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Wpływ ostrego zatrucia alkoholem na procesy nerwowe podczas podejmowania decyzji o zaangażowaniu się w zachowania ryzykowne HIV

23 października 2026 zaktualizowane przez: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Wpływ ostrego zatrucia alkoholem na procesy nerwowe podczas podejmowania decyzji o zaangażowaniu się w ryzykowne zachowania związane z HIV

Background:

People who binge drink are more likely to have risky sexual encounters, and alcohol changes brain activity associated with reward decisions related to those behaviors. Researchers want to better understand how alcohol s effects on risky sexual behavior that might lead people to contract sexually transmitted diseases (STDs) like HIV, the virus that causes AIDS.

Objective:

To study how alcohol impacts decisions about engaging in risky sex.

Eligibility:

Healthy adults ages 21-65 without alcohol use disorder

Design:

Participants will have 2 study visits, 1 month apart. They will arrive and depart via taxi. They will consume alcohol at 1 visit, chosen at random.

At visit 1, participants will answer questions about HIV knowledge, HIV risk behaviors, and sexual interests. They will view pictures of clothed people and pick those they might have sex with. They will think about the person s risk of having an STD and whether they would use a condom during sex.

At both visits, participants will sit in a bar-like room and have 2 drinks that may contain alcohol. Then they will have magnetic resonance imaging (MRI) brain scans. For this, they will lie on a table that slides in and out of a metal tube. The scanner makes loud noises; they will get earplugs. They will complete tasks that include looking at pictures and making choices about money.

At the beginning of both visits the participants will be screened with urine drug test and pregnancy test. Duiring each visit the participants breath alcohol will be measured, and they will discuss whether they feel intoxicated.

Participants will get snacks and stay at the clinic for up to 6 hours after the MRIs.

...

Przegląd badań

Status

Zakończony

Szczegółowy opis

Study Description:

Participants will complete baseline measures of sexual history and preferences, HIV risk and knowledge, and tasks designed to measure delay discounting of protected sex. At the first of two visits, subjects will then receive either alcohol or placebo beverages to increase their blood alcohol concentration to approximately 0.08g/dl. Then, participants will undergo functional magnetic resonance imaging while completing two protected sex discounting tasks, with and without emotional content. At a second visit, participants will receive the opposite type of beverage (alcohol or placebo). Participants will be randomly assigned to order of beverages.

Objectives:

The purpose of this protocol is to identify the neural substrates by which acute alcohol intoxication leads to an increase in HIV risk behavior during sexual encounters. An additional aim is to characterize the influence of negative and positive social context on the neural mechanism by which acute alcohol intoxication leads to an increase in HIV risk behavior during sexual encounters. This study uses a two-visit alcohol-administration procedure to examine alcohol-induced changes in brain activity during decisions about risky sex.

Endpoints:

Brain Engagement during Protected Sex Discounting (MRI-Scan Portion)

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

20

Faza

  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Maryland
      • Bethesda, Maryland, Stany Zjednoczone, 20892
        • National Institutes of Health Clinical Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

21 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

  • INCLUSION CRITERIA:
  • 21 to 65 years old.

EXCLUSION CRITERIA for Alcohol Administration/MR scanning:

  • Having less than one binge drinking episode (episodes operationally defined as having consumed four or more drinks on one day if female/ five or more if male) based on the most recent measurement within the past 90 days of screening as determined by Alcohol Timeline Follow-back.
  • Currently seeking treatment for alcohol use disorder
  • Significant history of head trauma or cranial surgery
  • History of neurological disease based on self-report or neuromotor physical exam, conducted by a health care provider, that would interfere with neuroimaging research.
  • Have fulfilled DSM-5 criteria for a current substance use disorder other than alcohol use disorder
  • History of primary psychotic disorder
  • Have liver function tests (AST, ALT, GGT, ALP) 3-times the upper limit of normal (ULN); or have Total Bilirubin above 1.5 ULN and Albumin below 3.5 g/dl;
  • HIV positive
  • Currently taking PrEP
  • Female participants only (or other individuals able to get pregnant): Currently pregnant or breastfeeding
  • Any flag on the MRI Safety Screening Questionnaire, unless cleared by medically responsible staff (MD/NP)
  • Reported to have a facial, body, and limb flushing response to the consumption of alcohol, as determined by the Alcohol Flushing Questionnaire
  • Unable to understand and communicate in English at a level sufficient to complete questionnaires and tasks that are not validated in any language other than English.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: arm one

participants receive alcohol beverage

High-proof alcohol (e.g., Everclear) will be mixed with orange juice in an approximately 1:3 ratio and split evenly into two drinks. After splitting the orange juice into two cups, a small amount (approx. 6 ml) of high-proof alcohol will be floated on top of the beverage.

