Evidence map›Paper›PMID 36646315›Full record

ArticleContemporary clinical trials2023

COPE and oxytocin for the treatment of co-occurring PTSD and alcohol use disorder: Design and methodology of a randomized controlled trial in U.S. military veterans.

Sudie E Back, Julianne C Flanagan, Therese Killeen, Tanya C Saraiya, Delisa G Brown, Amber M Jarnecke, Alex O Rothbaum, Jane Joseph, Elizabeth Santa Ana, Abigail de Arellano and 4 more

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04523922 (Oxytocin to Enhance Integrated Exposure-Based Treatment of Co-occurring Alcohol Use Disorder and PTSD), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
2.3field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04523922 phase2completednot on this map

Oxytocin to Enhance Integrated Exposure-Based Treatment of Co-occurring Alcohol Use Disorder and PTSD

TypeinterventionalSponsorMedical University of South CarolinaRan2021 to 2026Enrolled175ConditionsPTSD, Alcohol Use DisorderArms40 IU Intranasal Oxytocin, Placebo, Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 2 institutions in 1 country.

Sudie E BackDepartment of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.
Julianne C FlanaganDepartment of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA.
Therese KilleenDepartment of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.
Tanya C SaraiyaDepartment of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.
Delisa G BrownDepartment of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.
Amber M JarneckeDepartment of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.
Alex O RothbaumDepartment of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.
Jane JosephDepartment of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.
Elizabeth Santa AnaDepartment of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA.
Abigail de ArellanoDepartment of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.
Hannah L ShoemakerDepartment of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.
Reagan Ashley DixonDepartment of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.
Paul J NietertDepartment of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.
Kathleen T BradyDepartment of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.
Medical University of South Carolina · USRalph H. Johnson VA Medical Center · US

Funding

The Impact of Stress and Craving on Return to Postpartum Cannabis UseU54DA016511 · NIDA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI CONSTANCE GUILLE · 2018 to 2026
$15.9M
Vocational Training for Drug Dependent WomenP50DA016511 · NIDA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2002 to 2017
$14.5M
SOUTH CAROLINA CLINICAL & TRANSLATIONAL RESEARCH INSTITUTE (SCTR)UL1RR029882 · NCRR · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2009 to 2011
$10.1M
Traumatic Stress Across the Lifespan: A Biopsychosocial Training ProgramT32MH018869 · NIMH · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI CARLA KMETT DANIELSON, DEAN Gaines KILPATRICK · 1988 to 2026
$7.2M
Translational Research Training on Addictions for Racial/Ethnic MinoritiesR25DA035161 · NIDA · CITY COLLEGE OF NEW YORK · PI DENISE AIMEE HIEN, Lesia Monique Ruglass · 2013 to 2026
$4.4M
Oxytocin to Enhance Integrated Exposure-Based Treatment of Co-occurring Alcohol Use Disorder and PTSDR01AA028811 · NIAAA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BACK, SUDIE E, FLANAGAN, JULIANNE CHRISTINA · 2020 to 2024
$3.3M
Randomized Controlled Trial of N-acetylcysteine for Alcohol Use Disorder and Comorbid PTSDR01AA025086 · NIAAA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BACK, SUDIE E, GRAY, KEVIN M · 2016 to 2020
$3.1M
Integrated Treatment for Co-Occurring Opioid Use Disorder and Posttraumatic Stress DisorderK23DA055209 · NIDA · RUTGERS, THE STATE UNIV OF N.J. · PI Tanya Chandresh Saraiya · 2022 to 2026
$1.1M
Identifying the neurobehavioral signature of individuals with AUD and comorbid PTSDK23AA027307 · NIAAA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI JARNECKE, AMBER · 2019 to 2023
$1.0M
Integrating Neurobiology and Neuroimaging into Research on Addiction and PTSDK02DA039229 · NIDA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BACK, SUDIE E · 2015 to 2019
$779k
Effects of Oxytocin on Alcohol Craving and Intimate Partner AggressionK23AA023845 · NIAAA · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI FLANAGAN, JULIANNE CHRISTINA · 2016 to 2019
$774k
NCRR NIH HHS UL1 RR029882NIAAA NIH HHS K23 AA023845NIAAA NIH HHS K23 AA027307NIAAA NIH HHS R01 AA025086NIAAA NIH HHS R01 AA028811NIDA NIH HHS K02 DA039229NIDA NIH HHS K23 DA055209NIDA NIH HHS P50 DA016511NIDA NIH HHS R25 DA035161NIDA NIH HHS U54 DA016511NIMH NIH HHS T32 MH018869
6 · The paper itself

Abstract

backgroundA significant proportion of individuals with alcohol use disorder (AUD) also meet criteria for posttraumatic stress disorder (PTSD). Military veterans are at increased risk for developing co-occurring AUD/PTSD, with prevalence rates 2-4 times higher than the general population. Research is needed to develop more effective treatments for this common comorbidity. The current investigation addresses this need by examining the synergistic effects of a novel pharmacotherapy combined with psychotherapy for co-occurring AUD/PTSD among veterans. Accumulating evidence suggests that the neuropeptide oxytocin (OT) is a promising pharmacotherapy to augment psychotherapy for AUD/PTSD. OT targets neurobiological and behavioral dysregulation common to both AUD and PTSD, in particular, corticolimbic connectivity. Human and animal studies show OT reduces alcohol self-administration, tolerance, and withdrawal; enhances fear extinction; and promotes prosocial behaviors. The current study builds on previous work by examining OT among veterans with AUD/PTSD receiving Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE), an evidence-based integrated treatment.

methodsThis paper describes the rationale, design, and methodology of a Stage II, 12-week, double-blind, randomized clinical trial of intranasal OT (40 IU) versus placebo combined with COPE among veterans (N = 180) with current AUD/PTSD. In addition, the effects of treatment on corticolimbic connectivity will be examined using functional magnetic resonance imaging (fMRI) at pre- and post-treatment.

conclusionsThe proposed study will provide new knowledge and mechanistic insights to accelerate research in this understudied area and may lead to improved treatment outcomes for co-occurring AUD/PTSD. CLINICALTRIALS: gov: NCT04523922.

Indexed as

AlcoholismStress Disorders, Post-TraumaticVeteransExtinction, PsychologicalFearHumansOxytocinRandomized Controlled Trials as TopicOxytocinAlcoholCOPEOxytocinPosttraumatic stress disorderPTSDVeterans

Identifiers

PMID36646315
PMCPMC9998357
OpenAlexW4315884137

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.