Clinical trial NCT06552741: Screening, Evaluation and Assessment (SEA) Protocol at the NIDA IRP
Official title: Screening, Evaluation, and Assessment (SEA) Protocol at the NIDA IRP
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Substance Use Disorder
Alcohol Use Disorder
Keywords: Alcohol
Drug
Smoking
Substance
Opioid
Nicotine
Cocaine
CONTROL
Vaping
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2024-08-14
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 10,000 people with and without substance use disorders (SUDs), aged 18-99

Brief 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.

Detailed description: Study Description:

This protocol describes the screening and evaluation process used by the National Institute on Drug Abuse (NIDA) Intramural Research Program (IRP) to assess eligibility of individuals interested in enrolling in other NIDA IRP clinical research protocols. This protocol and clinical research protocols conducted at the NIDA IRP seek to improve understanding about of the nature of alcohol and Substance Use Disorders (hereby referenced as SUD, inclusive of alcohol use disorder), determine the potential use of novel SUD therapies and establish the effects of SUD on the development, maturation, function, and structure of the body s organ systems.

Objectives:

Primary Objective:

-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.

Secondary Objectives:

* To use the data collected for the Primary Objective toward the development and execution of 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 IRP clinical research protocols.

Endpoints:

Primary Endpoint:

-Screening, evaluation, and assessment for eligibility to participate in other NIDA clinical research protocols.

Secondary Endpoints:

-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

Eligibility criteria: * INCLUSION CRITERIA:

This protocol is seeking individuals with current or past SUDs and/or AUD, as well as those who have never had an SUD or AUD. These individuals also may or may not be in treatment for their AUD/SUDs.

To be eligible to participate in this study, an individual must meet the following criteria:

* 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.

EXCLUSION CRITERIA:

Individuals who lack capacity to consent to research participation to this protocol as determined by the Evaluation to Sign Consent (ESC).

Primary outcomes:
measure: 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.
timeFrame: One or more visits
Secondary outcomes:
measure: 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 ...
timeFrame: 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.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: National Institute on Drug Abuse
state: Maryland
Study officials:
affiliation: National Institute on Drug Abuse (NIDA)
name: Lorenzo Leggio, M.D.
role: PRINCIPAL_INVESTIGATOR
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