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

NCT06552741 | Recruiting

• 2 other identifiers: 10001868001868-DA
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder; Substance Use Disorder

Keywords

Alcohol; Drug; Smoking; Substance; Opioid; Nicotine; Cocaine; CONTROL; Vaping

Outcome Measures

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.

  One or more visits

Secondary 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 ...

  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 Arms (2)

Control

Subjects without substance use disorders

Patient

Patient with substance use disorders

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

RECRUITING

Related Publications (13)

• Choi S, Rosenbloom D, Stein MD, Raifman J, Clark JA. Differential Gateways, Facilitators, and Barriers to Substance Use Disorder Treatment for Pregnant Women and Mothers: A Scoping Systematic Review. J Addict Med. 2022 May-Jun 01;16(3):e185-e196. doi: 10.1097/ADM.0000000000000909.

  PMID: 34380985 BACKGROUND

• Bilgin R, Tukel SS. Effects of glucose on the activity of erythrocyte membrane Ca2+ATPase in subjects with normal and impaired glucose tolerance. Biochem Mol Biol Int. 1996 Jun;39(3):547-52. doi: 10.1080/15216549600201601.

  PMID: 8828806 BACKGROUND

• Robinson SM, Sobell LC, Sobell MB, Leo GI. Reliability of the Timeline Followback for cocaine, cannabis, and cigarette use. Psychol Addict Behav. 2014 Mar;28(1):154-62. doi: 10.1037/a0030992. Epub 2012 Dec 31.

  PMID: 23276315 BACKGROUND

• Sobell LC, Brown J, Leo GI, Sobell MB. The reliability of the Alcohol Timeline Followback when administered by telephone and by computer. Drug Alcohol Depend. 1996 Sep;42(1):49-54. doi: 10.1016/0376-8716(96)01263-x.

  PMID: 8889403 BACKGROUND

• Vinson DC, Reidinger C, Wilcosky T. Factors affecting the validity of a Timeline Follow-Back interview. J Stud Alcohol. 2003 Sep;64(5):733-40. doi: 10.15288/jsa.2003.64.733.

  PMID: 14572197 BACKGROUND

• Wesson DR, Ling W. The Clinical Opiate Withdrawal Scale (COWS). J Psychoactive Drugs. 2003 Apr-Jun;35(2):253-9. doi: 10.1080/02791072.2003.10400007.

  PMID: 12924748 BACKGROUND

• Gossop M. The development of a Short Opiate Withdrawal Scale (SOWS). Addict Behav. 1990;15(5):487-90. doi: 10.1016/0306-4603(90)90036-w.

  PMID: 2248123 BACKGROUND

• Bohn MJ, Babor TF, Kranzler HR. The Alcohol Use Disorders Identification Test (AUDIT): validation of a screening instrument for use in medical settings. J Stud Alcohol. 1995 Jul;56(4):423-32. doi: 10.15288/jsa.1995.56.423.

  PMID: 7674678 BACKGROUND

• Russell J, Richardson N, Dar A. Use of a modified Clinical Institute Withdrawal Assessment (CIWA) for symptom-triggered management of alcohol withdrawal syndrome. Clin Med (Lond). 2015 Jun;15 Suppl 3:s20. doi: 10.7861/clinmedicine.15-3-s20. Epub 2015 May 29. No abstract available.

  PMID: 26026014 BACKGROUND

• Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x.

  PMID: 2597811 BACKGROUND

• HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.

  PMID: 14399272 BACKGROUND

• Wolfensberger M, Schnieper I, Welge-Lussen A. Sniffin'Sticks: a new olfactory test battery. Acta Otolaryngol. 2000 Mar;120(2):303-6. doi: 10.1080/000164800750001134.

  PMID: 11603794 BACKGROUND

• Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.

  PMID: 12765673 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders; Alcoholism; Smoking; Vaping

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders; Behavior

Study Officials

• Lorenzo Leggio, M.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shannon M Pfistner

CONTACT

(800) 535-8254; pfistners@nida.nih.gov

Lorenzo Leggio, M.D.

CONTACT

(240) 478-1503; lorenzo.leggio@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 14, 2024
• Study Start: September 4, 2024
• Primary Completion (Estimated): January 1, 2045
• Study Completion (Estimated): January 1, 2047
• Last Updated: April 8, 2026

Record last verified: 2026-02-02

Locations

US (1)