Trial Outcomes & Findings for Oxytocin, Alcohol Craving, and Intimate Partner Aggression (NCT NCT03046836)
NCT ID: NCT03046836
Last Updated: 2022-05-09
Results Overview
Change in subjective alcohol craving as measured by a Visual Analogue Scale (VAS) between time point 3 (before the alcohol cue) and 4 (after the alcohol cue). Participants completed the VAS at 8 timepoints: Minute 0 (pre-OT/placebo) (Time 1) Minute 5 (pre-OT/placebo) (Time 2) OT/placebo administered at minute 10 Minute 40 (Time 3) Minute 45 - alcohol cue paradigm began Time 4 (immediately after alcohol cue) Minute 65 - TAP began Time 5 (immediately after TAP began) Time 6 (15 minutes after TAP) Time 7 (30 minutes after TAP) Time 8 (60 minutes after TAP) This 100mm Visual Analogue Scale (VAS) was anchored on a 100mm Likert-type scale from 0 (not at all/no craving) to 10 (extremely/maximum carving). The scale is set to 100mm in length, and the lowest value is a 0 (zero), representing no craving and and highest value is a 10 (ten) representing extreme craving.
COMPLETED
PHASE2
200 participants
Participants completed the VAS at 8 timepoints. Outcome measure represents the change in VAS scores between time point 3 (before the alcohol cue) and 4 (after the alcohol cue).
2022-05-09
Participant Flow
Participants were enrolled from July 2017 through April 2021. Participants were recruited from local clinics, by using social media advertisements, and from the investigator's previous trials.
One hundred couples (N = 200 individuals) were enrolled using 1:1 randomization. Both partners within a couple were assigned to the same condition (oxytocin or placebo). Inclusion criteria indicated that one or both partners in each couple met DSM-5 criteria for current AUD and endorsed physical intimate partner aggression (IPA i.e., hitting, slapping) that occurred at any point during their current relationship, as assessed by the Revised Conflict Tactics Scale.
Participant milestones
| Measure |
Oxytocin
Each participant will self-administer 40 IU intranasal Oxytocin
Oxytocin: 40 IU oxytocin nasal spray
|
Control
Each participant will self-administer matching saline placebo
Placebo: Saline
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxytocin, Alcohol Craving, and Intimate Partner Aggression
Baseline characteristics by cohort
| Measure |
Oxytocin
n=100 Participants
Each participant will self-administer 40 IU intranasal Oxytocin
Oxytocin: 40 IU oxytocin nasal spray
|
Control
n=100 Participants
Each participant will self-administer matching saline placebo
Placebo: Saline
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
34.6 years
STANDARD_DEVIATION 11 • n=7 Participants
|
35.4 years
STANDARD_DEVIATION 113 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
64 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Relationship Status
Cohabitating
|
47 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Relationship Status
Married
|
39 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Relationship Status
Dating
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Relationship Status
Single
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Relationship Status
Separated
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Relationship Status
Divorced
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Relationship Status
Missing
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Alcohol Use Disorder (AUD)
Mild
|
30 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Alcohol Use Disorder (AUD)
Moderate
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Alcohol Use Disorder (AUD)
Severe
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Alcohol Use Disorder (AUD)
No AUD
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants completed the VAS at 8 timepoints. Outcome measure represents the change in VAS scores between time point 3 (before the alcohol cue) and 4 (after the alcohol cue).Change in subjective alcohol craving as measured by a Visual Analogue Scale (VAS) between time point 3 (before the alcohol cue) and 4 (after the alcohol cue). Participants completed the VAS at 8 timepoints: Minute 0 (pre-OT/placebo) (Time 1) Minute 5 (pre-OT/placebo) (Time 2) OT/placebo administered at minute 10 Minute 40 (Time 3) Minute 45 - alcohol cue paradigm began Time 4 (immediately after alcohol cue) Minute 65 - TAP began Time 5 (immediately after TAP began) Time 6 (15 minutes after TAP) Time 7 (30 minutes after TAP) Time 8 (60 minutes after TAP) This 100mm Visual Analogue Scale (VAS) was anchored on a 100mm Likert-type scale from 0 (not at all/no craving) to 10 (extremely/maximum carving). The scale is set to 100mm in length, and the lowest value is a 0 (zero), representing no craving and and highest value is a 10 (ten) representing extreme craving.
Outcome measures
| Measure |
Oxytocin
n=100 Participants
Each participant will self-administer 40 IU intranasal Oxytocin (OT)
Oxytocin: 40 IU oxytocin nasal spray
|
Control
n=100 Participants
Each participant will self-administer matching saline placebo
Placebo: Saline
|
|---|---|---|
|
Change in Alcohol Craving
|
0.90 score on a scale
Standard Error 0.12
|
1.21 score on a scale
Standard Error 0.12
|
PRIMARY outcome
Timeframe: 10 minutes from start to end of TAPIntensity of laboratory-based IPA was assessed using the Taylor Aggression Paradigm (TAP). IPA intensity is operationalized as the volume of "shock" administered on a 1-10 (1 is least intense, 10 is most intense) scale using the computer based paradigm in response to "losing" trials. TAP is a fictitious reaction time competition among partners. Participants are told that a winning trial required them to deliver a shock to their partner that ranged from 1 to 10 intensity for a duration of their choosing. A losing trial resulted in them receiving a shock from their partner (administered through two electrodes attached to the index and middle fingers of the nondominant hand). In reality, all participants received an identical sequence of "winning" or "losing" trials (and corresponding shocks) generated by the TAP software. IPA was operationalized as the average intensity (volume) and duration of shocks administered in response to "losing" trials.
Outcome measures
| Measure |
Oxytocin
n=100 Participants
Each participant will self-administer 40 IU intranasal Oxytocin (OT)
Oxytocin: 40 IU oxytocin nasal spray
|
Control
n=100 Participants
Each participant will self-administer matching saline placebo
Placebo: Saline
|
|---|---|---|
|
Laboratory Intimate Partner Aggression Intensity (IPA)
|
4.8 units on a scale
Standard Deviation 2.2
|
4.3 units on a scale
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: 10 minutes from start to end of TAPLaboratory IPA Duration was measured by the length of time participants administered "shocks" in the Taylor Aggression Paradigm (TAP). Measured in milliseconds. Greater number of milliseconds represents a longer shock. TAP is a fictitious reaction time competition among partners. Participants are told that a winning trial required them to deliver a shock to their partner that ranged from 1 to 10 intensity for a duration of their choosing. A losing trial resulted in them receiving a shock from their partner (administered through two electrodes attached to the index and middle fingers of the nondominant hand). In reality, all participants received an identical sequence of "winning" or "losing" trials (and corresponding shocks) generated by the TAP software. IPA was operationalized as the average intensity (volume) and duration of shocks administered in response to "losing" trials.
Outcome measures
| Measure |
Oxytocin
n=100 Participants
Each participant will self-administer 40 IU intranasal Oxytocin (OT)
Oxytocin: 40 IU oxytocin nasal spray
|
Control
n=100 Participants
Each participant will self-administer matching saline placebo
Placebo: Saline
|
|---|---|---|
|
Laboratory Intimate Partner Aggression (IPA) Duration
|
405.5 milliseconds
Standard Deviation 113.2
|
414.4 milliseconds
Standard Deviation 117.0
|
SECONDARY outcome
Timeframe: Measured between Time 4 (before the laboratory aggression paradigm) and Time 5 (after the laboratory aggression paradigm).Change in salivary cortisol measured between Time 4 (before the laboratory aggression paradigm) and Time 5 (after the laboratory aggression paradigm). Participants completed the VAS at 8 timepoints: Minute 0 (pre-OT/placebo) (Time 1) Minute 5 (pre-OT/placebo) (Time 2) OT/placebo administered at minute 10 Minute 40 (Time 3) Minute 45 - alcohol cue paradigm began Time 4 (immediately after alcohol cue) Minute 65 - TAP began Time 5 (immediately after TAP began) Time 6 (15 minutes after TAP) Time 7 (30 minutes after TAP) Time 8 (60 minutes after TAP) Higher salivary cortisol is indicative of higher stress response and lower salivary cortisol is indicative of lower stress response.
Outcome measures
| Measure |
Oxytocin
n=100 Participants
Each participant will self-administer 40 IU intranasal Oxytocin (OT)
Oxytocin: 40 IU oxytocin nasal spray
|
Control
n=100 Participants
Each participant will self-administer matching saline placebo
Placebo: Saline
|
|---|---|---|
|
Change in Cortisol
|
0.11 ul/dL
Interval 0.09 to 0.13
|
0.11 ul/dL
Interval 0.09 to 0.12
|
SECONDARY outcome
Timeframe: Change is aggression measured between time point 4 (after the alcohol cue) and 5 (during Taylor Aggression Paradigm).Mean change in subjective aggression scores as measured by a Visual Analogue Scale (VAS) between time point 4 (after alcohol cue) and 5 (during Taylor Aggression Paradigm, TAP). Participants completed the VAS at 8 timepoints: Minute 0 (pre-OT/placebo) (Time 1) Minute 5 (pre-OT/placebo) (Time 2) OT/placebo administered at minute 10 Minute 40 (Time 3) Minute 45 - alcohol cue paradigm began Time 4 (immediately after alcohol cue) Minute 65 - TAP began Time 5 (immediately after TAP began) Time 6 (15 minutes after TAP) Time 7 (30 minutes after TAP) Time 8 (60 minutes after TAP) This 100mm Visual Analogue Scale (VAS) was anchored on a Likert-type scale from 0 (not at all/no aggression) to 10 (extremely/maximum aggression). The scale is set to 100mm in length, and the lowest value is a 0 (zero), representing no aggression and and highest value is a 10 (ten) representing extreme aggression.
Outcome measures
| Measure |
Oxytocin
n=100 Participants
Each participant will self-administer 40 IU intranasal Oxytocin (OT)
Oxytocin: 40 IU oxytocin nasal spray
|
Control
n=100 Participants
Each participant will self-administer matching saline placebo
Placebo: Saline
|
|---|---|---|
|
Change in Subjective Aggression
|
0.31 score on a scale
Standard Error 0.10
|
0.41 score on a scale
Standard Error 0.09
|
Adverse Events
Oxytocin
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxytocin
n=100 participants at risk
Each participant will self-administer 40 IU intranasal Oxytocin
Oxytocin: 40 IU oxytocin nasal spray
|
Control
n=100 participants at risk
Each participant will self-administer matching saline placebo
Placebo: Saline
|
|---|---|---|
|
Ear and labyrinth disorders
Lightheadedness
|
0.00%
0/100 • 1 month
|
2.0%
2/100 • Number of events 2 • 1 month
|
|
Reproductive system and breast disorders
Upper Respiratory Infection
|
0.00%
0/100 • 1 month
|
1.0%
1/100 • Number of events 1 • 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/100 • 1 month
|
1.0%
1/100 • Number of events 1 • 1 month
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/100 • 1 month
|
1.0%
1/100 • Number of events 2 • 1 month
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/100 • 1 month
|
1.0%
1/100 • Number of events 1 • 1 month
|
Additional Information
Stacey Sellers
Medical University of South Carolina - Institute of Psychiatry
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place