NCT07637669 · National Institute on Drug Abuse (NIDA)
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
What this study is about
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.
View original scientific description
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.
Primary outcome measures
Olfactory function
Time frame: Visit 1
Sniffin Sticks Threshold, Discrimination, and Identification tests
Model-based decision making
Time frame: Visit 1 & 2
Model-based decision making as assessed in an outcome devaluation task (visit 1) and sensory preconditioning task (visit 2)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria: For all participants:
- 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.
- 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) 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:
- 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.
- History 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.
- 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.
- 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.
- Uncorrected impairments in visual acuity severe enough to affect task performance.
- 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.
- 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:
- Lifetime history of SUD, excluding tobacco use disorder (TUD).
- 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.
- 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 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
- Baltimore, Maryland
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 16, 2026 · Source of record for eligibility and locations