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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001868-DA

Sponsoring Institute

National Institute on Drug Abuse (NIDA)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 99 Years

Referral Letter Required

No

Population Exclusion(s)

Non-English Speaking;
Adults who are or may become unable to consent;
Children;
Fetuses;
Neonates

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Substance Use Disorder;
Alcohol Use Disorder

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute on Drug Abuse

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.

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Eligibility

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).


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Citations:

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; PMCID: PMC8828806.

Bilgin R, T(SqrRoot) kel 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.

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.

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.

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.

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.

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.

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.

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. PMID: 26026014.

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.

HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. PMID: 14399272; PMCID: PMC495331.

Wolfensberger M, Schnieper I, Welge-L(SqrRoot) ssen A. Sniffin'Sticks: a new olfactory test battery. Acta Otolaryngol. 2000 Mar;120(2):303-6. doi: 10.1080/000164800750001134. PMID: 11603794.

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.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Lorenzo Leggio, M.D.
National Institute on Drug Abuse (NIDA)
NIH BIOMEDICAL RESEARCH CENTER BG RM 04A515
251 BAYVIEW BLVD.
BALTIMORE MD 21224
(240) 478-1503
lorenzo.leggio@nih.gov

Lorenzo Leggio, M.D.
National Institute on Drug Abuse (NIDA)
NIH BIOMEDICAL RESEARCH CENTER BG RM 04A515
251 BAYVIEW BLVD.
BALTIMORE MD 21224
(240) 478-1503
lorenzo.leggio@nih.gov

Lorenzo Leggio, M.D.
NIH BIOMEDICAL RESEARCH CENTER BG RM 04A515
251 BAYVIEW BLVD.
BALTIMORE MD 21224
(443) 740-2801
lorenzo.leggio@nih.gov

Clinical Trials Number:

NCT06552741

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