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The Effects of Oxytocin on Startle Hyperreactivity in Patients With AUD and PTSD (POP)

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ClinicalTrials.gov Identifier: NCT02469259
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua Woolley, University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Alcoholism Drug: Oxytocin Other: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Oxytocin on Social Ability, Alcohol Approach Bias, and Startle Hyperreactivity in Veterans With Alcohol Use Disorder and Post Traumatic Stress Disorder
Actual Study Start Date : February 2016
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Treatment
Subjects will receive either 20IU or 40IU intranasal oxytocin
Drug: Oxytocin
Other Name: Syntocinon

Placebo Comparator: Placebo
Subjects will receive intranasal saline spray
Other: Placebo



Primary Outcome Measures :
  1. Social Perception measured by score on the Reading the Eyes in the Mind Test [ Time Frame: 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. ]
  2. Alcohol Approach Bias measured by score on the Approach Avoidance Task [ Time Frame: 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. ]
  3. Startle Hyperactivity measured by heart rate change score in response to startle stimuli [ Time Frame: 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. ]
  4. Craving will measured by heart rate change score in response to a Cue-Induced Craving task [ Time Frame: 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. ]
  5. Craving will measured by skin conductance change score in response to a Cue-Induced Craving task [ Time Frame: 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. ]
  6. Theory of Mind will me measured by score on the Theory of Mind Geometric Task [ Time Frame: 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. ]
  7. Social Threat Processing will be measured by score on the Social Dot Probe Task [ Time Frame: 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. ]
  8. Social Cognition will be measured by score on the Facemorph Task. [ Time Frame: 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. ]
  9. Working Memory will be measured by score on the Symmetry Span Task [ Time Frame: 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469259


Locations
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United States, California
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Josh D Woolley, MD/PhD University of California San Francisco, San Francisco Veterans Affairs Medical Center
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Responsible Party: Joshua Woolley, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02469259    
Other Study ID Numbers: 15-16676
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Keywords provided by Joshua Woolley, University of California, San Francisco:
oxytocin
PTSD
Alcohol Use Disorder
social cognition
craving
fear-potentiated startle
Additional relevant MeSH terms:
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Alcoholism
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs