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Alcohol and Implicit Process in Sexual Risk Behavior in MSM

Primary Purpose

Alcohol Drinking, Sex Behavior, Men

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Alcohol

Placebo (non-alcoholic beverage)

About this trial

This is an interventional basic science trial for Alcohol Drinking focused on measuring men who have sex with men

Eligibility Criteria

21 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Participants must be between the ages of 21-50
Moderate or heavy drinkers based on classifications from the Quantity-Frequency-Variability Questionnaire (QFV; Cahalan, Cisin, & Crossley, 1969)
Self-identify with the sexual orientation equivalent of a 3 or higher on the Kinsey Scale (Kinsey et al., 1948; Kinsey et al., 1953), a 7-point scale used to assess self-identified sexual orientation, with zero representing exclusive heterosexuality and 6 representing exclusive homosexuality.
Participants must also have engaged in sex with other men at least once/month for the past 3 months.

Exclusion Criteria:

a) under the age of 21 or b) do not have a government issued ID or c) are not able to provide medical records or other official documents with a birthdate (e.g., birth certificate), accompanied by a photo ID
Scores ≥ 5 on the Brief Michigan Alcoholism Screening Test (Brief MAST; Pokorny, Miller, & Kaplan, 1972)
Any ASSIST substance involvement score of ≥ 27 (National Institute on Drug Abuse; http://www.drugabuse.gov/sites/default/files/pdf/nmassist.pdf)
Score ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8; Kroenke et al., 2009)
4 subscales of the Brief Symptom Inventory (BSI; Derogatis & Melisaratos, 1979), Somatization, Obsession-compulsion, Paranoid ideation, and Psychoticism will be administered; Individuals experiencing severe psychological health symptoms (score > 2 on any item) will be further questioned by a research assistant in order to determine if there is psychiatric distress or problems present
Report current medications or current medical problems (e.g., liver disorders, heart disease, HIV+ serostatus) that contraindicate alcohol use using the Medical Condition Questionnaire; Participants who confirm that they are using (i.e., have used in the past week) any prescribed drugs for which alcohol use is contraindicated (http://www.nlm.nih.gov/medlineplus/druginfo/drug_Aa.html) will be excluded. Participants also currently regularly taking (i.e., past 24 hours) any herbals and vitamins, including sleep aids (chamomile) and herbal preparations for anxiety and depression (Kava Kava or St. John's Wort) that contraindicate alcohol use will be excluded
Persons with cognitive and or psychomotor deficits will be excluded from the experiment (based on RA and PI determination)
Endorse currently being in a committed, exclusive monogamous relationship
Report treatment for emotional or substance use disorders (defined by current treatment or treatment in the past 3 months) or recent history of significant alcohol problems as indicated by inpatient/outpatient alcohol treatment or alcohol self-help group attendance (e.g., AA) within the past 3 years.

Sites / Locations

Boston University
Syracuse University
University of South Dakota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Alcohol condition

Placebo condition

Control (water)

Arm Description

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 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.

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.

Outcomes

Primary Outcome Measures

Risk exposure

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

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03361384

First Posted

November 20, 2017

Last Updated

July 22, 2021

Sponsor

Syracuse University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA), Boston University, University of South Dakota

1. Study Identification

Unique Protocol Identification Number

NCT03361384

Brief Title

Alcohol and Implicit Process in Sexual Risk Behavior in MSM

Official Title

Alcohol and Implicit Process in Sexual Risk Behavior in MSM

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

May 2016 (Actual)

Primary Completion Date

June 30, 2020 (Actual)

Study Completion Date

June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Syracuse University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA), Boston University, University of South Dakota

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Drinking, Sex Behavior, Men

Keywords

men who have sex with men

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Participants are randomly assigned to a beverage condition: alcohol, placebo, or control (water).

Masking

ParticipantOutcomes Assessor

Masking Description

Double (Participant, Outcomes Assessor)

Allocation

Randomized

Enrollment

260 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alcohol condition

Arm Type

Experimental

Arm Description

Arm Title

Placebo condition

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Control (water)

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Alcohol

Intervention Type

Other

Intervention Name(s)

Placebo (non-alcoholic beverage)

Primary Outcome Measure Information:

Title

Risk exposure

Description

Time Frame

Post beverage administration (completed 30-45 minutes following beverage consumption)

Title

Behavioral skills

Description

Time Frame

Post beverage administration (completed 30-45 minutes following beverage consumption)

Title

Intentions to engage in unprotected sex

Description

Time Frame

Post beverage administration (completed 30-45 minutes following beverage consumption)

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants must be between the ages of 21-50 Moderate or heavy drinkers based on classifications from the Quantity-Frequency-Variability Questionnaire (QFV; Cahalan, Cisin, & Crossley, 1969) Self-identify with the sexual orientation equivalent of a 3 or higher on the Kinsey Scale (Kinsey et al., 1948; Kinsey et al., 1953), a 7-point scale used to assess self-identified sexual orientation, with zero representing exclusive heterosexuality and 6 representing exclusive homosexuality. Participants must also have engaged in sex with other men at least once/month for the past 3 months. Exclusion Criteria: a) under the age of 21 or b) do not have a government issued ID or c) are not able to provide medical records or other official documents with a birthdate (e.g., birth certificate), accompanied by a photo ID Scores ≥ 5 on the Brief Michigan Alcoholism Screening Test (Brief MAST; Pokorny, Miller, & Kaplan, 1972) Any ASSIST substance involvement score of ≥ 27 (National Institute on Drug Abuse; http://www.drugabuse.gov/sites/default/files/pdf/nmassist.pdf) Score ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8; Kroenke et al., 2009) 4 subscales of the Brief Symptom Inventory (BSI; Derogatis & Melisaratos, 1979), Somatization, Obsession-compulsion, Paranoid ideation, and Psychoticism will be administered; Individuals experiencing severe psychological health symptoms (score > 2 on any item) will be further questioned by a research assistant in order to determine if there is psychiatric distress or problems present Report current medications or current medical problems (e.g., liver disorders, heart disease, HIV+ serostatus) that contraindicate alcohol use using the Medical Condition Questionnaire; Participants who confirm that they are using (i.e., have used in the past week) any prescribed drugs for which alcohol use is contraindicated (http://www.nlm.nih.gov/medlineplus/druginfo/drug_Aa.html) will be excluded. Participants also currently regularly taking (i.e., past 24 hours) any herbals and vitamins, including sleep aids (chamomile) and herbal preparations for anxiety and depression (Kava Kava or St. John's Wort) that contraindicate alcohol use will be excluded Persons with cognitive and or psychomotor deficits will be excluded from the experiment (based on RA and PI determination) Endorse currently being in a committed, exclusive monogamous relationship Report treatment for emotional or substance use disorders (defined by current treatment or treatment in the past 3 months) or recent history of significant alcohol problems as indicated by inpatient/outpatient alcohol treatment or alcohol self-help group attendance (e.g., AA) within the past 3 years.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steve A Maisto, PhD

Organizational Affiliation

Syracuse University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jeffrey Simons, PhD

Organizational Affiliation

University of South Dakota

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tibor P.A. Palfai, PhD

Organizational Affiliation

Boston University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston University

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Syracuse University

City

Syracuse

State/Province

New York

ZIP/Postal Code

13244

Country

United States

Facility Name

University of South Dakota

City

Vermillion

State/Province

South Dakota

ZIP/Postal Code

57069

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Alcohol and Implicit Process in Sexual Risk Behavior in MSM

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