Screening, Evaluation and Assessment (SEA) Protocol at the NIDA IRP

June 2, 2026 updated by: National Institute on Drug Abuse (NIDA)

Screening, Evaluation, and Assessment (SEA) Protocol at the NIDA IRP

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.

Study Overview

Status

Recruiting

Conditions

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

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

10,000 people with and without substance use disorders (SUDs), aged 18-99

Description

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
Subjects without substance use disorders
Patient
Patient with substance use disorders

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: One or more visits
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

Outcome Measure
Measure Description
Time Frame
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 ...
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Lorenzo Leggio, M.D., National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2024

Primary Completion (Estimated)

January 1, 2045

Study Completion (Estimated)

January 1, 2047

Study Registration Dates

First Submitted

August 7, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10001868
  • 001868-DA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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