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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Subjects will receive either 20IU or 40IU intranasal oxytocin |
|
| Placebo | Placebo Comparator | Subjects will receive intranasal saline spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Social Perception measured by score on the Reading the Eyes in the Mind Test | Participants will complete the task 60 minutes following test drug administration. This will occur 3 times during the study period, with each visit separated by at least 7 days. The total study duration will be an average of 4 weeks per subject. | |
| Alcohol Approach Bias measured by score on the Approach Avoidance Task | Participants will complete the task 65 minutes following test drug administration. This will occur 3 times during the study period, with each visit separated by at least 7 days. The total study duration will be an average of 4 weeks per subject. | |
| Startle Hyperactivity measured by heart rate change score in response to startle stimuli | Participants will complete the task 70 minutes following test drug administration. This will occur 3 times during the study period, with each visit separated by at least 7 days. The total study duration will be an average of 4 weeks per subject. | |
| Craving will measured by heart rate change score in response to a Cue-Induced Craving task | Participants will complete the task 80 minutes following test drug administration. This will occur 3 times during the study period, with each visit separated by at least 7 days. The total study duration will be an average of 4 weeks per subject. | |
| Craving will measured by skin conductance change score in response to a Cue-Induced Craving task | Participants will complete the task 80 minutes following test drug administration. This will occur 3 times during the study period, with each visit separated by at least 7 days. The total study duration will be an average of 4 weeks per subject. | |
| Theory of Mind will me measured by score on the Theory of Mind Geometric Task | Participants will complete the task 90 minutes following test drug administration. This will occur 3 times during the study period, with each visit separated by at least 7 days. The total study duration will be an average of 4 weeks per subject. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josh D Woolley, MD/PhD | University of California San Francisco, San Francisco Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Veterans Affairs Medical Center | San Francisco | California | 94121 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Other |
|
| Social Threat Processing will be measured by score on the Social Dot Probe Task | Participants will complete the task 100 minutes following test drug administration. This will occur 3 times during the study period, with each visit separated by at least 7 days. The total study duration will be an average of 4 weeks per subject. |
| Social Cognition will be measured by score on the Facemorph Task. | Participants will complete the task 105 minutes following test drug administration. This will occur 3 times during the study period, with each visit separated by at least 7 days. The total study duration will be an average of 4 weeks per subject. |
| Working Memory will be measured by score on the Symmetry Span Task | Participants will complete the task 120 minutes following test drug administration. This will occur 3 times during the study period, with each visit separated by at least 7 days. The total study duration will be an average of 4 weeks per subject. |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |