Misuse 6 Months Post-Graduation
Time frame: 6 Months Post-Graduation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40768695Komro KA, Livingston MD, Skinner JR, Livingston BJ, Kominsky TK, Jagtiani A, Barry CM, Wagenaar AC, Cooper HLF, Harmon M, Ivanich E, LaBounty H, Gassaway AN, Talavera-Brown SL. Primary Prevention of Drug Overdoses in Rural Low-Resource and Tribal Communities: A Cluster Randomized Trial. Am J Public Health. 2025 Sep;115(9):1508-1517. doi: 10.2105/AJPH.2025.308205.
- Derived from this study: PubMed 39312248Jagtiani A, Livingston MD, Barry CM, Talavera-Brown S, LaBounty H, Skinner JR, Livingston BJ, Lincoln AN, Komro KA. Tribal Identity, Pain Interference, and Substance Use Among American Indian and Alaska Native Adolescents. JAMA Pediatr. 2024 Nov 1;178(11):1192-1198. doi: 10.1001/jamapediatrics.2024.3284.
- Derived from this study: PubMed 35197100Komro KA, Kominsky TK, Skinner JR, Livingston MD, Livingston BJ, Avance K, Lincoln AN, Barry CM, Walker AL, Pettigrew DW, Merlo LJ, Cooper HLF, Wagenaar AC. Study protocol for a cluster randomized trial of a school, family, and community intervention for preventing drug misuse among older adolescents in the Cherokee Nation. Trials. 2022 Feb 23;23(1):175. doi: 10.1186/s13063-022-06096-0.
- Individual participant dataSharing planned: Yes. Deidentified participant data will be available for sharing, provided all data requests are reviewed and approved by the Cherokee Nation Institutional Review Board (IRB). Data and associated documentation sharing requires a negotiated data-sharing agreement that provides for: 1) review and approval of the data request and study protocol by the Cherokee Nation IRB, 2) a commitment to using the data only for research purposes, 3) restrictions against attempting to identify study participants, 4) a commitment to securing the data using secure computer technology, 5) a commitment to destroying data after the specific requested analyses are completed, 6) agreement to submit all presentations and manuscripts to the appropriate tribal authorities for review and approval prior to public dissemination and publication, 7) reporting responsibilities to the Cherokee Nation, 8) restrictions on redistribution of the data to third parties, and 9) proper acknowledgement of the source of the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelli Komro, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connect Program and Communities Mobilizing for Change and Action (CMCA) in people with Opioid Abuse, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days of Alcohol Use (time frame: Surveys were administered each fall and spring semester from baseline (fall of 10th grade) to spring of 12th grade (up to 31 months and 19 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04839978, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.