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

NCT02469259 | Completed Early Phase 1

• 1 other identifier: 15-16676
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic; Alcoholism

Keywords

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

Outcome Measures

Primary Outcomes (9)

• 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.

• 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.

Study Arms (2)

Treatment

EXPERIMENTAL

Subjects will receive either 20IU or 40IU intranasal oxytocin

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Subjects will receive intranasal saline spray

Other: Placebo

Interventions

Oxytocin DRUG

Also known as: Syntocinon

Treatment

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Alcoholism

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Josh D Woolley, MD/PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 11, 2015
• Study Start: February 1, 2016
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

US (1)