Substance Use DisorderNCT06552741
Screening, Evaluation and Assessment (SEA) Protocol at the NIDA IRP
An observational study of Substance Use Disorder and Alcohol Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorder, Alcohol Use Disorder
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to 1 Jan 2047
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10,000 people with and without substance use disorders (SUDs), aged 18-99
Who may be able to join
- 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.
Who cannot join
- Individuals who lack capacity to consent to research participation to this protocol as determined by the Evaluation to Sign Consent (ESC).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institute on Drug Abuse
Baltimore, Maryland, 21224
Lorenzo Leggio, M.D., 240-478-1503, lorenzo.leggio@nih.gov
Shannon Pfistner, (667) 312-5240, pfistners@nida.nih.gov
About this study
Official title: 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
Read more
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.
Read the 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
- Conditions
- Substance Use Disorder, Alcohol Use Disorder
- Keywords
- Alcohol, Drug, Smoking, Substance, Opioid, Nicotine, Cocaine, CONTROL, Vaping
- Medical subject headings
- Substance-Related Disorders, Alcoholism, Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Subjects without substance use disorders | |
| Patient | Patient with substance use disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 ...
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start4 Sep 2024
- Primary completion1 Jan 2045 (estimated)
- Study completion1 Jan 2047 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lorenzo Leggio, M.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552741
- Sponsor's protocol ID
- 10001868
- Other IDs
- 001868-DA
- Status last verified
- 19 Aug 2026
- First submitted
- 7 Aug 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34380985Bilgin 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.
PubMed 8828806Robinson 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.
PubMed 23276315Sobell 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.
PubMed 8889403Vinson 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.
PubMed 14572197Wesson 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.
PubMed 12924748Gossop 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.
PubMed 2248123Bohn 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.
PubMed 7674678Russell 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.
PubMed 26026014Sullivan 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.
PubMed 2597811HAMILTON 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.
PubMed 14399272Wolfensberger 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.
PubMed 11603794Kondrup 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.
PubMed 12765673
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening, Evaluation, and Assessment (SEA) Protocol at the NIDA IRP
- ClinicalTrials.gov ID
- NCT06552741
- Acronym / sponsor ID
- 10001868
- Conditions
- Substance Use Disorder, Alcohol Use Disorder
- Keywords
- Alcohol, Drug, Smoking, Substance, Opioid, Nicotine, Cocaine, CONTROL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 1 Jan 2045 (estimated)
- Study completion
- 1 Jan 2047 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Subjects without substance use disorders |
| Patient | – | –Patient with substance use disorders |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10,000 people with and without substance use disorders (SUDs), aged 18-99
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals who lack capacity to consent to research participation to this protocol as determined by the Evaluation to Sign Consent (ESC).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 34380985Choi 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.
- Background: PubMed 8828806Bilgin 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.
- Background: PubMed 23276315Robinson 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.
- Background: PubMed 8889403Sobell 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.
- Background: PubMed 14572197Vinson 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.
- Background: PubMed 12924748Wesson 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.
- Background: PubMed 2248123Gossop 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.
- Background: PubMed 7674678Bohn 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.
- Background: PubMed 26026014Russell 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.
- Background: PubMed 2597811Sullivan 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.
- Background: PubMed 14399272HAMILTON 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.
- Background: PubMed 11603794Wolfensberger 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.
- Individual participant dataSharing planned: Undecided
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Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorenzo Leggio, M.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorder and Alcohol Use Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shannon M Pfistner ((800) 535-8254, pfistners@nida.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: One or more visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06552741, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.