ClinicalTrials.gg
RecruitingNCT07637669Updated Nov 10, 2026

Olfactory Function and Model-Based Behavior in People Living With HIV and SUD

An observational study in HIV and Substance Use Disorder, sponsored by National Institute on Drug Abuse (NIDA). Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by National Institute on Drug Abuse (NIDA) · Observational

Updated Nov 10, 2026Now RecruitingStart date moved+2 moreGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Background:

Human immunodeficiency virus (HIV) infection can affect areas of the brain that control thinking ability. These same areas of the brain also control the sense of smell. HIV infection is common in people with substance use disorder (SUD). SUD also affects thinking ability. Researchers want to learn more about the connection between the sense of smell and decision-making ability in people with HIV, SUD, or both.

Objective:

To test the sense of smell in people with HIV and/or SUD and how they make choices based on odors.

Eligibility:

People aged 18 to 65 years with any of these: (1) HIV, (2) SUD, (3) both HIV and SUD, or (4) neither SUD nor HIV.

Design:

Participants will have 2 visits. Each visit will last 3 to 5 hours.

In visit 1, participants will have a blood draw and a saliva swab. They will answer questions about their health, sleep habits, food intake, and substance use. They will have smell tests:

They will smell scented sticks and answer questions about them. They will be blindfolded for some tests.

They will perform tasks on a computer. They will look at pictures and smell pleasant food odors, such as chocolate cake or pizza. Smells will be delivered using a nasal mask. Their sniffing and breathing will be measured. They may also be exposed to odor-free air. They will eat food that corresponds to one of the food odors they smelled.

In visit 2, participants will do a saliva swab and a different computer task that involves odors. They will also have tests of their attention and memory. Participants may opt to have an imaging scan of the brain.

Read the detailed description

Study Description:

Cognitive impairments persist in people living with Human Immunodeficiency Virus (HIV) despite anti-retroviral therapy (ART). However, these impairments remain under-characterized and it is not clear whether they include deficits in model-based control of behavior. HIV is common in people with substance use disorder (SUD) but the combined impact of HIV and SUD on cognition remains unclear. The olfactory system is uniquely vulnerable to neurodegeneration and overlaps with brain regions involved in decision making. This study will investigate olfactory function and model-based behavior in people living with HIV and SUD, and relate these measures to biomarkers of neurodegeneration.

Objectives:

The primary objective of this protocol is to compare olfactory function and performance on behavioral tasks assessing model-based behavior between people living with and without HIV, and between people with and without SUD.

Secondary objectives of this protocol are to compare blood-based and MRI-based biomarkers of neurodegeneration between people living with and without HIV, and between people with and without SUD.

Endpoints:

Primary:

  • Olfactory function (Sniffin Sticks Threshold, Discrimination, and Identification tests)
  • Behavior on tasks assessing model-based behavior (outcome devaluation and sensory preconditioning)

Secondary:

  • Blood-based biomarker of neurodegeneration (Neurofilament Light Chain [NfL])
  • MRI-based biomarker of neurodegeneration (Magnetic Resonance Imaging)
02

Conditions studied

  • HIV
  • Substance Use Disorder

Keywords

  • HIV
  • Substance Use Disorder
  • Olfaction
  • Decision Making
03

In context

Substance-Related Disorders

2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.

This study's planned enrollment of 120 is below the median of 251 across 299 observational studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

National Institute on Drug Abuse (NIDA) is the lead sponsor of 393 studies on the registry; 19 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 5, 2026. See what changed

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

local community sample: metropolitan Baltimore area

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

For all participants:

  1. Aged 18-65 years old. Justification: prevalence of olfactory impairments increases with age; after age 53, the prevalence is 24.5 percent, increasing to 62.5 percent in people ages 80-97.
  2. Ability of subject to understand and the willingness to sign a written document.

For participants in the + and SUD+ and HIV+ and SUD- groups:

1. HIV positive.

For participants in the HIV+ and SUD+ and HIV- \& SUD+ groups:

1. Current history (past 12 months) of Substance Use Disorder (SUD) or medical treatment for SUD, other than Alcohol Use Disorder (AUD), mild Cannabis Use Disorder (CUD), or Tobacco Use Disorder (TUD). Non-medical treatments for SUD will be evaluated on a case-by-case-basis by the MAI.

