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

NCT07637669 | Not Yet Recruiting

• 2 other identifiers: 10002591002591-DA
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV; Substance Use Disorder

Keywords

HIV; Substance Use Disorder; Olfaction; Decision Making

Outcome Measures

Primary Outcomes (2)

• Olfactory function

  Sniffin Sticks Threshold, Discrimination, and Identification tests

  Visit 1

• Model-based decision making

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

  Visit 1 & 2

Secondary Outcomes (2)

• Neurofilament Light Chain

  Visit 1

• MRI

  Visit 2 (optional)

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

local community sample: metropolitan Baltimore area

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• For all participants:
• Stated willingness to comply with all study procedures and availability for the duration of the study
• 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.
• Agreement to adhere to Lifestyle Considerations throughout study duration.
• 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:
• HIV positive.
• For participants in the HIV+ and SUD+ and HIV- \& SUD+ groups:
• Substance Use Disorder (SUD) other than Alcohol Use Disorder (AUD) or Tobacco Use Disorder (TUD).

You may not qualify if:

• 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.
• 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.
• 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.
• Pregnancy.
• 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:
• History of current (past 12 months) SUD, excluding tobacco use disorder.
• 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 SU+ and HIV- and SUD- groups:

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Anosmia

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thorsten Kahnt, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NIDA IRP Screening Team

CONTACT

(800) 535-8254; researchstudies@nida.nih.gov

Thorsten Kahnt, Ph.D.

CONTACT

(667) 312-5175; thorsten.kahnt@nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): June 17, 2026
• Primary Completion (Estimated): June 27, 2031
• Study Completion (Estimated): June 27, 2031
• Last Updated: June 12, 2026

Record last verified: 2026-06-03

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)