Clinical trial NCT03361384: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Drinking
Sex Behavior
Men
Keywords: men who have sex with men
Lead sponsor: Syracuse University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Boston University
name: University of South Dakota
First posted: 2017-12-04
Enrollment: 260
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to a beverage condition: alcohol, placebo, or control (water).
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Risk exposure
timeFrame: Post beverage administration (completed 30-45 minutes following beverage consumption)
measure: Behavioral skills
timeFrame: Post beverage administration (completed 30-45 minutes following beverage consumption)
measure: Intentions to engage in unprotected sex
timeFrame: Post beverage administration (completed 30-45 minutes following beverage consumption)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Syracuse
country: United States
facility: Syracuse University
state: New York
city: Vermillion
country: United States
facility: University of South Dakota
state: South Dakota
Study officials:
affiliation: Syracuse University
name: Steve A Maisto, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Dakota
name: Jeffrey Simons, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Tibor P.A. Palfai, PhD
role: PRINCIPAL_INVESTIGATOR
References: