Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

NCT ID: NCT02742532

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-20
• Study Completion Date: 2019-07-01

Brief Summary

The purpose of this study is to determine whether oxytocin will decrease craving to use drugs/alcohol and stress reactivity following exposure to laboratory-induced stress among Active Duty Service Members with a dual diagnosis of alcohol/substance use disorder (ASUD) and post-traumatic anxiety.

Detailed Description

The purpose of this study is to determine whether intra-nasally administered oxytocin will decrease craving to use alcohol and stress reactivity following exposure to laboratory-induced stress among Active Duty Service Members (AD SMs) with a dual diagnosis of alcohol/substance use disorder (ASUD) and post-traumatic anxiety (i.e., PTSD or anxiety disorder NOS).

This is a 2-arm placebo controlled study. Subjects will complete a battery of self-report questionnaires and behavioral interviews. Baseline assessments of subjective (craving, stress), physiologic (HR, BP), and neuroendocrine measures (salivary cortisol) will be collected. These same assessments will be repeatedly collected throughout the testing portion of the study. Subjects will receive acute administration of intra-nasal oxytocin or placebo and will then be exposed to a laboratory-induced social stressor. They will be asked to give a short speech and perform arithmetic in front of a panel of judges. Following the task, additional post-task assessments of the subjective, physiological, and neuroendocrine measures will be completed over the next hour.

Conditions

Alcohol Use Disorder; Stress Disorders, Post-Traumatic; Anxiety Disorders; Substance Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Oxytocin

Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

Intranasal oxytocin 40 IU

Placebo

Intra-nasal saline placebo (5 puffs in each nostril)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intranasal saline solution

Interventions

Oxytocin

Intranasal oxytocin 40 IU

Intervention Type: DRUG

Placebo

Intranasal saline solution

Intervention Type: DRUG

Other Intervention Names

Syntocinon nasal spray

Eligibility Criteria

Inclusion Criteria

• Active Duty Service Members, any service branch; age 18-65 years.
• Meets clinician assessment for current PTSD OR anxiety disorder NOS OR scores on DASS > 10 on Anxiety or > 19 on Stress.
• Meets clinician assessment for alcohol use disorder (AUD) OR scores >8 on AUDIT.
• If meet current or lifetime criteria for another substance disorder, must indicate that AUD is primary.
• Subjects taking psychotropic medications will be required to be maintained on a stable dose for at least two weeks before study initiation (unless at physician's discretion following psychological consult).
• Negative urine drug screen test and BAC =0.
• Able to comprehend English.
• Able to provide informed consent and function at an intellectual level sufficient to allow completion of the assessment instruments.
• Must consent to random assignment to oxytocin or placebo.

Exclusion Criteria

• Positive urine drug screen (except marijuana) or BAC > 0.
• Untreated subjects currently symptomatic of psychotic or bipolar affective disorders.
• Subjects with current suicidal or homicidal ideation and intent, who would present a serious suicide risk.
• Subjects on psychotropic drugs that have been initiated during the past 2 weeks (unless approved at physician's discretion following psychological consult).
• Subjects with a history of a major medical illness (e.g., endocrine, cardiovascular, central nervous system disorders, peripheral neuropathy, or pulmonary disease) or other acute or unstable medical condition that might interfere with safe conduct of the study or accurate interpretation of the results.
• Subjects experiencing withdrawal symptoms as reported by Clinician or systolic BP≥160 mmHg, diastolic BP ≥100 mmHg and resting HR ≥100 bpm.
• Subject is considered unsuitable for the study in the opinion of study PI or AIs for any other reason.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Naval Medical Center, San Diego

FED

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

Congressionally Directed Medical Research Programs

FED

Sponsor Role: collaborator

Eisenhower Army Medical Center

FED

Sponsor Role: collaborator

Jennifer Mitchell

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Mitchell

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mardi Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

United States Naval Medical Center, San Diego

Locations

Naval Medical Center San Diego

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NMCSD Oxytocin

Identifier Type: -

Identifier Source: org_study_id