Trial · Interventional

CompletedPhase 4Results postedRegistry data

Intranasal Oxytocin and Social Cognition, Implicit Preferences and Craving in Alcohol Drinkers

NCTNCT01829516Other idOxytocin

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 32 participants (actual)
Sponsor: University of California, San Francisco · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: May 2013
Primary completion: May 2014
Completion: Nov 2014
First posted: 11 Apr 2013 (estimated)
Last update posted: 27 Jul 2016 (estimated)
Conditions: AOD Use, Abuse, and Dependence

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201320142015

Ph 4
Intranasal Oxytocin and Social Cognition, Implicit Preferences and Craving in Alcohol Drinkers
NCT01829516
May 2013 to Nov 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a randomized, placebo controlled, double blind crossover study of the effects of intranasal oxytocin on social cognition, implicit preferences and craving in moderate to heavy social alcohol drinkers.

Interventions

OxytocinDrug
PlaceboDrug

Arms2

Experimental
Oxytocin
50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin.
Placebo comparator
Placebo
50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo. NOTE: This is a cross-over design and subjects will participate in both arms.

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study.
Time frame · Measured just prior to and after each of the water and alcohol cues at visits 2 and 3.
Registry description
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.

Secondary outcomes(1)

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.
Time frame · Administered at visits 2 and 3
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Measured just prior to and after each of the water and alcohol cues at visits 2 and 3.

Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study.

Group	Value (units on a 7-pt Likert Scale)	Spread
Oxytocin	1.11	0.20
Placebo	0.69	0.17

Secondary and other outcome results(1)

Secondary outcomeMean· Administered at visits 2 and 3

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.

Group	Value (Mean percent correct responses)	Spread
Oxytocin	77.2	1.7
Placebo	76.4	1.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Oxytocin50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin. Oxytocin	–	0 / 32	0 / 32
Placebo50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo. NOTE: This is a cross-over design and subjects will participate in both arms. Placebo	–	0 / 32	0 / 32

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 50 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Subject is a volunteer between 18 and 50 years of age. * If female, subject is non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device \[IUD\], hormonal birth control, or barrier method). * Subject is able to read and speak English. * Subject is able and willing to provide written informed consent. * Subject is able to understand and follow the instructions of the investigator and understand all screening questionnaires. * Subject is in good health. Exclusion Criteria: * Positive urine drug screen (except marijuana). * Using cocaine, stimulants (other than nicotine and caffeine), amphetamines, hallucinogens, ecstasy, opiates, sedatives, pain pills, sleeping pills, or other psychoactive drugs within 2 weeks of the start of the study (except marijuana) OR more than 10 times in the last year (except marijuana). * Marijuana use more than 3 times/week. * Has a current dependence on, or addiction to any psychoactive drug (except nicotine or caffeine) including alcohol OR a recent history of substance abuse other than alcohol, tobacco or marijuana. * Clinically significant medical or psychiatric illness requiring treatment as determined by screening blood tests, medical history, and/or physical exam performed or reviewed by the study physician. * BAC level \> 0.05% at the beginning of screening visit (within margin of error of detection). * Has a neurological dysfunction or psychiatric disorder (confirm with study physician). * Has a history of brain trauma (confirm with study physician). * Has an allergy or intolerance to oxytocin. * Subject has received an investigational drug within 30 days of Screening Visit. * Subject is considered unsuitable for the study in the opinion of the investigator, nurse practitioner, or study physician for any other reason.

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