Recruiting

Observational Study

Sponsor:

Brown University

Code:

NCT03224416

Conditions

Binge Drinking

Unsafe Sex

HIV/AIDS

Sexually Transmitted Diseases

Eligibility Criteria

Sex: Male

Age: 21 - 35

Healthy Volunteers: Accepted

Interventions

Alcohol Administration

Placebo Alcohol Administration

No Alcohol Administration

Study Details

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.

Conditions

Binge Drinking

Unsafe Sex

HIV/AIDS

Sexually Transmitted Diseases

Study ID

NCT03224416

Start date

May 1, 2017

Status verified date

Jul, 2017

Completion date

Feb 28, 2019

Anticipated

Primary completion date

Feb 28, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 21 - 35

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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 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.

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 measure

  • Sexual Partner Delay Discounting Task [ Time Frame: Approximately 20-30 minutes after beverage administration within our single-session, lab-based protocol. ]
  • Sex Discounting Task [ Time Frame: Approximately 20-30 minutes after beverage administration within our single-session, lab-based protocol. ]
  • Condomless Anal Sex Intentions [ Time Frame: Approximately 45-50 minutes after beverage administration within our single-session, lab-based protocol. ]

Central Contacts and Locations

Central contacts

Locations

Center for Alcohol and Addiction Studies

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

More Information

Sponsor

Brown University

Last update posted

Jul 21, 2017

Last verified

Jul, 2017

Keywords

  • Alcohol
  • Delay Discounting
  • Risky Sexual Behavior
  • Decision Making
  • MSM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brown University on 2017-07-21.