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

Официальное название

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

Обзор

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.

Подробное описание

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

Первичные конечные точки

• 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. [Срок оценки: One or more visits]

Вторичные конечные точки (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 ... [Срок оценки: 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.]

Критерии участия

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• National Institute on Drug Abuse — Baltimore

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT06552741 · 10001868 · 001868-DA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