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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

Overview

Status
Completed
Phase
Phase 2
Enrollment
63 participants (actual)
Sponsor
Jennifer Mitchell · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
20 Apr 2017
Primary completion
1 Jul 2019
Completion
1 Jul 2019
First posted
19 Apr 2016 (estimated)
Last update posted
19 Oct 2020
Conditions
Alcohol Use Disorder · Stress Disorders, Post-Traumatic · Anxiety Disorders · Substance Use Disorders

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020
  1. Ph 2

    Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

    NCT02742532

    20 Apr 2017 to 1 Jul 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • PlaceboDrug

Arms2

  • Experimental

    Oxytocin

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

  • Placebo comparator

    Placebo

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Change from baseline to post-drug at 20 minutes

    Registry description

    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.

Secondary outcomes(1)
  1. Change in Stress Rating (Visual Analog Scale)

    Time frame · Change from baseline to post-drug at 20 minutes

    Registry description

    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 stress.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Change from baseline to post-drug at 20 minutes

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

GroupValue (score on a scale)Spread
Oxytocin0.0761.77
Placebo-0.9281.42
Secondary and other outcome results(1)
Secondary outcomeMean· Change from baseline to post-drug at 20 minutes

Change in Stress Rating (Visual Analog Scale)

GroupValue (score on a scale)Spread
Oxytocin-0.7551.24
Placebo-1.2681.82

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
OxytocinIntra-nasal oxytocin (40 IUs; 5 puffs in each nostril) Oxytocin: Intranasal oxytocin 40 IU0 / 310 / 310 / 31
PlaceboIntra-nasal saline placebo (5 puffs in each nostril) Placebo: Intranasal saline solution0 / 320 / 320 / 32

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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