Komparator placebo: arm two

Placebo

The final drink will have the same volume of liquid as the alcohol beverage.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Protected Sex Discounting MRI-Scan Portion
Ramy czasowe: First Task

Participants will see a picture of one of the individuals selected during the pre-scan PSD procedure. They will also see two choices corresponding to 1) "Sex with this person without a condom NOW" or 2) "Sex with this person with a condom [NOW or delay] . Participants will have 6 seconds to press a button corresponding to their choice. Conditions of interest will vary as follows: choice difficulty- easy (probability of choosing later option <0.33 or >0.67) or hard (probability of choosing alternative option between 0.33 and 0.67); preference- now (probability of choosing later option <0.5) or delay (probability of choosing later option >0.5); sexual risk - high (individual most likely to have an STD) or low (individual least likely to have an STD); and desirability - high (individual you most want to have sex with) or low (individual you least want to have sex with).

First Task

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Sexual Sensation Seeking Scale
Ramy czasowe: Sixth Task

This will be used to assess interest in risky sexual activity. It is an 11 question self-report questionnaire with each question scored on a scale of 1-4. Scores on this measure will allow us to consider whether individual differences in the reward value of sexual activity account for differences in performance and neural correlates of the PSD task.

Sixth Task
Sexual Desire Inventory
Ramy czasowe: Fourth Task

This will be used to assess interest in sexual activity. It is a 14-question self-report questionnaire with each question scored on a scale of 0-8, where higher scores reflect more sexual desire. It typically takes less than 10 minutes to complete. Scores on this measure will allow us to consider whether individual differences in the reward value of sexual activity account for differences in performance and neural correlates of the PSD task.

Fourth Task
Risk MRI Task
Ramy czasowe: Eighth Task

During scanning, participants will be shown two squares: a "safe" square and a "risk" square. If the participant chooses the "safe" square, they will earn a set amount of money ($0.25); if they choose the "risk" square, they have the possibility of winning up to $5.00 but also the possibility of losing up to $5.00. Across 40 trials, participants will be able to earn between $0 and $35. All events will be shown for 2 seconds with 2, 4, or 6 second jittered intervals between.

Eighth Task
Protected Sex Discounting Pre-Scan Portion
Ramy czasowe: Seventh Task

Participants will view 60 cards with an image of a clothed person, spread on a table in front of them so they can all be viewed at the same time. Participants will be instructed to select all the pictures of individuals who they would be willing to have casual sex with based on physical appearance if the circumstances were right. From the pictures of individuals who the participant indicated that they would have sex with, participants will be asked to select 1) the individual most and 2) least likely to have a STD, and 2) the individual they most and 4) least want to have sex with.

Seventh Task
HIV-Knowledge Questionnaire
Ramy czasowe: First Task

A 45-question self-report questionnaire that takes approximately 7 minutes to complete. It assesses how much the participant knows about how HIV is transmitted and prevented.

First Task
HIV Risk-Taking Behavior Scale
Ramy czasowe: Second Task

Assesses quantitatively both intravenous drug use and sexual HIV risk behaviors. This includes 11 questions about sharing and cleaning needles, number of sexual partners, condom use, and sex work. Each item is scored on a scale of 0-5 where higher scores indicate more HIV risk. It takes less than 10 minutes to administer. Scores on this measure will allow us to consider whether performance and neural correlates of the PSD task are related to actual HIV risk behaviors in our sample.

Second Task
HIV and Sexual Behaviors Interview
Ramy czasowe: Third Task

Used to collect additional information on HIV risk. This will include such topics as condom attitudes and negotiation, HIV testing and history of exposure, sexual activities, partner risk behaviors, and perceived risk. Information from this survey will allow us to consider whether performance and neural correlates of the PSD task are related to actual HIV risk behaviors in our sample.

Third Task
Balanced Inventory of Desirable Responding
Ramy czasowe: Fifth Task

This will be used to measure social desirability bias. It is a 40-question self-report questionnaire that measures self-deceptive positivity and impression management. Number of items with extremely high agreement indicates level of desirable responding. We will use this to identify participants who may have inaccurately responded to questions about sexual history and HIV risk due to a desire to represent themselves better, and thus, might potentially bias our results in some way.

Fifth Task

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Melanie L Schwandt, Ph.D., National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

18 marca 2021

Zakończenie podstawowe (Rzeczywisty)

2 kwietnia 2025

Ukończenie studiów (Rzeczywisty)

2 kwietnia 2025

Daty rejestracji na studia

Pierwszy przesłany

22 kwietnia 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 kwietnia 2020

Pierwszy wysłany (Rzeczywisty)

24 kwietnia 2020

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

23 października 2026

Ostatnia weryfikacja

15 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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