Trial Outcomes & Findings for Does Oxytocin Alter Tolerance to or Motivation for Alcohol (NCT NCT05312008)

NCT ID: NCT05312008

Last Updated: 2025-03-04

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced.

Results posted on

2025-03-04

Participant Flow

Potential participants were contacted from our lab's recruiting database. Recruiting was active between January and May, 2022, and between October and November, 2023.

Due to complications delaying the availability of the intranasal oxytocin and IV alcohol solutions needed for this project, we were unable to complete subjects in the self-administration arm of this study

Participant milestones

Participant milestones
Measure	Oxytocin First, Then Placebo (Clamp) Clamped alcohol exposure, repeated tests of subjective and cognitive effects of alcohol, 2 sessions (intranasal oxytocin or placebo), double blind Intranasal oxytocin: Initial dose 40 IU in 1 ml; 2 booster doses of 24 IU in 0.6 mls each, spaced about 1 hour apart Intranasal placebo: Initial volume 1 ml; 2 booster volumes of 0.6 mls each, spaced about 1 hour apart	Placebo First, Then Oxytocin (Clamp) Clamped alcohol exposure, repeated tests of subjective and cognitive effects of alcohol, 2 sessions (intranasal oxytocin or placebo), double blind Intranasal oxytocin: Initial dose 40 IU in 1 ml; 2 booster doses of 24 IU in 0.6 mls each, spaced about 1 hour apart Intranasal placebo: Initial volume 1 ml; 2 booster volumes of 0.6 mls each, spaced about 1 hour apart
Overall Study STARTED	3	3
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does Oxytocin Alter Tolerance to or Motivation for Alcohol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=6 Participants Demographic information is provided for all 6 participants combined. All 6 subjects participated in the clamp arm. The self-administration arm was not completed (see Overall Status). 3 participants had the Oxytocin session first, then Placebo; the other 3 had the reverse order (Placebo then Oxytocin).
Age, Continuous	35.5 Years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced.

Population: All participants who completed both the oxytocin and placebo sessions were included.

Outcome measures

Outcome measures
Measure	Oxytocin Session (Clamp) n=6 Participants Measurements acquired during the Oxytocin Session	Placebo Session (Clamp) n=6 Participants Measurements acquired during the placebo session
Subjective Effect of Alcohol - Craving	1.6 units on a scale Standard Error 11.4	10.5 units on a scale Standard Error 10.3

PRIMARY outcome

Timeframe: 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced.

Population: All participants who completed both the Oxytocin and Placebo sessions are included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Oxytocin Session (Clamp) n=6 Participants Measurements acquired during the Oxytocin Session	Placebo Session (Clamp) n=6 Participants Measurements acquired during the placebo session
Subjective Effects of Alcohol - Intoxication	1.0 units on a scale Standard Error 7.8	7.8 units on a scale Standard Error 13.2

PRIMARY outcome

Timeframe: 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced.

Population: All participants who completed both the Oxytocin and Placebo sessions are included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Oxytocin Session (Clamp) n=6 Participants Measurements acquired during the Oxytocin Session	Placebo Session (Clamp) n=6 Participants Measurements acquired during the placebo session
Stop Signal Response Task	-1.8 milliseconds Standard Error 18	-1.1 milliseconds Standard Error 8

PRIMARY outcome

Timeframe: 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo, scheduled 3-4 weeks apart, order counter-balanced.

Population: All participants who completed both the Oxytocin and Placebo sessions are included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Oxytocin Session (Clamp) n=6 Participants Measurements acquired during the Oxytocin Session	Placebo Session (Clamp) n=6 Participants Measurements acquired during the placebo session
Stroop Test	-1.56 milliseconds Standard Error 13.3	-29.82 milliseconds Standard Error 13.1

PRIMARY outcome

Timeframe: 2 single day laboratory sessions, one with intranasal oxytocin, one with intranasal placebo

Population: All participants who completed both the Oxytocin and Placebo sessions are included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Oxytocin Session (Clamp) n=6 Participants Measurements acquired during the Oxytocin Session	Placebo Session (Clamp) n=6 Participants Measurements acquired during the placebo session
Alcohol Purchase Task (Variable OMax)	-1.0 dollars Standard Error 2.1	-3.2 dollars Standard Error 2.2

