Clinical trial NCT03865615: Oxytocin on Approach Bias and Craving
Official title: The Effects of Intranasal Oxytocin on Approach Bias and Craving in Moderate to Heavy Alcohol Drinkers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Alcohol Use Disorder
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within-subject, randomized, placebo-controlled, counterbalanced, crossover design.
Primary purpose: TREATMENT

Brief summary: This will be a laboratory-based investigation of the behavioral and neural effects of intranasal oxytocin on craving for alcohol and approach bias in moderate to heavy alcohol using subjects. This study uses a within-subject, randomized, placebo-controlled, counterbalanced, crossover design to compare the effects oxytocin and placebo. In this way, all subjects will be scanned twice; once following oxytocin administration and once following placebo administration, and will complete a series of behavioral tasks (both in and out of the scanner) at both visits.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers who are 21-40 years of age
* If female, 10 or more alcoholic drinks must be consumed weekly.
* If male, 14 or more alcoholic drinks must be consumed weekly.
* Meets DSM-V criteria for Alcohol Use Disorder (AUD).
* Score 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT)
* If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device \[IUD\], hormonal birth control, or barrier method).
* Native English speaker
* Right handed
* High school graduate or equivalent.
* Able and willing to provide an informed consent.
* Able to understand and follow the instructions of the investigator

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).
* Marijuana use more than 3 times/week.
* Current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use.
* Currently trying to quit alcohol use.
* History of major alcohol related complications within the preceding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, etc.).
* Has a history of atrophic rhinitis, recurrent nose bleeds, cranial surgical procedures, hypophysectomy, chronic congestion, or sinus problems.
* Has a history of cardiac arrhythmia.
* 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.
* Severely low blood (\< 90/50) pressure or uncontrolled high blood pressure (\>160/100).
* SGPT/ALT or SGOT/AST values greater than 2x upper limit of normal.
* BAC level \> 0.00% 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.
* Has received an investigational drug within 30 days of Screening Visit.
* Has any MRI scanning contraindications.
* Has a history of claustrophobia.

Primary outcomes:
measure: Alcohol cue craving score
timeFrame: ~ 90 minutes post study drug administration
measure: Image approach task
timeFrame: ~ 90 minutes post study drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jennifer Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References: