Trial Outcomes & Findings for Intranasal Oxytocin and Social Cognition, Implicit Preferences and Craving in Alcohol Drinkers (NCT NCT01829516)
NCT ID: NCT01829516
Last Updated: 2016-07-27
Results Overview
Change in craving represented by the mean difference in Alcohol Urge Questionnaire (AUQ) craving scores between alcohol and water cues (e.g., a positive alcohol-water score indicates cue-induced craving) after administration of oxytocin vs. placebo during the 3-week study. Craving for alcohol was assessed prior to the water and alcohol cues and again after each stimulus presentation using the 8-item Alcohol Urge Questionnaire (AUQ) (Bohn et al., 1995), in which subjects indicate how much they agree or disagree with statements regarding their alcohol craving on a 7-point Likert scale. AUQ craving scores are calculated by averaging responses to the 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores and ranges from 1 to 7. Higher scores reflect greater craving.
COMPLETED
PHASE4
32 participants
Measured just prior to and after each of the water and alcohol cues at visits 2 and 3.
2016-07-27
Participant Flow
Sixty-one nontreatment-seeking subjects were recruited online. Eligible subjects met DSM-IV criteria for alcohol abuse, but were excluded if physically dependent on alcohol. These subjects were screened to yield 39 eligible subjects. Of the 39 subjects deemed eligible, 7 did not return after the screening visit, resulting in 32 enrolled subjects.
Participant milestones
| Measure |
Oxytocin First, Then Placebo
18 moderate to heavy social alcohol users received a single dose 40 IU of intranasal oxytocin followed by a single dose 40 IU of intranasal placebo.
NOTE: This is a cross-over design and subjects will participate in both arms.
|
Placebo First Then Oxytocin
14 moderate to heavy social alcohol users received a single dose 40 IU of intranasal placebo followed by a single dose 40 IU of intranasal oxytocin.
NOTE: This is a cross-over design and subjects will participate in both arms.
|
|---|---|---|
|
First Intervention
STARTED
|
18
|
14
|
|
First Intervention
COMPLETED
|
18
|
14
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period - 1 Week
STARTED
|
18
|
14
|
|
Washout Period - 1 Week
COMPLETED
|
18
|
14
|
|
Washout Period - 1 Week
NOT COMPLETED
|
0
|
0
|
|
2nd Intervention
STARTED
|
18
|
14
|
|
2nd Intervention
COMPLETED
|
18
|
14
|
|
2nd Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intranasal Oxytocin and Social Cognition, Implicit Preferences and Craving in Alcohol Drinkers
Baseline characteristics by cohort
| Measure |
All Study Participants
n=39 Participants
This is a crossover study of 39 moderate to heavy social alcohol users who will receive a single dose 40 IU of intranasal oxytocin followed by 40 IU of placebo or vice versa.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Measured just prior to and after each of the water and alcohol cues at visits 2 and 3.Population: In this crossover study a total of 32 participants were analyzed for each intervention.
Change in craving represented by the mean difference in Alcohol Urge Questionnaire (AUQ) craving scores between alcohol and water cues (e.g., a positive alcohol-water score indicates cue-induced craving) after administration of oxytocin vs. placebo during the 3-week study. Craving for alcohol was assessed prior to the water and alcohol cues and again after each stimulus presentation using the 8-item Alcohol Urge Questionnaire (AUQ) (Bohn et al., 1995), in which subjects indicate how much they agree or disagree with statements regarding their alcohol craving on a 7-point Likert scale. AUQ craving scores are calculated by averaging responses to the 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores and ranges from 1 to 7. Higher scores reflect greater craving.
Outcome measures
| Measure |
Oxytocin
n=32 Participants
18 moderate to heavy social alcohol users received 40 IU of intranasal oxytocin followed by 40 IU of intranasal placebo and 14 received 40 IU of intranasal placebo first followed by 40 IU of intranasal oxytocin, for a total of 32 participants analyzed.
|
Placebo
n=32 Participants
14 moderate to heavy social alcohol users received 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin and 18 received 40 IU of intranasal oxytocin first followed by 40 IU of intranasal placebo, for a total of 32 participants analyzed.
|
|---|---|---|
|
Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study.
|
1.11 units on a 7-pt Likert Scale
Standard Error 0.20
|
0.69 units on a 7-pt Likert Scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Administered at visits 2 and 3Population: 1 subject did not complete the RMET task, so only 31 participant responses were analyzed for this task.
We will examine the effects of intranasal oxytocin administration on overall RMET performance in moderate to heavy social alcohol drinkers after placebo or oxytocin administration. The RMET has 28 items. Each item is an cropped photo of a person's eyes with four emotion labels around it. The subjects are asked to select which one of the four emotion words best describes the emotion that the eyes are showing. RMET is scored by adding up the total number of correct responses (range 0-28). The mean percent correct is then calculated.
Outcome measures
| Measure |
Oxytocin
n=31 Participants
18 moderate to heavy social alcohol users received 40 IU of intranasal oxytocin followed by 40 IU of intranasal placebo and 14 received 40 IU of intranasal placebo first followed by 40 IU of intranasal oxytocin, for a total of 32 participants analyzed.
|
Placebo
n=31 Participants
14 moderate to heavy social alcohol users received 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin and 18 received 40 IU of intranasal oxytocin first followed by 40 IU of intranasal placebo, for a total of 32 participants analyzed.
|
|---|---|---|
|
Average Percentage of Correct Responses on a Social Perception Task, Reading the Mind in the Eyes Test (RMET) After Administration of Oxytocin vs. Placebo During the 3-week Study.
|
77.2 Mean percent correct responses
Standard Error 1.7
|
76.4 Mean percent correct responses
Standard Error 1.5
|
Adverse Events
Oxytocin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jennifer Mitchell, PhD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place