Screening, Evaluation and Assessment (SEA) Protocol at the NIDA IRP
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorNational Institute on Drug Abuse (NIDA)
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-99 years old.
Proficient ability to read, write, and understand English.
Stated willingness to comply with all screening procedures and availability for the duration of the screening period
Ability of subject to understand and the willingness to sign a written informed consent document.
Disqualifiers
None
Trial population
10,000 people with and without substance use disorders (SUDs), aged 18-99
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
10,000 Participants
are grouped into 2 trial groupsGroup A: Control
Group B: Patient
Trial outcomes
Primary outcomes
1
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.
Time frame
One or more visitsSecondary outcomes
1
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.
Time frame
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov