Screening, Evaluation and Assessment (SEA) Protocol at the NIDA IRP
NCT Number: NCT06552741
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Substance Use Disorder|Alcohol Use Disorder
Sponsor: National Institute on Drug Abuse (NIDA)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-10
Completion Date: 2047-01-01
Locations: National Institute on Drug Abuse, Baltimore, Maryland, 21224, United States

Summary:
Background:

People who will participate in research studies need to undergo proper screening, evaluation, and assessment (SEA). SEA helps keep those who participate in studies safe. It also helps ensure accurate study results. The National Institute on Drug Abuse (NIDA) Intramural Research Program (IRP) wants to screen people with alcohol and/or substance use disorders (ASUD) as well as people without ASUD for ongoing studies at NIDA in Baltimore, MD

Objective:

To screen people with or without ASUD for ongoing studies at NIDA. The ultimate goals are to learn why some people (1) use drugs; (2) stop using drugs; (3) use drugs but do not get addicted; and (4) never use drugs snd to develop ASUD treatments.

Eligibility:

People aged 18 years and older. They may (1) currently use nicotine, alcohol, opioids, cocaine, or other drugs; (2) no longer use them; or (3) have never used them.

Design:

Participants will have 1 screening visit that could last up to 8 hours. The visit may be split over more than 1 day. The duration of the screening may vary for each individual based on which studies they are interested in and screened for. The tests they undergo may vary and may include the following:

* Physical exam.
* Blood, saliva, and urine tests.
* Breath samples that test for alcohol and carbon monoxide.
* Test of heart function.
* Smell test that measures sense of smell.
* Tests of memory, attention, and thinking.
* Mental health evaluation.
* Mock magnetic resonance imaging (MRI) scan.
* Questionnaires about alcohol and other drug use, mental health, medical history, and life in general.

Primary Outcome Measures: To provide an initial clinical and general evaluation of participants to assess eligibility for potential inclusion into other clinical research protocols at the NIDA IRP., To screen participants for clinical research protocols and reduce variability as well as the burden of providing the same samples and data more than once (i.e., in screening and then again in the research protocol); Eligibility for clinical research protocols can only be determined once screening requirements for a clinical research protocol(s) are completed., One or more visits
Secondary Outcome Measures: To use data collected for the Primary Objective to develop and execute hypotheses-driven and hypotheses-generating analyses. To create a registry of participants that may be interested in and eligible to enroll/re-enroll in NIDA clinical ..., To generate data that may be used in future analyses (to be reviewed and approved as appropriate prior to commencing) in order to again maximize the utility of data and specimens while minimizing risk to subjects since no new procedures will need to be performed., Use the data collected for the primary endpoint to conduct future research to further characterize and understand alcohol and drug use, addiction, abstinence, and other outcomes in people with and without SUD.