An interventional study of Alcohol Intoxication- Ascending Limb and Alcohol Intoxication- Descending Limb in Alcohol Intoxication, sponsored by University of Colorado, Denver. Terminated at 1 site in United States. Open to participants aged 21 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Basic science
The goal of this experimental study is to examine the effect of alcohol, gender, and bystander attitudes on bystander barriers and sexual violence intervention among young adult men and women (age 21-20). The main questions it aims to answer are:
Participants will be randomly assigned to one of two beverage conditions (alcohol or control beverage) and those assigned to alcohol will complete the study on either the ascending or descending alcohol limb. Participants will project themselves into a heat-of-the moment, risky sexual violence scenario that will assess bystander barriers and behavioral intentions. Researchers will compare those assigned to the alcohol and control beverage condition and men/women to see if this impacts bystander barriers and sexual violence intervention.
76 studies on the registry are indexed under Alcoholic Intoxication; 17 are open to participants now.
This study's enrollment of 153 is above the median of 135 across 62 interventional studies indexed under Alcoholic Intoxication.
Browse Alcoholic Intoxication studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participant will receive alcohol, the dose of which will be administered to result in a breath alcohol concentration of .08%.
Behavioral: Alcohol Intoxication- Ascending Limb · Behavioral: Alcohol Intoxication- Descending Limb
Participant will receive a no alcohol control beverage, therefore their breath alcohol concentration will be .00%.
Behavioral: No Alcohol Control
Participants will be assigned to moderate alcohol dose condition (target breath alcohol concentration .08%) with NIAAA approved alcohol administration procedures and complete the study task on the ascending limb
Participants will be assigned to moderate alcohol dose condition (target breath alcohol concentration .08%) with NIAAA approved alcohol administration procedures and complete the study task on the descending limb
Participants will be assigned to a no alcohol control condition
Number of Participants With Articulated Thoughts of Barriers to Bystander Intervention
Number of participants with articulated thoughts in simulated situations is a proxy for understanding barriers to intervention. Participants' articulated thoughts were coded into the presence or absence of 5 barriers (Step 1: Notice the Situation, Step 2: Interpret the Situation as Risky or Concerning, Step 3: Take Responsibility, Step 4: I Don't Know What To Do, Step 5: Intervention) as seen in the table below.
Time frame: 1 hour post beverage consumption
Number of Participants That Articulated Thoughts of Intentions to Intervene as a Bystander
Number of participants that articulated thoughts to intervene in simulated situations is a proxy for understanding intervention intentions.
Time frame: 1 hour post beverage consumption
| Milestone | Alcohol Intoxication, Ascending Limb | No-Alcohol Control | Alcohol Intoxication, Descending Limb |
|---|---|---|---|
| Started | 52 | 50 | 51 |
| Completed | 52 | 50 | 51 |
| Not completed | 0 | 0 | 0 |
Number of participants with articulated thoughts in simulated situations is a proxy for understanding barriers to intervention. Participants' articulated thoughts were coded into the presence or absence of 5 barriers (Step 1: Notice the Situation, Step 2: Interpret the Situation as Risky or Concerning, Step 3: Take Responsibility, Step 4: I Don't Know What To Do, Step 5: Intervention) as seen in the table below.
| Participants | Alcohol Intoxication, Ascending Limb | No-Alcohol Control | Alcohol Intoxication, Descending Limb |
|---|---|---|---|
| Step 1- Absence or presence of noticing the situation — Failure to Notice the Situation | 6 | 6 | 5 |
| Step 1- Absence or presence of noticing the situation — Noticed the Situation | 39 | 40 | 39 |
| Step 1- Absence or presence of noticing the situation — Failure to Interpret the Situation as Risky or Concerning | 0 | 0 | 0 |
| Step 1- Absence or presence of noticing the situation — Interpreted the Situation as Risky or Concerning | 0 | 0 | 0 |
| Step 1- Absence or presence of noticing the situation — Failure to Take Responsibility | 0 | 0 | 0 |
| Step 1- Absence or presence of noticing the situation — Took Responsibility | 0 | 0 | 0 |
| Step 1- Absence or presence of noticing the situation — Failure to Know What to Do | 0 | 0 | 0 |
| Step 1- Absence or presence of noticing the situation — Knew What to Do | 0 | 0 | 0 |
| Step 1- Absence or presence of noticing the situation — Failure to Intervene | 0 | 0 | 0 |
| Step 1- Absence or presence of noticing the situation — Intervened | 0 | 0 | 0 |
| Step 2- Absence or presence of interpreting the situation as risky or concerning — Failure to Notice the Situation | 0 | 0 | 0 |
| Step 2- Absence or presence of interpreting the situation as risky or concerning — Noticed the Situation | 0 | 0 | 0 |
| Step 2- Absence or presence of interpreting the situation as risky or concerning — Failure to Interpret the Situation as Risky or Concerning | 0 | 0 | 0 |
| Step 2- Absence or presence of interpreting the situation as risky or concerning — Interpreted the Situation as Risky or Concerning | 45 | 46 | 44 |
| Step 2- Absence or presence of interpreting the situation as risky or concerning — Failure to Take Responsibility | 0 | 0 | 0 |
| Step 2- Absence or presence of interpreting the situation as risky or concerning — Took Responsibility | 0 | 0 | 0 |
| Step 2- Absence or presence of interpreting the situation as risky or concerning — Failure to Know What to Do | 0 | 0 | 0 |
| Step 2- Absence or presence of interpreting the situation as risky or concerning — Knew What to Do | 0 | 0 | 0 |
| Step 2- Absence or presence of interpreting the situation as risky or concerning — Failure to Intervene | 0 | 0 | 0 |
| Step 2- Absence or presence of interpreting the situation as risky or concerning — Intervened | 0 | 0 | 0 |
| Step 3- Absence or presence taking responsibility — Failure to Notice the Situation | 0 | 0 | 0 |
| Step 3- Absence or presence taking responsibility — Noticed the Situation | 0 | 0 | 0 |
| Step 3- Absence or presence taking responsibility — Failure to Interpret the Situation as Risky or Concerning | 0 | 0 | 0 |
| Step 3- Absence or presence taking responsibility — Interpreted the Situation as Risky or Concerning | 0 | 0 | 0 |
| Step 3- Absence or presence taking responsibility — Failure to Take Responsibility | 12 | 17 | 18 |
| Step 3- Absence or presence taking responsibility — Took Responsibility | 33 | 29 | 26 |
| Step 3- Absence or presence taking responsibility — Failure to Know What to Do | 0 | 0 | 0 |
| Step 3- Absence or presence taking responsibility — Knew What to Do | 0 | 0 | 0 |
| Step 3- Absence or presence taking responsibility — Failure to Intervene | 0 | 0 | 0 |
| Step 3- Absence or presence taking responsibility — Intervened | 0 | 0 | 0 |
| Step 4- Absence or presence of knowing what to do — Failure to Notice the Situation | 0 | 0 | 0 |
| Step 4- Absence or presence of knowing what to do — Noticed the Situation | 0 | 0 | 0 |
| Step 4- Absence or presence of knowing what to do — Failure to Interpret the Situation as Risky or Concerning | 0 | 0 | 0 |
| Step 4- Absence or presence of knowing what to do — Interpreted the Situation as Risky or Concerning | 0 | 0 | 0 |
| Step 4- Absence or presence of knowing what to do — Failure to Take Responsibility | 0 | 0 | 0 |
| Step 4- Absence or presence of knowing what to do — Took Responsibility | 0 | 0 | 0 |
| Step 4- Absence or presence of knowing what to do — Failure to Know What to Do | 40 | 43 | 42 |
| Step 4- Absence or presence of knowing what to do — Knew What to Do | 5 | 3 | 2 |
| Step 4- Absence or presence of knowing what to do — Failure to Intervene | 0 | 0 | 0 |
| Step 4- Absence or presence of knowing what to do — Intervened | 0 | 0 | 0 |
| Step 5- Absence or presence of intervening — Failure to Notice the Situation | 0 | 0 | 0 |
| Step 5- Absence or presence of intervening — Noticed the Situation | 0 | 0 | 0 |
| Step 5- Absence or presence of intervening — Failure to Interpret the Situation as Risky or Concerning | 0 | 0 | 0 |
| Step 5- Absence or presence of intervening — Interpreted the Situation as Risky or Concerning | 0 | 0 | 0 |
| Step 5- Absence or presence of intervening — Failure to Take Responsibility | 0 | 0 | 0 |
| Step 5- Absence or presence of intervening — Took Responsibility | 0 | 0 | 0 |
| Step 5- Absence or presence of intervening — Failure to Know What to Do | 0 | 0 | 0 |
| Step 5- Absence or presence of intervening — Knew What to Do | 0 | 0 | 0 |
| Step 5- Absence or presence of intervening — Failure to Intervene | 0 | 0 | 1 |
| Step 5- Absence or presence of intervening — Intervened | 45 | 46 | 43 |
Number of participants that articulated thoughts to intervene in simulated situations is a proxy for understanding intervention intentions.
| Participants | Alcohol Intoxication, Ascending Limb | No-Alcohol Control | Alcohol Intoxication, Descending Limb |
|---|---|---|---|
| Number of Participants That Articulated Thoughts of Intentions to Intervene as a Bystander | 45 | 46 | 43 |
Collected over Up to 8 hours. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alcohol Intoxication, Ascending Limb | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| No-Alcohol Control | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Alcohol Intoxication, Descending Limb | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Age, Continuous(Years) | Alcohol Intoxication, Ascending Limb | No-Alcohol Control | Alcohol Intoxication, Descending Limb | Total |
|---|---|---|---|---|
| Mean | 23.52 ± 2.49 | 24.31 ± 2.95 | 24.58 ± 2.92 | 24.13 ± 2.81 |
| Sex: Female, Male(Participants) | Alcohol Intoxication, Ascending Limb | No-Alcohol Control | Alcohol Intoxication, Descending Limb | Total |
|---|---|---|---|---|
| Female | 32 | 34 | 32 | 98 |
| Male | 20 | 16 | 19 | 55 |
| Race (NIH/OMB)(Participants) | Alcohol Intoxication, Ascending Limb | No-Alcohol Control | Alcohol Intoxication, Descending Limb | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 | 2 |
| Asian | 7 | 8 | 8 | 23 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 17 | 20 | 23 | 60 |
| White | 21 | 12 | 17 | 50 |
| More than one race | 5 | 6 | 2 | 13 |
| Unknown or Not Reported | 2 | 3 | 0 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Alcohol Intoxication, Ascending Limb | No-Alcohol Control | Alcohol Intoxication, Descending Limb | Total |
|---|---|---|---|---|
| Hispanic or Latino | 10 | 8 | 8 | 26 |
| Not Hispanic or Latino | 42 | 39 | 43 | 124 |
| Unknown or Not Reported | 0 | 3 | 0 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD will be available in the NIAAA Data Archive.
Ran from Mar 2023 to primary completion in Aug 2024, 17 months.
Results were first posted in Sep 2026, 2 years 1 month after primary completion.
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