Exclusion criteria

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

For all participants:

  1. History of neurological illnesses or neurosurgery including but not limited to cerebrovascular accident, Parkinson disease, Alzheimer disease, Huntington disease, central nervous system (CNS) tumor, significant head trauma with sequelae, multiple sclerosis or other demyelinating diseases, epilepsy, movement disorders. The MAI will also retain discretion to exclude based on a history of a neurological illness or trauma that may compromise data integrity.
  2. History of current (past 3 months) symptomatic, more than mild psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia, or posttraumatic stress disorder, excluding SUD. This will be determined at the discretion of the MAI.
  3. Candidates who recently (12 hours prior to a study visit) used medications and/or substances that are psychoactive or otherwise affect alertness will have to pass a clinical assessment for intoxication on the day of the study visit. Based on participant preferences and MAI/PI judgment, participants who fail the clinical assessment for intoxication will either be withdrawn or rescheduled.
  4. History of anaphylaxis, e.g., due to severe asthma or food and nonfood allergies (e.g., latex, detergents, soap, etc.). The MAI will retain discretion to exclude a participant based on this criterion.
  5. Uncorrected impairments in visual acuity severe enough to affect task performance.
  6. Non-English speaking. Justification: The data integrity of some of the behavioral tasks used in this study would be compromised as they have only been validated in English.
  7. Pregnancy.
  8. Any other condition that in the judgment of the investigators is incompatible with participation.

For participants in the + and SUD- and HIV- and SUD- groups:

  1. History (past 5 years) of SUD, excluding tobacco use disorder (TUD).
  2. Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence.
  3. Daily alcohol or drug use (excluding caffeine and nicotine) for at least 4 continuous weeks in the past 12 months.

For participants in the HIV- and SUD+ and HIV- and SUD- groups:

1. HIV positive.

For participants in the HIV- \& SUD- group:

1. Unable to undergo MRI scanning due to certain metallic or magnetic devices or implants in the body, or claustrophobia.

For the Optional MRI Segment:

1. Unable to undergo MRI scanning due to certain metallic or magnetic devices or implants in the body, or claustrophobia.

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)

Groups and cohorts

  • HIV- & SUD-

    Individuals without HIV and without an SUD

  • HIV- & SUD+

    Individuals without HIV and with an SUD

  • HIV+ & SUD-

    Individuals with HIV and without an SUD

  • HIV+ & SUD+

    Individuals with HIV and with an SUD

06

What researchers measure

Primary outcomes

  1. Olfactory function

    Sniffin Sticks Threshold, Discrimination, and Identification tests

    Time frame: Visit 1

  2. Model-based decision making

    Model-based decision making as assessed in an outcome devaluation task (visit 1) and sensory preconditioning task (visit 2)

    Time frame: Visit 1 & 2

Secondary outcomes

  1. Neurofilament Light Chain

    Plasma levels of neurofilament light chain \[NfL\]

    Time frame: Visit 1

  2. MRI

    MRI-based biomarkers of neurodegeneration

    Time frame: Visit 2 (optional)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data will be de-identified, which may be shared with (a) open data repositories and (b) with collaborators with whom proper data sharing agreements are in place, after consultation with and approval from the NIDA Technology Development Coordinator. The code to those data will not be shared. @@@@@@

Time frame: De-identified data may be made available for sharing for at least 5 years after study completion.

Access criteria: De-identified data may be shared with (a) open data repositories and (b) with collaborators with whom proper data sharing agreements are in place, after consultation with and approval from the NIDA Technology Development Coordinator. Requests for data sharing will have to be addressed to the study PI in writing.

No publications or documents are linked to this record.

09

Timeline

32 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Nov 2026; primary completion for Jun 2031, 55 months later.

Start moved 32 times since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, last on Nov 10, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2026
First posted
Jun 10, 2026
StartEst.
Nov 15, 2026was Sep 2026
Primary completionEst.
Jun 27, 2031
CompletionEst.
Jun 27, 2031
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 8, 2026
Sites
National Institute on Drug Abuse is now Recruiting
Oct 8, 2026
Start date
Sep 29, 2026→Nov 15, 2026
moved 32 times, Sep 25, 2026 – Nov 10, 2026
Eligibility
Criteria revised in 4 updates
What changed on Sep 29, 2026
Inclusion criteria
  • RemovedStated willingness to comply with all study procedures and availability for the duration of the study
  • RemovedAgreement to adhere to Lifestyle Considerations throughout study duration.
  • Edited-1. HIV positive.
  • Edited-1. Substance Use Disorder (SUD) other than Alcohol Use Disorder (AUD) or Tobacco Use Disorder (TUD).
Exclusion criteria
  • EditedHistory of current (past 12 months) uncontrolled major DSM-5 psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia, or posttraumatic stress disorder, excluding SUD. This will be determined at the discretion of the MAI.
  • EditedUncorrected impairments in visual acuity severe enough to affect task performance.
  • EditedFor participants in the HIV- and SUSUD+ and HIV- and SUD- groups:
What changed on Oct 7, 2026
Inclusion criteria
  • Edited1. Current history (past 12 months) of Substance Use Disorder (SUD) or medical treatment for SUD, other than Alcohol Use Disorder (AUD) or Tobacco Use Disorder (TUD). Nonmedical treatments for SUD will be evaluated on a case-by-case basis by the MAI.
Exclusion criteria
  • EditedHistoryLifetime history of current (past 12 months) SUD, excluding tobacco use disorder (TUD).
  • Edited-1. HIV positive.
  • Edited-1. Unable to undergo MRI scanning due to certain metallic or magnetic devices or implants in the body, or claustrophobia.
What changed on Oct 8, 2026
Inclusion criteria
  • Edited1. Current history (past 12 months) of Substance Use Disorder (SUD) or medical treatment for SUD, other than Alcohol Use Disorder (AUD) or Tobacco Use Disorder (TUD). NonmedicalNon-medical treatments for SUD will be evaluated on a case-by-case basis by the MAI.
What changed on Nov 5, 2026
Inclusion criteria
  • Edited1. Current history (past 12 months) of Substance Use Disorder (SUD) or medical treatment for SUD, other than Alcohol Use Disorder (AUD), mild Cannabis Use Disorder (CUD), or Tobacco Use Disorder (TUD). Non-medical treatments for SUD will be evaluated on a case-by-case -basis by the MAI.
Exclusion criteria
  • EditedHistory of current (past 123 months) uncontrolled majorsymptomatic, more than mild DSM-5 psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia, or posttraumatic stress disorder, excluding SUD. This will be determined at the discretion of the MAI.
  • EditedLifetime historyHistory (past 5 years) of SUD, excluding tobacco use disorder (TUD).
  • AddedFor participants in the HIV- \& SUD- group:
  • Added1. Unable to undergo MRI scanning due to certain metallic or magnetic devices or implants in the body, or claustrophobia.
across 4 updates, Sep 29, 2026 – Nov 5, 2026
Show all 32 updates
  1. Nov 10, 2026
    Start date Nov 12, 2026→Nov 15, 2026
  2. Nov 9, 2026
    Start date Nov 11, 2026→Nov 12, 2026
    + 1 other change: verification date
  3. Nov 6, 2026
    Start date Nov 10, 2026→Nov 11, 2026
  4. Nov 5, 2026
    Start date Nov 9, 2026→Nov 10, 2026
    Eligibility 1 inclusion criterion edited; 2 exclusion criteria edited, 2 added
    What changed in the criteria
    Inclusion criteria
    • Edited1. Current history (past 12 months) of Substance Use Disorder (SUD) or medical treatment for SUD, other than Alcohol Use Disorder (AUD), mild Cannabis Use Disorder (CUD), or Tobacco Use Disorder (TUD). Non-medical treatments for SUD will be evaluated on a case-by-case -basis by the MAI.
    Exclusion criteria
    • EditedHistory of current (past 123 months) uncontrolled majorsymptomatic, more than mild DSM-5 psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia, or posttraumatic stress disorder, excluding SUD. This will be determined at the discretion of the MAI.
    • EditedLifetime historyHistory (past 5 years) of SUD, excluding tobacco use disorder (TUD).
    • AddedFor participants in the HIV- \& SUD- group:
    • Added1. Unable to undergo MRI scanning due to certain metallic or magnetic devices or implants in the body, or claustrophobia.
  5. Nov 4, 2026
    Start date Nov 8, 2026→Nov 9, 2026
  6. Nov 3, 2026
    Start date Nov 5, 2026→Nov 8, 2026
  7. Nov 2, 2026
    Start date Nov 4, 2026→Nov 5, 2026
  8. Oct 30, 2026
    Start date Nov 3, 2026→Nov 4, 2026
  9. Oct 29, 2026
    Start date Nov 2, 2026→Nov 3, 2026
    + 1 other change: verification date
  10. Oct 28, 2026
    Start date Nov 1, 2026→Nov 2, 2026
  11. Oct 27, 2026
    Start date Oct 29, 2026→Nov 1, 2026
  12. Oct 26, 2026
    Start date Oct 28, 2026→Oct 29, 2026
  13. Oct 23, 2026
    Start date Oct 27, 2026→Oct 28, 2026
  14. Oct 22, 2026
    Start date Oct 26, 2026→Oct 27, 2026
  15. Oct 21, 2026
    Start date Oct 25, 2026→Oct 26, 2026
  16. Oct 20, 2026
    Start date Oct 22, 2026→Oct 25, 2026
  17. Oct 19, 2026
    Start date Oct 21, 2026→Oct 22, 2026
  18. Oct 16, 2026
    Start date Oct 20, 2026→Oct 21, 2026
  19. Oct 15, 2026
    Start date Oct 19, 2026→Oct 20, 2026
  20. Oct 14, 2026
    Start date Oct 18, 2026→Oct 19, 2026
  21. Oct 13, 2026
    Start date Oct 14, 2026→Oct 18, 2026
  22. Oct 9, 2026
    Start date Oct 13, 2026→Oct 14, 2026
  23. Oct 8, 2026
    Not yet recruiting→Recruiting
    National Institute on Drug Abuse is now Recruiting
    Start date Oct 12, 2026→Oct 13, 2026
    Eligibility 1 inclusion criterion edited
    What changed in the criteria
    Inclusion criteria
    • Edited1. Current history (past 12 months) of Substance Use Disorder (SUD) or medical treatment for SUD, other than Alcohol Use Disorder (AUD) or Tobacco Use Disorder (TUD). NonmedicalNon-medical treatments for SUD will be evaluated on a case-by-case basis by the MAI.
    + 1 other change: verification date
  24. Oct 7, 2026
    Start date Oct 11, 2026→Oct 12, 2026
    Eligibility 1 inclusion criterion edited; 3 exclusion criteria edited
    What changed in the criteria
    Inclusion criteria
    • Edited1. Current history (past 12 months) of Substance Use Disorder (SUD) or medical treatment for SUD, other than Alcohol Use Disorder (AUD) or Tobacco Use Disorder (TUD). Nonmedical treatments for SUD will be evaluated on a case-by-case basis by the MAI.
    Exclusion criteria
    • EditedHistoryLifetime history of current (past 12 months) SUD, excluding tobacco use disorder (TUD).
    • Edited-1. HIV positive.
    • Edited-1. Unable to undergo MRI scanning due to certain metallic or magnetic devices or implants in the body, or claustrophobia.
  25. Oct 6, 2026
    Start date Oct 8, 2026→Oct 11, 2026
  26. Oct 5, 2026
    Start date Oct 7, 2026→Oct 8, 2026
  27. Oct 2, 2026
    Start date Oct 6, 2026→Oct 7, 2026
  28. Oct 1, 2026
    Start date Oct 5, 2026→Oct 6, 2026
  29. Sep 30, 2026
    Start date Oct 4, 2026→Oct 5, 2026
    + 1 other change: verification date
  30. Sep 29, 2026
    Start date Oct 1, 2026→Oct 4, 2026
    Eligibility 2 inclusion criteria edited, 2 removed; 3 exclusion criteria edited
    What changed in the criteria
    Inclusion criteria
    • RemovedStated willingness to comply with all study procedures and availability for the duration of the study
    • RemovedAgreement to adhere to Lifestyle Considerations throughout study duration.
    • Edited-1. HIV positive.
    • Edited-1. Substance Use Disorder (SUD) other than Alcohol Use Disorder (AUD) or Tobacco Use Disorder (TUD).
    Exclusion criteria
    • EditedHistory of current (past 12 months) uncontrolled major DSM-5 psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia, or posttraumatic stress disorder, excluding SUD. This will be determined at the discretion of the MAI.
    • EditedUncorrected impairments in visual acuity severe enough to affect task performance.
    • EditedFor participants in the HIV- and SUSUD+ and HIV- and SUD- groups:
    + 1 other change: description
  31. Sep 28, 2026
    Start date Sep 30, 2026→Oct 1, 2026
  32. Sep 25, 2026
    Start date Sep 29, 2026→Sep 30, 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07637669
Responsible party
Sponsor
First posted
Jun 10, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Jun 27, 2031 (estimated)
Completion
Jun 27, 2031 (estimated)
Last update
Nov 10, 2026

Study contacts

NIDA IRP Screening Team
Contact
researchstudies@nida.nih.gov
(800) 535-8254
Thorsten Kahnt, Ph.D.
Contact
thorsten.kahnt@nih.gov
(667) 312-5175
Thorsten Kahnt, Ph.D.
principal investigator · National Institute on Drug Abuse (NIDA)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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