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

NCT01829516 | Completed Phase 4 Results DMC

• 1 other identifier: Oxytocin
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

AOD Use, Abuse, and Dependence

Outcome Measures

Primary Outcomes (1)

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

  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.

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

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.

  Administered at visits 2 and 3

Study Arms (2)

Oxytocin

EXPERIMENTAL

50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin.

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Oxytocin DRUG

Intranasal oxytocin

Also known as: Syntocinon

Oxytocin

Placebo DRUG

Intranasal placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Ernest Gallo Clinic and Research Center

Emeryville, California, 94608, United States

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Jennifer Mitchell, PhD
• Organization: University of California, San Francisco

jennifer.mitchell@ucsf.edu

510-985-3921

Study Officials

• Josh Woolley, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 11, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: November 1, 2014
• Last Updated: July 27, 2016
• Results First Posted: June 27, 2016

Record last verified: 2016-06

Locations

US (1)