Oxytocin to Enhance Integrated Treatment for AUD and PTSD

  • STATUS
    Recruiting
  • End date
    Jan 1, 2026
  • participants needed
    180
  • sponsor
    Medical University of South Carolina
Updated on 27 December 2021
anxiety
substance use
oxytocin
functional magnetic resonance imaging
mood disorder

Summary

The primary objective of the proposed Stage II study is to examine the efficacy of oxytocin (OT) as compared to placebo in reducing (1) alcohol use disorder (AUD) symptoms, and (2) post-traumatic stress disorder (PTSD) symptoms among Veterans receiving COPE therapy (Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure). To evaluate purported neurobiological mechanisms of change, we will employ functional magnetic resonance imaging (fMRI) at pre- and post-treatment.

Description

Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) frequently co-occur and are associated with significant morbidity, mortality, and health care expenditures. Military Veterans are at increased risk for co-occurring AUD and PTSD, with prevalence rates 2-4 times higher than the general population. Our group developed an integrated intervention entitled Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE). COPE incorporates empirically validated cognitive-behavioral techniques for AUD with Prolonged Exposure (PE) therapy for PTSD. Several randomized controlled trials among Veterans and civilians demonstrate efficacy of COPE in significantly reducing AUD and PTSD symptoms. Despite the positive findings, there remains substantial room for improving treatment outcomes and enhancing retention. Accumulating data suggest that the neuropeptide oxytocin (OT) is a promising candidate to enhance psychosocial interventions for co-occurring AUD and PTSD, as OT targets neurobiological and behavioral dysregulation common to both disorders. Preclinical and clinical studies demonstrate the ability of OT to ameliorate a variety of alcohol-related behaviors (e.g., craving, withdrawal symptoms, tolerance, ethanol self-administration), enhance fear extinction, and promote prosocial behaviors associated with successful psychosocial treatment outcomes. In a randomized controlled pilot study, our group found that OT administration prior to weekly Prolonged Exposure (PE) therapy sessions was safe, well-tolerated, and resulted in accelerated reduction in PTSD symptoms as compared to placebo. Although the empirical and theoretical support for augmenting psychosocial interventions such as COPE with OT is robust, no studies to date have examined this combined approach. The primary objective of the proposed Stage II study is to examine the efficacy of OT as compared to placebo in reducing (1) AUD symptoms, and (2) PTSD symptoms among Veterans (50% women) receiving COPE therapy. To accomplish this, we will employ a manualized, evidence-based, cognitive-behavioral intervention (COPE); a randomized, double-blind, placebo-controlled study design; and standardized, repeated dependent measures of clinical outcomes at multiple time points. In addition, to investigate neurobiological mechanisms of change, we will employ functional magnetic resonance imaging (fMRI) at pre-and post-treatment .

Details
Condition PTSD, Alcohol Use Disorder
Treatment Placebo, 40 IU Intranasal Oxytocin, Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure
Clinical Study IdentifierNCT04523922
SponsorMedical University of South Carolina
Last Modified on27 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female; U.S. military Veteran, any race or ethnicity; aged 18-70 years
Able to provide written informed consent
Meet DSM-5 diagnostic criteria for current moderate to severe alcohol use disorder
Meet DSM-5 diagnostic criteria for current PTSD as assessed by the CAPS-5
Participants may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria) or anxiety disorders. Concurrent substance use disorders (e.g., marijuana) are acceptable provided alcohol is the participant's primary substance of choice
Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation

Exclusion Criteria

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 participants will be referred clinically for services
Participants on psychotropic medications which have been initiated during the past 4 weeks
Acute alcohol withdrawal as indicated by CIWA-Ar scores >8\
Pregnancy or breastfeeding for women
For MRI scan component: history of seizures or severe head injury, implanted metal devices or other metal (e.g., shrapnel). These participants will be eligible to enroll in the clinical trial but will not be eligible to participate in the neuroimaging component of the study
Currently enrolled in behavioral treatment for AUD or PTSD
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