Alcohol DrinkingPhase 1NCT03361384
Alcohol and Implicit Process in Sexual Risk Behavior in MSM
A Phase 1 study testing Alcohol in people with Alcohol Drinking and Sex Behavior, run by Syracuse University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Sex Behavior, Men
- What is being tested?
- Alcohol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2016to 30 Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Boston University
Boston, Massachusetts, 02215
Syracuse University
Syracuse, New York, 13244
University of South Dakota
Vermillion, South Dakota, 57069
About this study
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
- Being tested
- Alcohol, Placebo (non-alcoholic beverage)
- Keywords
- men who have sex with men
- Medical subject headings
- Alcohol Drinking, Sexual Behavior, Multiple Endocrine Neoplasia Type 1, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholDrug
Placebo (non-alcoholic beverage)Other
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Post beverage administration (completed 30-45 minutes following beverage consumption)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study startMay 2016
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to a beverage condition: alcohol, placebo, or control (water).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Boston University, University of South Dakota
- Responsible party
- Sponsor
- Investigators
- Steve A Maisto, PhD, Principal investigator, Syracuse UniversityJeffrey Simons, PhD, Principal investigator, University of South DakotaTibor P.A. Palfai, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361384
- Sponsor's protocol ID
- 14-068
- Other IDs
- R01AA022301
- Status last verified
- Jul 2021
- First submitted
- 20 Nov 2017
- Last updated
- 23 Jul 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol and Implicit Process in Sexual Risk Behavior in MSM
- ClinicalTrials.gov ID
- NCT03361384
- Acronym / sponsor ID
- 14-068
- Conditions
- Alcohol Drinking, Sex Behavior, Men
- Keywords
- men who have sex with men
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Boston University, University of South Dakota
- Study start
- May 2016 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 4 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to a beverage condition: alcohol, placebo, or control (water).
| Arm | Type | Receives |
|---|---|---|
| Alcohol condition | Experimental | Drug: AlcoholThe 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 condition | Placebo comparator | Other: Placebo (non-alcoholic beverage)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. |
| 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. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol | Drug | Alcohol condition |
| Placebo (non-alcoholic beverage) | Other | Placebo condition |
Primary outcome
Risk exposure
Time frame: Post beverage administration (completed 30-45 minutes following beverage consumption)
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
Time frame: Post beverage administration (completed 30-45 minutes following beverage consumption)
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
Time frame: Post beverage administration (completed 30-45 minutes following beverage consumption)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve A Maisto, PhD principal investigator
Syracuse University
Jeffrey Simons, PhD principal investigator
University of South Dakota
Tibor P.A. Palfai, PhD principal investigator
Boston University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alcohol in people with Alcohol Drinking and Sex Behavior, run by Syracuse University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk exposure (time frame: Post beverage administration (completed 30-45 minutes following beverage consumption)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.