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

Primary Purpose

Stress Disorders, Post-Traumatic, Alcoholism

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Oxytocin

Placebo

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring oxytocin, PTSD, Alcohol Use Disorder, social cognition, craving, fear-potentiated startle

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

San Francisco Veterans Affairs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

Subjects will receive either 20IU or 40IU intranasal oxytocin

Subjects will receive intranasal saline spray

Outcomes

Primary Outcome Measures

Social Perception measured by score on the Reading the Eyes in the Mind Test

Alcohol Approach Bias measured by score on the Approach Avoidance Task

Startle Hyperactivity measured by heart rate change score in response to startle stimuli

Craving will measured by heart rate change score in response to a Cue-Induced Craving task

Craving will measured by skin conductance change score in response to a Cue-Induced Craving task

Theory of Mind will me measured by score on the Theory of Mind Geometric Task

Social Threat Processing will be measured by score on the Social Dot Probe Task

Social Cognition will be measured by score on the Facemorph Task.

Working Memory will be measured by score on the Symmetry Span Task

Secondary Outcome Measures

Full Information

NCT ID

NCT02469259

First Posted

June 9, 2015

Last Updated

May 17, 2019

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT02469259

Brief Title

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

Acronym

POP

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

February 2016 (Actual)

Primary Completion Date

February 28, 2018 (Actual)

Study Completion Date

February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Francisco

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Disorders, Post-Traumatic, Alcoholism

Keywords

oxytocin, PTSD, Alcohol Use Disorder, social cognition, craving, fear-potentiated startle

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Subjects will receive either 20IU or 40IU intranasal oxytocin

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects will receive intranasal saline spray

Intervention Type

Drug

Intervention Name(s)

Oxytocin

Other Intervention Name(s)

Syntocinon

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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.

Title

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.

Title

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.

Title

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.

Title

Craving will measured by skin conductance change score in response to a Cue-Induced Craving task

Time Frame

Title

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.

Title

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.

Title

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.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Josh D Woolley, MD/PhD

Organizational Affiliation

University of California San Francisco, San Francisco Veterans Affairs Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

San Francisco Veterans Affairs Medical Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94121

Country

United States

12. IPD Sharing Statement

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

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