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Completed

NCT Number: NCT02469259

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

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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Key information

Conditions

Stress Disorders, Post-Traumatic Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Stress Disorders, Traumatic Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 18 to 75 (inclusive)
  • Current DSM-V diagnosis of PTSD
  • Current (past month) DSM-V diagnosis of a moderate to severe Alcohol Use Disorder

Exclusion criteria

  • Current or lifetime psychotic disorders, such as schizophrenia or bipolar disorder
  • Dementia or other neuropsychiatric disorders involving cognitive deficits or active symptoms impairing their ability to complete study tasks.
  • Subjects known to have clinically significant unstable medical conditions, including but not limited to clinically significant renal disease.
  • Use of disulfiram, naltrexone, or acamprosate for alcohol use disorder in the past week.
  • 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);
  • Subjects who are legally mandated to participate in an alcohol treatment program.
  • Subjects who have had a suicide attempt in the past 6 months or suicidal ideation in the 90 days prior to enrollment.
  • Subjects with seizure disorders that require anticonvulsant medications
  • Positive urine pregnancy test, women meeting DSM-V criteria for premenstrual dysphoric disorder or with diseases likely to influence hormonal or neuroendocrine status
  • Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol hemihydrate)
  • Nasal obstruction, discharge, or bleeding
  • Taking testosterone or estrogen/progesterone supplement, or 5HT1a agonists/antagonists, as these agents can alter oxytocin levels

Treatment and study plan

Oxytocin

Drug

Other names: Syntocinon

Placebo

Other

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study 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

Acronym: POP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 11, 2015
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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