Alcohol and Implicit Process in Sexual Risk Behavior in MSM

NCT03361384 | Completed Phase 1 FDA Drug

• 2 other identifiers: 14-068R01AA022301
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 3

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.

Conditions

Alcohol Drinking; Sex Behavior; Men

Keywords

men who have sex with men

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Study Arms (3)

Alcohol condition

EXPERIMENTAL

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.

Drug: Alcohol

Placebo condition

PLACEBO COMPARATOR

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)

Control (water)

NO INTERVENTION

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.

Interventions

Alcohol DRUG

Alcohol condition

Placebo (non-alcoholic beverage) OTHER

Placebo condition

Eligibility Criteria

• Age: 21 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Syracuse University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Boston University: collaborator
• University of South Dakota: collaborator

Study Sites (3)

Boston University

Boston, Massachusetts, 02215, United States

Location

Syracuse University

Syracuse, New York, 13244, United States

Location

University of South Dakota

Vermillion, South Dakota, 57069, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Sexual Behavior; Multiple Endocrine Neoplasia Type 1; Homosexuality

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Sexuality

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Steve A Maisto, PhD

  Syracuse University

  PRINCIPAL INVESTIGATOR

• Jeffrey Simons, PhD

  University of South Dakota

  PRINCIPAL INVESTIGATOR

• Tibor P.A. Palfai, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 4, 2017
• Study Start: May 1, 2016
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

US (3)