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Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

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ClinicalTrials.gov Identifier: NCT02058251
Recruitment Status : Completed
First Posted : February 10, 2014
Results First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE February 6, 2014
First Posted Date  ICMJE February 10, 2014
Results First Submitted Date  ICMJE April 27, 2018
Results First Posted Date  ICMJE March 14, 2019
Last Update Posted Date March 14, 2019
Study Start Date  ICMJE February 2014
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
Alcohol Craving [ Time Frame: 2 hours ]
Using the Visual Analogue Scale (VAS), participants provided self-report ratings of subjective alcohol cravings on a scale of 1-10, with one being the lowest/better score, and 10 being the highest/worst outcome.
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2014)
Alcohol Craving [ Time Frame: 2 hours ]
Participants will self-report ratings of subjective alcohol cravings.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
Stress Reactivity [ Time Frame: 2 hours ]
Salivary Cortisol (μg/dL). Greater cortisol levels are indicative of greater stress reactivity.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2014)
Stress Reactivity [ Time Frame: 2 hours ]
Participants will self-report subjective ratings of distress. Physiological measures (skin conductance, heart rate, salivary cortisol) will also be collected.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
Official Title  ICMJE Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
Brief Summary In comparison to the general population, military personnel and veterans are at increased risk of developing both substance use disorders (SUDs) and post-traumatic stress disorder (PTSD). Despite promising developments in the past decade, the treatment of patients with SUDs and comorbid PTSD is woefully inadequate (Back, 2010; Back et al., 2014; Brady et al., 2007; McCauley et al., 2012). One of the adverse effects of abused drugs is their long-term negative impact on social behavior that is thought to involve oxytocin (OT) dysregulation (McGregor et al., 2008). In preclinical and clinical experiments, local, intra-nasal, or systemic OT administration decreases activation of the amygdala in response to visual fearful/threatening stimuli (Kirsch et al., 2005), ameliorates the effects of stressful events, and decreases drug-taking and seeking behavior (McGregor et al., 2008; Baskerville and Douglas, 2010; Carson et al., 2010a; Bowen et al., 2011; Cox et al 2013). However, little attention has been focused on whether OT decreases SUD vulnerability after exposure to traumatic stress in preclinical or clinical studies. This clinical project will determine whether intra-nasally administered OT will decrease craving (Aim 1) to use alcohol and decrease stress reactivity (Aim 2) following exposure to laboratory-induced stress (Trier Social Stress Task) among veterans with a dual diagnosis of alcohol use disorder and PTSD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorders
Intervention  ICMJE
  • Drug: Oxytocin
    One 40 IU dose of intranasal oxytocin will be self-administered (5 puffs in each nostril) by participants.
  • Drug: Placebo
    Each participant will self-administer a 40 IU dose of intranasal saline.
Study Arms  ICMJE
  • Experimental: Oxytocin
    Each participant will self-administer a 40 IU dose of intranasal oxytocin.
    Intervention: Drug: Oxytocin
  • Placebo Comparator: Control
    Each participant will self-administer a 40 IU dose of intranasal saline.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2017)
73
Original Estimated Enrollment  ICMJE
 (submitted: February 7, 2014)
66
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female; any race or ethnicity; age 21-65 years.
  • Female subjects will be required to complete the laboratory testing during the early to mid-follicular phase of their menstrual cycle (days 1-7 following the onset of menses).
  • Veteran of the US military; any service branch.
  • Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments.
  • Subjects must be able to comprehend English.
  • Meet DSM-5 criteria for a current alcohol use disorder (assessed via the Mini International Neuropsychiatric Interview; MINI). Note that we will use the currently available diagnostic measure (MINI for DSM-IV) and will make appropriate modifications to update for compatibility with DSM-5.
  • Meet DSM-5 criteria for current PTSD (assessed via the Clinician Administered PTSD Scale; CAPS). Note that we will use the currently available assessment instrument (CAPS for DSM-IV), and will make appropriate modifications to update for compatibility with DSM-5.
  • A CAPS score of 50 or greater.
  • Subjects will be required to have at least 5 days of abstinence from alcohol or other substances (except caffeine or nicotine) prior to completing the laboratory testing, as verified by multiple methods including self-report, breathalyzer tests, and urine drug screen tests.
  • Subjects may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria) or anxiety disorders (e.g., agoraphobia, social phobia, generalized anxiety disorder). The inclusion of subjects with affective and anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with PTSD and alcohol use disorders.
  • Subjects taking psychotropic medications will be required to be maintained on a stable dose for at least eight weeks before study initiation. This is because initiation or change of psychotropic medications during the course of the trial may interfere with interpretation of results.
  • Must consent to random assignment to oxytocin or placebo.

Exclusion Criteria:

  • Subjects meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders, or with current suicidal or homicidal ideation and intent. Those subjects will be referred clinically.
  • Subjects who would present a serious suicide risk or who are likely to require hospitalization during the course of the study. Those subjects will be referred clinically.
  • Subjects on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 8 weeks.
  • 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 meeting DSM-5 criteria for another substance use disorder, except caffeine or nicotine, within the past 12 months.
  • Subjects experiencing withdrawal symptoms, as evidence by a score of 10 or above on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA)
  • Females who are unable or unwilling to be scheduled for lab testing during the early to mid-follicular phase of their menstrual cycle.
  • Pregnant women will be excluded from the proposed study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02058251
Other Study ID Numbers  ICMJE 018127-002 Seq. 1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sudie E. Back, Ph.D. Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP