Regulatory Issues 1. Reporting mechanisms of adverse events (AEs) and serious adverse events (SAEs) to Institutional Review Board (IRB) and National Institute on Drug Abuse (NIDA). The PI will report any SAE, whether or not related to study intervention to the UNM IRB, NIDA and the Zuni Tribal Council within 48 hours of the principal investigator's (PI's) notification of the SAE. Outcomes of SAEs will be reported to NIDA and the Zuni Tribal Council and UNM IRB as they become known. A summary of the SAEs that occurred during the previous year will be included in the annual progress report to NIDA, which will also be sent to the Zuni Tribal Council.