Status:

COMPLETED

Alcohol and Implicit Process in Sexual Risk Behavior in MSM

Lead Sponsor:

Syracuse University

Collaborating Sponsors:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Boston University

Conditions:

Alcohol Drinking

Sex Behavior

Eligibility:

MALE

21-50 years

Phase:

PHASE1

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 i...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 1 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 30 2020

Estimated Enrollment :

260 Patients enrolled

Trial Details

Trial ID

NCT03361384

Start Date

May 1 2016

End Date

June 30 2020

Last Update

July 23 2021

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Boston University

Boston, Massachusetts, United States, 02215

2

Syracuse University

Syracuse, New York, United States, 13244

3

University of South Dakota

Vermillion, South Dakota, United States, 57069