Alcohol Use Disorder
Conditions
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.
Interventions
DRUGOxytocin
intranasal oxytocin 40IU/mL
DRUGPlacebo
Placebo
Sponsors
Jennifer Mitchell
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Within-subject, randomized, placebo-controlled, counterbalanced, crossover design.
Eligibility
Sex/Gender
ALL
Age
21 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol cue craving score | ~ 90 minutes post study drug administration | Subjects will be asked to perform a standardized alcohol cue exposure paradigm and be asked to rate their subjective craving following alcohol cue presentation using a standard visual analog scale. Craving scores (ranging from 1-10 on VAS) will be compared across both the active study drug and placebo. |
| Image approach task | ~ 90 minutes post study drug administration | Subjects will be asked to perform an image approach task where subjects are presented with a series of images and asked to pull or push a joystick following each presentation. Response direction and speed are recorded and compared across both the active study drug and placebo. |
Countries
United States
Outcome results
None listed