Does Oxytocin Alter Tolerance to or Motivation for Alcohol
NCT05312008, Phase 2, Terminated, Indiana University; results first posted 2025-03-04
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Does Oxytocin Alter Tolerance to or Motivation for Alcohol | ClinicalTrials.gov |
| NCT number | NCT05312008 | ClinicalTrials.gov |
| Status | Terminated | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 6 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Indiana University | ClinicalTrials.gov |
| Conditions | Alcohol Use Disorder | ClinicalTrials.gov |
| Interventions | Intranasal oxytocin, Intranasal placebo | ClinicalTrials.gov |
| First posted | 2022-04-05 | ClinicalTrials.gov |
| Last updated | 2025-03-04 | ClinicalTrials.gov |
| Results first posted | 2025-03-04 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Subjective Effect of Alcohol - Craving | 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced. | Participants rated their subjective feeling of craving on a scale of 0-100. Tolerance to alcohol is assessed by subtracting subjective ratings at the beginning of the 2 hour alcohol infusion from ratings at the end; a negative value indicates tolerance. Possible scores ranged from -100 to 100; negative scores indicate the development of tolerance. Values reported here compare tolerance developed during the oxytocin session to tolerance developed during the placebo session. | ClinicalTrials.gov |
| Primary | Subjective Effects of Alcohol - Intoxication | 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced. | Participants rated their subjective feeling of intoxication on a scale of 0-100. Tolerance to alcohol is assessed by subtracting subjective ratings at the beginning of the 2 hour alcohol infusion from ratings at the end. Using this calculation, theoretical scores in this dataset could range from -100-100; negative scores indicate the development of tolerance. Values reported here compare tolerance developed during the oxytocin session to tolerance developed during the placebo session. | ClinicalTrials.gov |
| Primary | Stop Signal Response Task | 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced. | The Stop Signal task asks participants to respond as quickly as they can to one stimulus (the "Go" signal) but withhold this response when a second, much rarer stimulus appears (the "Stop" signal). Performance reported here uses the variable ssRT Med, which is an estimate of the time (in ms) needed to stop and withdraw the response; alcohol is known to increase ssRT Med. To assess tolerance, the value of ssRT Med measured at the beginning of the 2 hour alcohol clamp was subtracted from the value measured at the end. The theoretical range of possible scores on this measure range from about -100 to 200; negative scores indicate the development of tolerance. Values reported here compare tolerance developed during the oxytocin session to tolerance developed during the placebo session. | ClinicalTrials.gov |
| Primary | Stroop Test | 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced. | The Stroop Interference task asks participants to respond to one aspect of a stimulus (in this case, the color of the text in which a word is printed) under conditions in which the word meaning either enhances or interferes with the task (for example, the word Green in a Green font speeds performance, while the word Green in a Yellow font slows performance). Tolerance to alcohol was assessed by subtracting response latency (ms) on correct trials at the beginning of the 2 hour alcohol infusion from latency on correct trials at the end. Theoretical scores ranged from about -200 to 250; negative scores indicate the development of tolerance. Values reported here compare tolerance developed during the oxytocin session to tolerance developed during the placebo session. | ClinicalTrials.gov |
| Primary | Alcohol Purchase Task (Variable OMax) | 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo | The Alcohol Purchase task (APT) tests the value participants place on alcohol at specific times and conditions of the experimental session. To complete the APT, participants fill out a table reporting how many drinks (allowed range 0-50) they would purchase during an evening out, for a cost ranging from $0 to $30/drink. From this, a value for # of drinks \* cost of drink is calculated; OMax is the highest amount in dollars that a participant would spend (possible range = $0 to $1,500). Tolerance to the effect of alcohol is calculated as OMax (end of infusion) - OMax (beginning of infusion), possible values range from -$1,500 to $1,500. Negative scores indicate the development of tolerance. Values reported here compare tolerance developed during the oxytocin session to tolerance developed during the placebo session. | ClinicalTrials.gov |
Outcomes 5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Subjective Effect of Alcohol - Craving | 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced. | All participants who completed both the oxytocin and placebo sessions were included. | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Subjective Effects of Alcohol - Intoxication | 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced. | All participants who completed both the Oxytocin and Placebo sessions are included in the analysis. | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Stop Signal Response Task | 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced. | All participants who completed both the Oxytocin and Placebo sessions are included in the analysis. | milliseconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Stroop Test | 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced. | All participants who completed both the Oxytocin and Placebo sessions are included in the analysis. | milliseconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Alcohol Purchase Task (Variable OMax) | 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo | All participants who completed both the Oxytocin and Placebo sessions are included in the analysis. | dollars | MEAN | ClinicalTrials.gov |
Results by group 10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Subjective Effect of Alcohol - Craving | Oxytocin Session (Clamp) | 1.6 | Standard Error 11.4 | units on a scale | ClinicalTrials.gov | |
| Subjective Effect of Alcohol - Craving | Placebo Session (Clamp) | 10.5 | Standard Error 10.3 | units on a scale | ClinicalTrials.gov | |
| Subjective Effects of Alcohol - Intoxication | Oxytocin Session (Clamp) | 1.0 | Standard Error 7.8 | units on a scale | ClinicalTrials.gov | |
| Subjective Effects of Alcohol - Intoxication | Placebo Session (Clamp) | 7.8 | Standard Error 13.2 | units on a scale | ClinicalTrials.gov | |
| Stop Signal Response Task | Oxytocin Session (Clamp) | -1.8 | Standard Error 18 | milliseconds | ClinicalTrials.gov | |
| Stop Signal Response Task | Placebo Session (Clamp) | -1.1 | Standard Error 8 | milliseconds | ClinicalTrials.gov | |
| Stroop Test | Oxytocin Session (Clamp) | -1.56 | Standard Error 13.3 | milliseconds | ClinicalTrials.gov | |
| Stroop Test | Placebo Session (Clamp) | -29.82 | Standard Error 13.1 | milliseconds | ClinicalTrials.gov | |
| Alcohol Purchase Task (Variable OMax) | Oxytocin Session (Clamp) | -1.0 | Standard Error 2.1 | dollars | ClinicalTrials.gov | |
| Alcohol Purchase Task (Variable OMax) | Placebo Session (Clamp) | -3.2 | Standard Error 2.2 | dollars | ClinicalTrials.gov |
Participant flow 12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Oxytocin First, Then Placebo (Clamp) | 3 | ClinicalTrials.gov | |
| Overall Study | STARTED | Placebo First, Then Oxytocin (Clamp) | 3 | ClinicalTrials.gov | |
| Overall Study | STARTED | Oxytocin First, Then Placebo (Progressive Work) | 0 | ClinicalTrials.gov | |
| Overall Study | STARTED | Placebo First, Then Oxytocin (Progressive Work) | 0 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Oxytocin First, Then Placebo (Clamp) | 3 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo First, Then Oxytocin (Clamp) | 3 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Oxytocin First, Then Placebo (Progressive Work) | 0 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo First, Then Oxytocin (Progressive Work) | 0 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Oxytocin First, Then Placebo (Clamp) | 0 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo First, Then Oxytocin (Clamp) | 0 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Oxytocin First, Then Placebo (Progressive Work) | 0 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo First, Then Oxytocin (Progressive Work) | 0 | ClinicalTrials.gov |
Adverse events 9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Nausea | General disorders | Oxytocin Session | 1 | 6 | 1 | ClinicalTrials.gov |
| other | Nausea | General disorders | Placebo | 0 | 6 | 0 | ClinicalTrials.gov |
| other | Nausea | General disorders | Between Session Interval | 0 | 6 | 0 | ClinicalTrials.gov |
| other | Headache | General disorders | Oxytocin Session | 1 | 6 | 1 | ClinicalTrials.gov |
| other | Headache | General disorders | Placebo | 4 | 6 | 4 | ClinicalTrials.gov |
| other | Headache | General disorders | Between Session Interval | 0 | 6 | 0 | ClinicalTrials.gov |
| other | Infected Toe | Skin and subcutaneous tissue disorders | Oxytocin Session | 0 | 6 | 0 | ClinicalTrials.gov |
| other | Infected Toe | Skin and subcutaneous tissue disorders | Placebo | 0 | 6 | 0 | ClinicalTrials.gov |
| other | Infected Toe | Skin and subcutaneous tissue disorders | Between Session Interval | 1 | 6 | 1 | ClinicalTrials.gov |
Adverse event totals 9
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Oxytocin Session | 0 | 6 | ClinicalTrials.gov |
| Total, all-cause mortality | Placebo | 0 | 6 | ClinicalTrials.gov |
| Total, all-cause mortality | Between Session Interval | 0 | 6 | ClinicalTrials.gov |
| Total, other adverse events | Oxytocin Session | 2 | 6 | ClinicalTrials.gov |
| Total, other adverse events | Placebo | 4 | 6 | ClinicalTrials.gov |
| Total, other adverse events | Between Session Interval | 1 | 6 | ClinicalTrials.gov |
| Total, serious adverse events | Oxytocin Session | 0 | 6 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo | 0 | 6 | ClinicalTrials.gov |
| Total, serious adverse events | Between Session Interval | 0 | 6 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Purchase Task | Primary outcome | ConductCognition |
| Stop-Signal Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)