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Trial record 57 of 533 for:    Taste Disorders AND taste

Individual and Contextual Factors That Influence Sexual Decisions

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ClinicalTrials.gov Identifier: NCT03224416
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Mark Celio, Brown University

Brief Summary:

For decades, men who have sex with men (MSM) have carried the heaviest burden associated with the HIV epidemic in the United States. Although MSM represent a minority (i.e., approximately 4%) of the male population in the United States, in 2010 MSM accounted for 78% of new HIV infections among males. Furthermore, the estimated number of new HIV infections attributed to male-to-male sexual contact is currently rising. In order to improve interventions to decrease transmission of HIV among MSM, it is important to have a better understanding of predictors of risky sexual behavior. Alcohol use is among the most reliable predictors of risky sexual behavior. Unfortunately, studies of alcohol use and risky sex among MSM have mainly relied on survey-based methods that cannot advance our understanding of the causal mechanisms linking acute alcohol use to HIV risk behavior.

This study will utilize an "alcohol/placebo/nonalcohol" design to examine the mechanisms underlying the association between the acute effects of alcohol (i.e., pharmacological and expectancy) and risky sexual decision making in MSM. Focal mechanisms include sex-specific delay discounting (SSDD), and the core constructs of the Cognitive Mediation Model. The alcohol/placebo/nonalcohol design involves three conditions. In the alcohol condition (target BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in his presence. In the placebo condition (target BrAC = 0.000g%), the participant will be told he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from a vodka bottle) and tonic water, with a minimal amount of vodka "floated" on the surface (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and mint, all mixed in his presence and served in glasses with vodka-soaked rims. In the true control (or nonalcohol) condition, the participant will be told he is receiving no alcohol and will be given water (poured in his presence) in a volume comparable to the other conditions. This 3-group design will enable us to test the pharmacological effects of alcohol while accounting for potential expectancy effects. Participants (Target N = 150-180) will be randomly assigned to one condition; all will undergo the same protocol, which will be completed within one experimental session. The study protocol consists of baseline assessment, followed by beverage administration, followed by post-drinking assessment of SSDD and sexual decision making, followed by debriefing.


Condition or disease Intervention/treatment Phase
Binge Drinking Unsafe Sex HIV/AIDS Sexually Transmitted Diseases Other: Alcohol Administration Other: Placebo Alcohol Administration Other: No Alcohol Administration Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The alcohol/placebo/nonalcohol design involves three conditions. In the alcohol condition (target BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in his presence. In the placebo condition (target BrAC = 0.000g%), the participant will be told he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from a vodka bottle) and tonic water, with a minimal amount of vodka "floated" on the surface (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and mint, all mixed in his presence and served in glasses with vodka-soaked rims. In the true control (or nonalcohol) condition, the participant will be told he is receiving no alcohol and will be given water (poured in his presence) in a volume comparable to the other conditions.
Masking: Single (Participant)
Masking Description: Masking only applies to those participants who are randomly assigned to the placebo condition, which is described in detail above.
Primary Purpose: Basic Science
Official Title: Effects of Acute Alcohol on Sex-Specific Delay Discounting and Subsequent Sexual Decision Making Among MSM
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Arm Intervention/treatment
Experimental: Alcohol
In the alcohol condition (target BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in his presence.
Other: Alcohol Administration
In the alcohol condition (target BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in his presence.

Placebo Comparator: Placebo
In the placebo condition (target BrAC = 0.000g%), the participant will be told he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from a vodka bottle) and tonic water, with a minimal amount of vodka "floated" on the surface (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and mint, all mixed in his presence and served in glasses with vodka-soaked rims.
Other: Placebo Alcohol Administration
In the placebo condition (target BrAC = 0.000g%), the participant will be told he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from a vodka bottle) and tonic water, with a minimal amount of vodka "floated" on the surface (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and mint, all mixed in his presence and served in glasses with vodka-soaked rims.

Sham Comparator: True Control
In the true control (or nonalcohol) condition, the participant will be told he is receiving no alcohol and will be given water (poured in his presence) in a volume comparable to the other conditions.
Other: No Alcohol Administration
In the true control (or nonalcohol) condition, the participant will be told he is receiving no alcohol and will be given water (poured in his presence) in a volume comparable to the other conditions.




Primary Outcome Measures :
  1. Sexual Partner Delay Discounting Task [ Time Frame: Approximately 20-30 minutes after beverage administration within our single-session, lab-based protocol. ]
    This delay discounting task measures hypothetical choice preference for immediately available sexual partners versus delayed but more attractive sexual partners. Data collected across 35 items is used to calculate a discounting rate, with a higher rate suggesting a more impulsive preference for immediate sexual activity.

  2. Sex Discounting Task [ Time Frame: Approximately 20-30 minutes after beverage administration within our single-session, lab-based protocol. ]
    This discounting task measures the degree to which the value of hypothetical condom-protected sex decreases as a product of the amount of time one would have to wait for a condom to be available. Data collected across 32 items is used to calculate a discounting rate, with a higher rate suggesting a more impulsive preference for immediate and condomless sexual activity.

  3. Condomless Anal Sex Intentions [ Time Frame: Approximately 45-50 minutes after beverage administration within our single-session, lab-based protocol. ]
    In the context of this laboratory-based experiment, participants read a hypothetical scenario depicting a sexual interaction with a casual sexual partner. Intention to have condomless anal sex with this partner is assessed in the middle and at the end of this scenario. Intention is rates as "yes" or "no" in response to the question "In this situation, do you have anal sex with [this partner] without a condom?"


Secondary Outcome Measures :
  1. Perceived Sex Potential [ Time Frame: Approximately 35 minutes after beverage administration within our single-session, lab-based protocol. ]
    In the context of this laboratory-based experiment, participants read a hypothetical scenario depicting a sexual interaction with a casual sexual partner. Perceives sex potential is assessed at the beginning of the scenario by asking "In this scenario, how likely are you to have sex tonight?" Participants respond using an 11-point scale with "0" anchored at "not at all likely" and "10" anchored at "very likely."

  2. Perceived Sexual Risks and Benefits Scale [ Time Frame: Approximately 40 minutes after beverage administration within our single-session, lab-based protocol. ]
    In the context of this laboratory-based experiment, participants read a hypothetical scenario depicting a sexual interaction with a casual sexual partner. Within the scenario, participants are asked "When thinking about whether or not to have sex with this partner tonight, would you consider each of the following reasons? Please mark YES if you would consider the reason, and NO if you would not consider it in this situation." The list comprises 34 items, including 17 perceived risks and 17 perceived benefits. For each risk and benefit endorsed, participants also rate the extent to which the reason would influence their decision using a 5-point scale, with "0" anchored at "not influential and "5" anchored at "extremely influential."

  3. Online Sexual Communication [ Time Frame: Approximately 45 minutes after beverage administration within our single-session, lab-based protocol. ]
    In the context of this laboratory-based experiment, participants read a hypothetical scenario depicting a sexual interaction with a casual sexual partner. During the scenario, the participant is asked "At this point in the story, would you want to talk about anything else before agreeing to meet?" Participants who answer"yes" are then asked "What else you would want to talk about? Please use the text boxes below to describe what else you want to talk about." Responses are open ended. Finally, participants are asked "Each of the topics you want to discuss with this partner are listed below. For each, please write down exactly how you would ask this partner on Grindr. If you would use emoji in your message, please describe which ones?" Again, responses are open ended. These data are qualitative in nature.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cisgender males
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • single (i.e., not in a mutually monogamous relationship for at least 3 months)
  • sexually active as defined by any anal sex (i.e., receptive or insertive) with another man in the past 12 months
  • have had condomless anal sex with a male partner in their lifetime
  • have had at least one sexual encounter with a male partner met online in their lifetime
  • characterized as a current heavy drinker, as defined by self-report of one or more episodes of heavy drinking (i.e., ≥5 standard drinks in a single occasion) during the past 30 days; and 5) HIV negative, based on self-report.

Exclusion Criteria:

  • Non-drinkers and light to moderate drinkers
  • Individuals with current alcohol problems (as indexed by an AUDIT score ≥16)
  • Individuals with current drug problems (as indexed by a DAST score ≥6)
  • Females (as this is a study of men who have sex with men).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224416


Contacts
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Contact: Mark A Celio, PhD 401-863-6662 mark_celio@brown.edu
Contact: Jamie Hendrickson 401-863-6665 jamie_hendickson@brown.edu

Locations
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United States, Rhode Island
Center for Alcohol and Addiction Studies Recruiting
Providence, Rhode Island, United States, 02912
Contact: Mark A Celio, Ph.D.    401-863-6662    mark_celio@brown.edu   
Contact: Jamie Hendrickson    4018636665    jamie_hendrickson@brown.edu   
Sponsors and Collaborators
Brown University
Investigators
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Principal Investigator: Mark A Celio, PhD 1979

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Responsible Party: Mark Celio, Assistant Professor (Research), Brown University
ClinicalTrials.gov Identifier: NCT03224416     History of Changes
Other Study ID Numbers: Project Now (Phase II)
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Mark Celio, Brown University:
Alcohol
Delay Discounting
Risky Sexual Behavior
Decision Making
MSM

Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Binge Drinking
Infection
Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs