Alcohol and Implicit Process in Sexual Risk Behavior in MSM
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|ClinicalTrials.gov Identifier: NCT03361384|
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Drinking Sex Behavior Men||Drug: Alcohol Other: Placebo (non-alcoholic beverage)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants are randomly assigned to a beverage condition: alcohol, placebo, or control (water).|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Alcohol and Implicit Process in Sexual Risk Behavior in MSM|
|Actual Study Start Date :||May 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Experimental: Alcohol condition
The amount of alcohol received in the alcohol condition will be determined by an algorithm developed by Curtin (Curtin, 2000). Participants in the alcohol condition will receive a dose of alcohol (target BAC = .08%), administered in a chilled beverage of 80-proof vodka mixed with tonic water and lime juice in a 1:4 ratio.
Placebo Comparator: Placebo condition
Placebo participants will receive tonic water and lime juice served to enhance alcohol cues in an amount comparable to the amount that they would have received if assigned to the alcohol condition.
Other: Placebo (non-alcoholic beverage)
No Intervention: Control (water)
Participants in the water control condition will receive a glass of chilled water in volume of liquid comparable to the amount that they would have received if assigned to the alcohol or placebo condition.
- Risk exposure [ Time Frame: Post beverage administration (completed 30-45 minutes following beverage consumption) ]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 with Jim. Participants will receive 1 point for each time they answer "yes" and thus make a progressively risky choice. The risk exposure portion of the video will terminate with the first "no" response to the choice points. Subsequently, the participant will go to the fifth choice point to begin the behavioral skills component of the video. The risk exposure score will represent the mean score from the two interactive videos. Higher scores represent higher risk exposure scores.
- Behavioral skills [ Time Frame: Post beverage administration (completed 30-45 minutes following beverage consumption) ]The behavioral skills portion of the video will require participants to negotiate sexual situations using verbal communication skills in an interactive role-play. Participants will be asked to respond first to Jim's comment that he desires to have unprotected anal sex and that there is no cause for concern because he is safe ("prompt 1") and = a second, more insistent comment that was a reminder to the participant that UAI would not be risky and would be pleasurable and that the participants could trust Jim ("prompt 2"). Participants' responses to each of the prompts will be scored on a 0-2 scale (higher score = better communication skills). The behavioral skills score will represent the mean score from the two interactive videos.
- Intentions to engage in unprotected sex [ Time Frame: Post beverage administration (completed 30-45 minutes following beverage consumption) ]Intention to engage in unprotected sex after viewing each of two sexual video vignettes (Maisto et al., 2012) will be rated on a 7-point rating scale (Bishop & Maisto, 2011). The intentions to engage in unprotected sex score will represent the mean score from the two interactive videos. Higher scores represent greater intentions to engage in unprotected sex.
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): NCT03361384
|Contact: Steve A Maisto, PhD||(315) firstname.lastname@example.org|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02215|
|Contact: Tibor P.A. Palfai, PhD (617) 353-9345 email@example.com|
|United States, New York|
|Syracuse, New York, United States, 13244|
|Contact: Steve A Maisto, PhD 315-425-6546 firstname.lastname@example.org|
|United States, South Dakota|
|University of South Dakota||Active, not recruiting|
|Vermillion, South Dakota, United States, 57069|
|Principal Investigator:||Steve A Maisto, PhD||Syracuse University|
|Principal Investigator:||Jeffrey Simons, PhD||University of South Dakota|
|Principal Investigator:||Tibor P.A. Palfai, PhD||Boston University|