Adverse Events

Oxytocin Session

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Between Session Interval

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Oxytocin Session n=6 participants at risk Measurements acquired during the Oxytocin Session	Placebo n=6 participants at risk Measurements acquired during the placebo session	Between Session Interval n=6 participants at risk Events occurring between the first and second session day
General disorders Nausea	16.7% 1/6 • Number of events 1 • Adverse event data were collected during 3 time periods: Oxytocin session day (~12 hours from arrival at to dismissal from Clinical Research Center) Between session day interval (21-28 days) Placebo session day (~12 hours from arrival at to dismissal from Clinical Research Center) Adverse event data were collected during the sessions by tracking expected oxytocin side-effects at each testing block. Specific symptoms monitored included dizziness, dry mouth, runny nose, stomach pain, nausea, headache, or any other unusual feeling. Adverse events were also collected unsystematically by asking the subject to report on their wellbeing and any unusual symptoms at study day intake, during the session, and during the post-session recovery period (3-6 hours).	0.00% 0/6 • Adverse event data were collected during 3 time periods: Oxytocin session day (~12 hours from arrival at to dismissal from Clinical Research Center) Between session day interval (21-28 days) Placebo session day (~12 hours from arrival at to dismissal from Clinical Research Center) Adverse event data were collected during the sessions by tracking expected oxytocin side-effects at each testing block. Specific symptoms monitored included dizziness, dry mouth, runny nose, stomach pain, nausea, headache, or any other unusual feeling. Adverse events were also collected unsystematically by asking the subject to report on their wellbeing and any unusual symptoms at study day intake, during the session, and during the post-session recovery period (3-6 hours).	0.00% 0/6 • Adverse event data were collected during 3 time periods: Oxytocin session day (~12 hours from arrival at to dismissal from Clinical Research Center) Between session day interval (21-28 days) Placebo session day (~12 hours from arrival at to dismissal from Clinical Research Center) Adverse event data were collected during the sessions by tracking expected oxytocin side-effects at each testing block. Specific symptoms monitored included dizziness, dry mouth, runny nose, stomach pain, nausea, headache, or any other unusual feeling. Adverse events were also collected unsystematically by asking the subject to report on their wellbeing and any unusual symptoms at study day intake, during the session, and during the post-session recovery period (3-6 hours).
General disorders Headache	16.7% 1/6 • Number of events 1 • Adverse event data were collected during 3 time periods: Oxytocin session day (~12 hours from arrival at to dismissal from Clinical Research Center) Between session day interval (21-28 days) Placebo session day (~12 hours from arrival at to dismissal from Clinical Research Center) Adverse event data were collected during the sessions by tracking expected oxytocin side-effects at each testing block. Specific symptoms monitored included dizziness, dry mouth, runny nose, stomach pain, nausea, headache, or any other unusual feeling. Adverse events were also collected unsystematically by asking the subject to report on their wellbeing and any unusual symptoms at study day intake, during the session, and during the post-session recovery period (3-6 hours).	66.7% 4/6 • Number of events 4 • Adverse event data were collected during 3 time periods: Oxytocin session day (~12 hours from arrival at to dismissal from Clinical Research Center) Between session day interval (21-28 days) Placebo session day (~12 hours from arrival at to dismissal from Clinical Research Center) Adverse event data were collected during the sessions by tracking expected oxytocin side-effects at each testing block. Specific symptoms monitored included dizziness, dry mouth, runny nose, stomach pain, nausea, headache, or any other unusual feeling. Adverse events were also collected unsystematically by asking the subject to report on their wellbeing and any unusual symptoms at study day intake, during the session, and during the post-session recovery period (3-6 hours).	0.00% 0/6 • Adverse event data were collected during 3 time periods: Oxytocin session day (~12 hours from arrival at to dismissal from Clinical Research Center) Between session day interval (21-28 days) Placebo session day (~12 hours from arrival at to dismissal from Clinical Research Center) Adverse event data were collected during the sessions by tracking expected oxytocin side-effects at each testing block. Specific symptoms monitored included dizziness, dry mouth, runny nose, stomach pain, nausea, headache, or any other unusual feeling. Adverse events were also collected unsystematically by asking the subject to report on their wellbeing and any unusual symptoms at study day intake, during the session, and during the post-session recovery period (3-6 hours).
Skin and subcutaneous tissue disorders Infected Toe	0.00% 0/6 • Adverse event data were collected during 3 time periods: Oxytocin session day (~12 hours from arrival at to dismissal from Clinical Research Center) Between session day interval (21-28 days) Placebo session day (~12 hours from arrival at to dismissal from Clinical Research Center) Adverse event data were collected during the sessions by tracking expected oxytocin side-effects at each testing block. Specific symptoms monitored included dizziness, dry mouth, runny nose, stomach pain, nausea, headache, or any other unusual feeling. Adverse events were also collected unsystematically by asking the subject to report on their wellbeing and any unusual symptoms at study day intake, during the session, and during the post-session recovery period (3-6 hours).	0.00% 0/6 • Adverse event data were collected during 3 time periods: Oxytocin session day (~12 hours from arrival at to dismissal from Clinical Research Center) Between session day interval (21-28 days) Placebo session day (~12 hours from arrival at to dismissal from Clinical Research Center) Adverse event data were collected during the sessions by tracking expected oxytocin side-effects at each testing block. Specific symptoms monitored included dizziness, dry mouth, runny nose, stomach pain, nausea, headache, or any other unusual feeling. Adverse events were also collected unsystematically by asking the subject to report on their wellbeing and any unusual symptoms at study day intake, during the session, and during the post-session recovery period (3-6 hours).	16.7% 1/6 • Number of events 1 • Adverse event data were collected during 3 time periods: Oxytocin session day (~12 hours from arrival at to dismissal from Clinical Research Center) Between session day interval (21-28 days) Placebo session day (~12 hours from arrival at to dismissal from Clinical Research Center) Adverse event data were collected during the sessions by tracking expected oxytocin side-effects at each testing block. Specific symptoms monitored included dizziness, dry mouth, runny nose, stomach pain, nausea, headache, or any other unusual feeling. Adverse events were also collected unsystematically by asking the subject to report on their wellbeing and any unusual symptoms at study day intake, during the session, and during the post-session recovery period (3-6 hours).

Additional Information

Dr. Ann E.K. Kosobud

Indiana University

Phone: 3172740087

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place