Oxytocin + COPE Therapy for Alcoholism and PTSD

(COPE+OT Trial)

Overseen By Sudie Back, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

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 All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 12 weeks

180 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 4 6}

What 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. ^{1 2 3 4 5}

Research Team

Sudie Back, PhD

Principal Investigator

Medical University of South Carolina

Eligibility 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

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.

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)

Treatment Details

Interventions

• Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure
• Intranasal Oxytocin
• Placebo

Trial Overview 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.

Participant Groups

Group I: Oxytocin Treatment Group Experimental Treatment 2 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 Group Active Control 2 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.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

In a study of 73 veterans with both PTSD and alcohol use disorder, intranasal oxytocin was found to significantly reduce post-stress task anger in individuals with low alcohol craving, suggesting its potential therapeutic value.

However, the effectiveness of oxytocin in reducing anger was less pronounced in those with high alcohol craving, indicating that individual differences in craving levels should be considered when evaluating oxytocin as a treatment for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Melkonian, AJ., Flanagan, JC., Calhoun, CD., et al.[2022]

Intranasal oxytocin is a promising, low-cost treatment option for posttraumatic stress disorder (PTSD) with a strong safety profile, especially when combined with established psychotherapy methods.

Current research suggests that while oxytocin may enhance treatment outcomes for PTSD and related substance use disorders, further studies are needed to understand its mechanisms of action and optimize delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmenting Treatment for Posttraumatic Stress Disorder and Co-Occurring Conditions with Oxytocin. Flanagan, JC., Mitchell, JM.[2022]

The study investigates the effects of intranasal oxytocin combined with psychotherapy (COPE) in treating veterans with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD), involving 180 participants over a 12-week period.

Oxytocin is believed to enhance treatment by targeting neurobiological issues common to both AUD and PTSD, potentially improving treatment outcomes and understanding the underlying brain mechanisms through fMRI assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Back, SE., Flanagan, JC., Killeen, T., et al.[2023]

In a study involving 67 male U.S. military veterans with PTSD and alcohol use disorder, intranasal oxytocin (40 IU) was found to marginally reduce cortisol reactivity to stress, particularly in those with higher baseline cortisol levels.

However, oxytocin did not significantly decrease alcohol craving, indicating that while it may help with stress response, it may not address all symptoms associated with the dual diagnosis of PTSD and alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of oxytocin on stress reactivity and craving in veterans with co-occurring PTSD and alcohol use disorder. Flanagan, JC., Allan, NP., Calhoun, CD., et al.[2020]

In a study involving 47 male patients with both alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD), intranasal oxytocin did not reduce self-reported alcohol craving or heart rate responses to alcohol cues compared to a placebo.

These results suggest that oxytocin may not be effective in managing cue-induced cravings in individuals with comorbid AUD-PTSD, highlighting the need for further research to explore its potential mechanisms and effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Oxytocin Administration on Cue-Induced Craving in Co-occurring Alcohol Use Disorder and PTSD: A Within-Participant Randomized Clinical Trial. Stauffer, CS., Meinzer, NK., Morrison, T., et al.[2022]

A mouse model of PTSD demonstrated that chronic stress exposure leads to a long-lasting increase in vulnerability to alcohol relapse, indicating a significant link between PTSD and alcohol use disorder.

Administration of oxytocin effectively blocked the stress-induced alcohol relapse in mice, suggesting its potential as a therapeutic option for individuals with PTSD and alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxytocin Reduces Sensitized Stress-Induced Alcohol Relapse in a Model of Posttraumatic Stress Disorder and Alcohol Use Disorder Comorbidity. Becker, HC., Lopez, MF., King, CE., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

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]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Augmenting Treatment for Posttraumatic Stress Disorder and Co-Occurring Conditions with Oxytocin. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of oxytocin on stress reactivity and craving in veterans with co-occurring PTSD and alcohol use disorder. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Effects of Oxytocin Administration on Cue-Induced Craving in Co-occurring Alcohol Use Disorder and PTSD: A Within-Participant Randomized Clinical Trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Oxytocin Reduces Sensitized Stress-Induced Alcohol Relapse in a Model of Posttraumatic Stress Disorder and Alcohol Use Disorder Comorbidity. [2023]