Oxytocin + COPE Therapy for Alcoholism and PTSD
(COPE+OT Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Medical University of South Carolina
Must be taking: Psychotropic medications
Must not be taking: Psychotropic medications
Disqualifiers: Psychotic, Bipolar, Suicidal, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
If you are taking psychotropic medications, you need to be on a stable dose for at least 4 weeks before starting the study. If your medications were started in the past 4 weeks, you may not be eligible to participate.
What data supports the effectiveness of the drug oxytocin combined with COPE therapy for treating alcoholism and PTSD?
Research suggests that oxytocin, when used with therapy, may help reduce stress and improve social behaviors in people with both PTSD and alcohol use disorder. Studies show oxytocin can reduce alcohol consumption and help manage stress, which are key issues in these conditions.
12345Is oxytocin safe for humans when used for PTSD and alcohol use disorder?
Research suggests that oxytocin, when used in humans for conditions like PTSD and alcohol use disorder, is generally safe. Studies have shown it can reduce stress responses and promote positive social behaviors, with no major safety concerns reported.
12346What makes the treatment with oxytocin and COPE therapy unique for PTSD and alcohol use disorder?
This treatment is unique because it combines intranasal oxytocin, a hormone known for promoting social bonding and reducing stress, with COPE therapy, which is a specialized psychotherapy for PTSD and substance use disorders. Oxytocin may enhance the effects of therapy by reducing alcohol cravings and stress responses, offering a novel approach for conditions that currently lack effective pharmacological treatments.
12345Eligibility Criteria
This trial is for U.S. military Veterans aged 18-70 with moderate to severe alcohol use disorder (AUD) and PTSD, who are stable on any psychotropic meds for at least 4 weeks. It's not for those with bipolar disorders, current suicidal thoughts, acute alcohol withdrawal, pregnant or breastfeeding women, or anyone currently in AUD or PTSD therapy.Inclusion Criteria
Able to provide written informed consent
I have been on a stable dose of my mental health medication for at least 4 weeks.
Meet DSM-5 diagnostic criteria for current moderate to severe alcohol use disorder
+3 more
Exclusion Criteria
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
I am not pregnant or breastfeeding.
I have a history of or currently have severe mental health issues.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 12 weekly sessions of COPE Therapy with either Oxytocin or placebo
12 weeks
12 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
3 visits (in-person)
Participant Groups
The study tests if oxytocin can help reduce symptoms of AUD and PTSD better than a placebo in Veterans undergoing COPE therapy. Participants will also undergo brain scans before and after treatment to see how the therapy works.
2Treatment groups
Experimental Treatment
Active Control
Group I: Oxytocin Treatment GroupExperimental Treatment2 Interventions
Participants will receive 12 weekly sessions of Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE Therapy), plus intranasal Oxytocin.
40-IU dose of Oxytocin self-administered 30 minutes prior to the start of each weekly COPE session.
Group II: Placebo GroupActive Control2 Interventions
Participants will receive 12 weekly sessions of Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE Therapy), plus placebo (intranasal saline spray).
Intranasal dose of saline spray self-administered 30 minutes prior to the start of each weekly COPE session.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
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Who Is Running the Clinical Trial?
Medical University of South CarolinaLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
References
Craving Moderates the Effects of Intranasal Oxytocin on Anger in Response to Social Stress Among Veterans With Co-Occurring Posttraumatic Stress Disorder and Alcohol Use Disorder. [2022]Posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) commonly co-occur among US military veterans. Oxytocin may have therapeutic value in treating both conditions. The potential for oxytocin to augment affective features common to PTSD and AUD, such as anger, is relevant to inform emerging treatments.
Augmenting Treatment for Posttraumatic Stress Disorder and Co-Occurring Conditions with Oxytocin. [2022]The goal of this manuscript is to review the extant literature examining the neurobiological and behavioral mechanisms underlying the potential utility of intranasal oxytocin as a novel pharmacologic intervention for the treatment of posttraumatic stress disorder (PTSD), and for the treatment of co-morbid PTSD and alcohol and substance use disorders.
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. [2023]A 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.
Effects of oxytocin on stress reactivity and craving in veterans with co-occurring PTSD and alcohol use disorder. [2020]Posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) are highly prevalent and commonly co-occur. The dual diagnosis of PTSD/AUD is associated with serious negative sequalae, and there are currently no effective pharmacological treatments for this comorbidity. Both PTSD and AUD are characterized by dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, which helps modulate stress reactivity. Oxytocin, a neuropeptide that attenuates HPA axis dysregulation, may be beneficial for individuals with co-occurring PTSD/AUD. Thus, the current study examined the effects of intranasal oxytocin (40 IU) as compared with placebo on stress reactivity (e.g., cortisol) as well as subjective alcohol craving in response to a laboratory stress task (Trier Social Stress Task). Participants were 67 male U.S. military veterans with current PTSD and AUD (oxytocin n = 32, placebo n = 35; overall mean age = 49.06 years). Baseline cortisol levels were examined as a moderator of outcome. The findings revealed that oxytocin marginally attenuated cortisol reactivity in response to the stress task. Furthermore, oxytocin's effect was moderated by baseline cortisol level, such that oxytocin mitigated cortisol reactivity to a greater extent among participants with higher, as compared with lower, baseline cortisol. Oxytocin did not reduce craving. Although preliminary, the findings are the first to examine oxytocin in co-occurring PTSD/AUD. The findings from this study contribute to the growing literature examining the potential utility of oxytocin among individuals with psychiatric disorders, such as PTSD and substance use disorders. (PsycINFO Database Record (c) 2019 APA, all rights reserved).
Effects of Oxytocin Administration on Cue-Induced Craving in Co-occurring Alcohol Use Disorder and PTSD: A Within-Participant Randomized Clinical Trial. [2022]Individuals with alcohol use disorder (AUD) are much more likely to meet criteria for posttraumatic stress disorder (PTSD) than the general population. Compared to AUD alone, those with comorbid AUD-PTSD experience worse outcomes. Prior literature suggests that oxytocin, a hypothalamic neuropeptide, may be effective in the treatment of both AUD and PTSD when administered intranasally, although specific mechanisms remain elusive.
Oxytocin Reduces Sensitized Stress-Induced Alcohol Relapse in a Model of Posttraumatic Stress Disorder and Alcohol Use Disorder Comorbidity. [2023]There is high comorbidity of posttraumatic stress disorder (PTSD) and alcohol use disorder with few effective treatment options. Animal models of PTSD have shown increases in alcohol drinking, but effects of stress history on subsequent vulnerability to alcohol relapse have not been examined. Here we present a mouse model of PTSD involving chronic multimodal stress exposure that resulted in long-lasting sensitization to stress-induced alcohol relapse, and this sensitized stress response was blocked by oxytocin (OT) administration.