Clinical Trials Directory

Trials / Completed

CompletedNCT02742532

Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
63 (actual)
Sponsor
Jennifer Mitchell · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGOxytocinIntranasal oxytocin 40 IU
DRUGPlaceboIntranasal saline solution

Timeline

Start date
2017-04-20
Primary completion
2019-07-01
Completion
2019-07-01
First posted
2016-04-19
Last updated
2020-10-19
Results posted
2020-10-19

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT02742532. Inclusion in this directory is not an endorsement.