This study will investigate the effects of oxytocin on alcohol-related behaviors, social
abilities, and physiological startle responses in healthy individuals and patients with
posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) using a randomized,
placebo-controlled, dose-tiered, between-subject study design. Specifically, the
investigators will determine if intranasal administration of a single dose of the pro-social
neuropeptide oxytocin decreases alcohol-related approach bias and cravings, enhances social
abilities, and decreases physiological hyperactivity. The investigators will also determine
the optimal dose to achieve these effects and will explore psychosocial predictors of
responses to oxytocin. The proposed work has the potential to yield a novel pharmacological
treatment for AUD and PTSD, both leading causes of disability in the US Military for which
currently available treatments are inadequate.
1. Ages 18 to 55 (inclusive)
2. Current DSM-V diagnosis of PTSD
3. Current (past month) DSM-V diagnosis of a moderate to severe Alcohol Use Disorder
1. Psychotic disorders, such as bipolar disorder, dementia, or other psychiatric
disorders judged to be unstable.
2. Subjects known to have clinically significant unstable medical conditions, including
but not limited to clinically significant renal disease and/or impaired renal
function as defined by clinically significant elevation of blood urea nitrogen (BUN)
or creatinine or an estimated creatinine clearance of < 60 mL/min, AST and/or ALT >5
times the upper limit of the normal range and/or an increased serum bilirubin >2
times the upper limit of normal.
3. Current medications for alcohol dependence (disulfiram, naltrexone, or acamprosate)
or use in the past week.
4. Needing acute medical detoxification from alcohol based on a score of 12 or more on
the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-AD);
5. Subjects who are legally mandated to participate in an alcohol treatment program.
6. Subjects who have had a suicide attempt in the past 6 months or suicidal ideation in
the 90 days prior to enrollment.
7. Subjects with seizure disorders that require anticonvulsant medications
8. Positive urine pregnancy test, women meeting DSM-V criteria for premenstrual
dysphoric disorder or with diseases likely to influence hormonal or neuroendocrine
9. Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol
10. Nasal obstruction, discharge, or bleeding
11. Taking antipsychotics or mood stabilizers, testosterone or estrogen/progesterone
supplement, or 5HT1a agonists/antagonists, as these agents can alter oxytocin levels
Josh D Woolley, MD/PhD
University of California San Francisco, San Francisco Veterans Affairs Medical Center
Lily Dobberteen, BA
Phone: 415-221-4810 ext. 25106