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

NCT ID: NCT02469259

Last Updated: 2019-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment

Subjects will receive either 20IU or 40IU intranasal oxytocin

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

Placebo

Subjects will receive intranasal saline spray

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Oxytocin

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Other Intervention Names

Syntocinon

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Joshua Woolley

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josh D Woolley, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

San Francisco Veterans Affairs Medical Center

San Francisco, California, United States

Countries

United States

Other Identifiers

15-16676

Identifier Type: -

Identifier Source: org_study_id