Alcohol and Implicit Process in Sexual Risk Behavior in MSM

NCT ID: NCT03361384

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2020-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Alcohol

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo (non-alcoholic beverage)

Intervention Type: OTHER

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Alcohol

Intervention Type: DRUG

Placebo (non-alcoholic beverage)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

University of South Dakota

OTHER

Sponsor Role: collaborator

Syracuse University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve A Maisto, PhD

Role: PRINCIPAL_INVESTIGATOR

Syracuse University

Jeffrey Simons, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Dakota

Tibor P.A. Palfai, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston University

Boston, Massachusetts, United States

Syracuse University

Syracuse, New York, United States

University of South Dakota

Vermillion, South Dakota, United States

Countries

United States

Other Identifiers

R01AA022301

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-068

Identifier Type: -

Identifier Source: org_study_id