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NCT03361384 · ClinicalTrials.gov registry record · Phase 1
Alcohol and Implicit Process in Sexual Risk Behavior in MSM
A Phase 1 study, sponsored by Syracuse University.
- Completed
- Registry status
- Phase 1
- Development phase
- 260
- Enrollment target
NCT03361384: Completed Phase 1 study, sponsored by Syracuse University.
NCT03361384 is a Phase 1 study that has completed, run by Syracuse University. The registered enrollment target is 260 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (333% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03361384, a Phase 1 study, has completed, sponsored by Syracuse University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 260 participants
- Enrollment target
Study Summary
The current study is the first empirical investigation that directly addresses the correspondence between responses regarding indicators of risky sexual behavior while under the influence of alcohol in the laboratory and the occurrence of sexually risky behavior while under the influence of alcohol in the natural environment, by use of Ecological Sampling Methodology (ESM). The study will allow us to compare and contrast implicit and explicit assessments of sexual risk in respect to future behavior in the natural environment. The data obtained will thus provide new information regarding the external validity of alcohol administration studies of sexual risk behavior and will provide information to optimize the selection of dependent measures. The current study also represents the first attempt to test a causal model linking alcohol intoxication and risky sexual behavior as a function of both automatic, reflexive, approach tendencies and effortful, deliberative, self-control (operationalized by executive working memory in this application). The ESM study will augment the findings of the experiment by providing a detailed assessment of contextual factors that affect sexual risk behavior as well as replicating and extending the findings of the experiment to sexual risk situations in the natural environment. Finally, to our knowledge there has been only one experimental study of alcohol and sexual risk in MSM (Maisto, Palfai, Vanable, Heath, \& Woolf-King, 2012), which is remarkable given that MSM have been identified as the population at highest risk to contract the HIV in the U.S. since the virus was identified in the early 1980s. Thus the proposed research is only the second attempt to add to an understanding of the connections among alcohol, cognitive processes, and sexual risk behaviors in MSM.
Primary Outcome
Behavioral skills and risk exposure will be measured with two interactive videos developed for the Maisto et al. (2012) experiment. For the risk exposure component, each video begins by setting a scene in which "Jim" (the protagonist) and "Dave" (the character with whom the participant will be asked to identify) meet up with each other. The participant will be asked to make a series (5 choice points) of binary choices (yes/no) about engaging in various increasingly high-risk sexual activities wi
Interventions
- DRUG Alcohol
- OTHER Placebo (non-alcoholic beverage)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2016-05 |
| Est. Completion | 2020-06-30 |
| Phase | Phase 1 |
What the finished NCT03361384 record still lists
NCT03361384 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (333% higher).
The record links to 0 conditions, and to 2 interventions - of which Alcohol is the first listed.
NCT03361384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03361384 about?
NCT03361384 is a clinical study titled "Alcohol and Implicit Process in Sexual Risk Behavior in MSM". The current study is the first empirical investigation that directly addresses the correspondence between responses regarding indicators of risky sexual behavior while under the influence of alcohol in the laboratory and the occurrence of sexually risky behavior while under the influence of alcohol ...
What is the current status of trial NCT03361384?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 260 participants. The study started on 2016-05. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT03361384?
The interventions under investigation include: Alcohol (DRUG), Placebo (non-alcoholic beverage) (OTHER).
Who is sponsoring clinical trial NCT03361384?
This trial is sponsored by Syracuse University, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03361384's enrollment target sits among peer trials
260 160th of 2000 higher than 1,834 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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