Clinical trial Recruiting at 1 site Observational Ages 18 to 65

Olfactory function and decision-making in people with HIV and/or substance use

Official title: Olfactory Function and Model-based Behavior in People Living With HIV and SUD

Run by National Institutes of Health Clinical Center (CC) · NCT07637669 · Data updated 2026-11-12

This study tests how the sense of smell relates to decision-making in adults with HIV, substance use, both, or neither.

Quick facts

Study typeObservational
Ages18 Years to 65 Years
SexAll
Enrollment120 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Locations1 site (Baltimore, Maryland)
StatusRecruiting
StartedNovember 15, 2026
Main results expectedJune 27, 2031
Study endsJune 27, 2031
Registry record updatedNovember 10, 2026
Trial IDNCT07637669 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–65 with HIV, SUD, both, or neither, who can consent and comply with study visits.

Probably not a fit

People who do not have HIV or SUD or those unable to complete the testing or MRI components may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will assess smell ability and decision-making in adults aged 18–65 across four groups (HIV only, SUD only, both, or neither). The study uses smell tests and behavioral tasks to measure how people make choices based on odors, along with blood tests and MRI biomarkers of neurodegeneration. Participants come in for two visits, each lasting 3–5 hours, including questionnaires, saliva and blood samples, and imaging or biomarker collection as available. The goal is to understand how HIV and SUD affect olfactory function and model-based behavior, and how these relate to neurodegenerative markers.

Why it matters

Potential benefit: If successful, findings could improve understanding of brain-odor links and inform future approaches to cognitive health in HIV and SUD populations.

How similar studies have gone: Past research has shown olfactory and cognitive changes in HIV and in SUD, but this combined approach is relatively novel and exploratory.

Who can join: the full rules

Show full inclusion / exclusion criteria
* 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 informed consent document.

For participants in the HIV+ 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:

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 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.
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 clinically significant 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 HIV+ 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.

Where it's running

  • National Institute on Drug Abuse
    Baltimore, Maryland, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.