The Effects of Oxytocin on Startle Hyperreactivity in Patients With AUD and PTSD
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 1/31/2019 |
| Start Date: | February 2016 |
| End Date: | February 28, 2018 |
The Effects of Oxytocin on Social Ability, Alcohol Approach Bias, and Startle Hyperreactivity in Veterans With Alcohol Use Disorder and Post Traumatic Stress Disorder
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.
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.
Inclusion Criteria:
1. Ages 18 to 75 (inclusive)
2. Current DSM-V diagnosis of PTSD
3. Current (past month) DSM-V diagnosis of a moderate to severe Alcohol Use Disorder
Exclusion Criteria:
1. Current or lifetime psychotic disorders, such as schizophrenia or bipolar disorder
2. Dementia or other neuropsychiatric disorders involving cognitive deficits or active
symptoms impairing their ability to complete study tasks.
3. Subjects known to have clinically significant unstable medical conditions, including
but not limited to clinically significant renal disease.
4. Use of disulfiram, naltrexone, or acamprosate for alcohol use disorder in the past
week.
5. 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);
6. Subjects who are legally mandated to participate in an alcohol treatment program.
7. Subjects who have had a suicide attempt in the past 6 months or suicidal ideation in
the 90 days prior to enrollment.
8. Subjects with seizure disorders that require anticonvulsant medications
9. Positive urine pregnancy test, women meeting DSM-V criteria for premenstrual dysphoric
disorder or with diseases likely to influence hormonal or neuroendocrine status
10. Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol
hemihydrate)
11. Nasal obstruction, discharge, or bleeding
12. Taking testosterone or estrogen/progesterone supplement, or 5HT1a
agonists/antagonists, as these agents can alter oxytocin levels
We found this trial at
1
site
San Francisco, California 94121
Principal Investigator: Josh Woolley, MD/PhD
Phone: 415-221-4810
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