Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

NCT02742532 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: NMCSD Oxytocin
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Craving to Use Alcohol Rating (Visual Analog Scale)

  The Visual Analog Scale (VAS) is a horizontal line of fixed 100 mm length. The ends are defined as the extreme limits of the parameter from the left (least) to the right (most). Subjects mark the point on the line that represents their perception of the parameter. The score is determined by measuring in millimeters from the left end of the line to the point that the patient marks. The score range is 0-100, with higher scores indicating higher cravings.

  Change from baseline to post-drug at 20 minutes

Secondary Outcomes (1)

• Change in Stress Rating (Visual Analog Scale)

  Change from baseline to post-drug at 20 minutes

Study Arms (2)

Oxytocin

EXPERIMENTAL

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

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Oxytocin DRUG

Intranasal oxytocin 40 IU

Also known as: Syntocinon nasal spray

Oxytocin

Placebo DRUG

Intranasal saline solution

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jennifer Mitchell: lead
• United States Naval Medical Center, San Diego: collaborator
• United States Department of Defense: collaborator
• Congressionally Directed Medical Research Programs: collaborator
• Eisenhower Army Medical Center: collaborator

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92106, United States

Location

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic; Anxiety Disorders; Substance-Related Disorders

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jennifer Mitchell, PhD
• Organization: University of California, San Francisco

jennifer.mitchell@ucsf.edu

510-985-3921

Study Officials

• Mardi Smith, PhD

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: April 19, 2016
• Study Start: April 20, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)