Alcohol Treatment for Couples with PTSD

Overseen By Julianne Flanagan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Lithium, Methadone, Alpha blockers, others

Disqualifiers: Alcohol use disorder, Psychotic disorders, others

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

Compensation: Varies

Number of Visits: Unknown

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how alcohol misuse and PTSD, a mental health condition triggered by a traumatic event, can lead to violence between partners. Researchers will study couples where one or both partners have experienced PTSD and at least one instance of physical violence. The study involves observing participants in both controlled lab settings and real-life environments over 28 days. Alcohol administration will assess its effects. Individuals who have had two or more heavy drinking episodes in the past month and have experienced partner violence might be a good fit. As an unphased study, this trial offers participants the opportunity to contribute to important research that could lead to better understanding and interventions for those affected by PTSD and alcohol misuse.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications like lithium, methadone, alpha or beta blockers, or cholinergic/anticholinergic drugs, as they could affect the study results.

What prior data suggests that this alcohol administration paradigm is safe?

Research has shown that people with PTSD often use alcohol to manage their symptoms, which can lead to harmful drinking habits. Alcohol misuse and PTSD frequently occur together, making it difficult to distinguish their effects.

In this study, participants will drink alcohol to examine its impact on intimate partner violence (IPV) in individuals with PTSD. Participants will consume alcohol until their breath alcohol level reaches between 0.09 and 0.10, slightly above the legal driving limit in the U.S.

In a controlled setting, researchers can carefully monitor for any issues. While moderate alcohol use is generally safe for most people, personal health conditions and past alcohol use should be considered. If uncertain, consult a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores using alcohol administration as a way to understand its effects on PTSD symptoms within couples. Unlike traditional PTSD treatments, which often involve therapy or medication like SSRIs and SNRIs, this approach examines alcohol's immediate impact on stress and relationship dynamics. By observing how alcohol influences PTSD symptoms and couple interactions, the trial could reveal important insights into alternative therapeutic methods or interventions.

What evidence suggests that alcohol administration is effective for studying alcohol-related intimate partner violence?

Research has shown that people with PTSD are more likely to have problems with alcohol, being 1.2 times more likely to struggle with drinking compared to those without PTSD. Many use alcohol to cope with PTSD symptoms, as it can temporarily ease distress. However, this can lead to a cycle of dependence and may increase the risk of violence, including partner violence. Although alcohol might seem helpful initially, it often worsens PTSD and can lead to more problems with alcohol and partner violence. Participants in this trial will complete an alcohol administration paradigm to study these effects further. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for couples where at least one partner has experienced physical IPV in their current relationship and heavy drinking episodes. Participants must be 21 or older, of any gender or ethnicity, and not operate machinery post-visit. Couples with one partner having PTSD are also included.

Inclusion Criteria

One of us in the relationship has been diagnosed with PTSD.

I am 21 years old or older and my gender or race does not limit my participation.

You must have had at least two occasions of drinking a lot of alcohol in the past month and must have consumed a specific amount of alcohol during a test in the lab.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Alcohol Administration Paradigm

Participants will complete an alcohol administration paradigm with peak breath alcohol concentration of .09-.10 g/dL BrAC

2 hours

Ecological Momentary Assessment

Participants will undergo 28 days of ecological momentary assessment to examine naturalistic intimate partner aggression

28 days

Follow-up

Participants are monitored for safety and effectiveness after the main study activities

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alcohol Administration

Trial Overview The study investigates the impact of alcohol misuse and PTSD on intimate partner violence (IPV) among couples. It involves controlled lab assessments and a 28-day real-world evaluation using ecological momentary assessment (EMA).

How Is the Trial Designed?

Group I: alcohol administration paradigm Experimental Treatment 1 Intervention

Participants will complete an alcohol administration paradigm (peak breath alcohol concentration=.09-.10 g/dL BrAC)

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

The Couple HOPES intervention, designed for couples where one partner has PTSD, showed significant improvements in PTSD symptoms (g = .72) and relationship satisfaction (g = .34) among 17 couples, indicating its potential efficacy.

Participants reported no adverse events and high satisfaction with the intervention, suggesting it is a safe and feasible option for addressing PTSD and enhancing relationship dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An uncontrolled trial of couple HOPES: A guided online couple intervention for PTSD and relationship enhancement. Monson, CM., Wagner, AC., Crenshaw, AO., et al.[2022]

Behavioral couples therapy (BCT) combined with individually based treatment (IBT) significantly reduced PTSD severity in women with drug use disorders over a 1-year follow-up, demonstrating its efficacy in addressing PTSD symptoms.

In a study of 61 women who received 26 therapy sessions over 13 weeks, those in the BCT+IBT group showed notable improvements in PTSD severity compared to the IBT-only group, although the proportion of participants diagnosed with PTSD post-treatment did not differ between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Behavioral Couples Therapy Versus Individual Recovery Counseling for Addressing Posttraumatic Stress Disorder Among Women With Drug Use Disorders. Schumm, JA., O'Farrell, TJ., Murphy, MM., et al.[2020]

In a study of 40 female survivors of intimate partner violence with PTSD and alcohol use disorder, older women and those with fewer dependents were more likely to engage in treatment, highlighting demographic factors that influence treatment retention.

Greater PTSD symptoms related to avoidance/numbing and longer histories of heavy drinking were also linked to higher treatment engagement, suggesting that specific symptom profiles may affect a person's likelihood to participate in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Engagement: Female Survivors of Intimate Partner Violence in Treatment for PTSD and Alcohol Use Disorder. Myers, US., Browne, KC., Norman, SB.[2018]

An 18-month group therapy program for women partners of combat veterans with PTSD utilized group psychotherapy and feminist theory to address key themes such as rescuing, dissociation, and individuation.

The exploration of transference and countertransference within the group setting was beneficial in enhancing both individual therapy outcomes and the overall group process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group therapy for partners of combat veterans with post-traumatic stress disorder. Armstrong, MA., Rose, P.[2019]

In a study involving 9 couples, the Couple Treatment for Alcohol Use Disorder and Posttraumatic Stress Disorder (CTAP) showed promising results, with 8 veterans experiencing significant reductions in PTSD symptoms and a notable decrease in heavy drinking days (effect size d = 1.01).

CTAP also led to clinically reliable reductions in depression for both veterans and their partners, suggesting that this integrated therapy may effectively address comorbid PTSD and alcohol use disorder while also impacting relationship dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Couple Treatment for Alcohol Use Disorder and Posttraumatic Stress Disorder: Pilot Results From U.S. Military Veterans and Their Partners. Schumm, JA., Monson, CM., O'Farrell, TJ., et al.[2018]

Behavioral couples therapy (BCT) was effective for both veterans with combat-related PTSD and those with substance use disorder (SUD) alone, showing significant improvements in relationship satisfaction and reductions in drinking and psychological distress after treatment.

Both groups demonstrated high compliance with BCT, attending many sessions and engaging in additional support like Alcoholics Anonymous, indicating that BCT can be a promising treatment option for veterans with comorbid PTSD and SUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral couples therapy for comorbid substance use disorders and combat-related posttraumatic stress disorder among male veterans: an initial evaluation. Rotunda, RJ., O'Farrell, TJ., Murphy, M., et al.[2018]

In a study involving 353 women in substance abuse treatment, the integrated PTSD treatment (Seeking Safety) did not result in significantly more adverse events compared to a non-trauma-focused intervention (Women's Health Education), indicating that it is safe to implement PTSD treatment in these settings.

Both interventions had low rates of adverse events (9.6% for Seeking Safety and 7.2% for Women's Health Education), suggesting that addressing PTSD in substance abuse programs does not worsen psychiatric or substance use symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in an integrated trauma-focused intervention for women in community substance abuse treatment. Killeen, T., Hien, D., Campbell, A., et al.[2021]

In a 12-week pilot study involving 24 veterans with PTSD and alcohol use disorder, zonisamide (400 mg) was found to be well-tolerated and easily administered alongside cognitive processing therapy (CPT), which also addressed drinking behavior.

While both groups showed significant decreases in drinking outcomes and PTSD symptoms, there was no significant advantage of zonisamide over placebo, although a higher rate of abstinence was observed in the zonisamide group (50% vs 33%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zonisamide as an Adjunctive Treatment to Cognitive Processing Therapy for Veterans With Posttraumatic Stress Disorder and Comorbid Alcohol Use Disorder: A Pilot Study. Petrakis, I., Ralevski, E., Arias, AJ., et al.[2021]

A couples-based treatment called structured approach therapy (SAT) significantly reduced PTSD symptoms in returning veterans compared to a standard educational intervention, with over half of the veterans in the SAT group no longer meeting PTSD criteria after treatment.

SAT also improved relationship dynamics and reduced anxiety for both veterans and their partners, highlighting its effectiveness not just for PTSD but also for enhancing relationship quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of structured approach therapy in reducing PTSD in returning veterans: A randomized clinical trial. Sautter, FJ., Glynn, SM., Cretu, JB., et al.[2019]

Many military service members and veterans with alcohol problems also experience post-traumatic stress disorder (PTSD), highlighting the need for integrated treatment approaches.

Research indicates that treating alcohol problems and PTSD simultaneously may be more effective than addressing each issue separately, suggesting that combined therapies could improve outcomes for affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nature and Treatment of Comorbid Alcohol Problems and Post Traumatic Stress Disorder Among American Military Personnel and Veterans. Allen, JP., Crawford, EF., Kudler, H.[2018]

Over half (52.20%) of respondents with PTSD reported moderate to excessive alcohol use during the war, with 22.92% consuming more alcohol post-war than before, indicating a strong link between PTSD and increased alcohol consumption as a form of self-medication.

Treating alcoholism in PTSD patients is challenging due to the complex interplay of trauma and addiction, which can create significant emotional strain on healthcare providers, similar to the experiences of those treating patients with other severe conditions like AIDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PTSD and alcoholism. Gruden, V., Gruden, V., Gruden, Z.[2015]

Citations

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Comorbidity of Post-Traumatic Stress Disorder and Alcohol ... People with PTSD are more prone to develop drinking problems, with nearly 1.2 times higher incidence than those without PTSD [6]. Up to 75% of ...

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Efficacy and acceptability of interventions for co-occurring ... Results suggest that trauma-focused, non-trauma-focused, and manualized SUD interventions are sound options for individuals with comorbid PTSD/SUD.

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Concurrent Treatment of PTSD and Alcohol Use Disorder ... This trial indicates that integrated treatment for comorbid PTSD and SUD significantly reduces PTSD symptom severity in women with PTSD and AUD ...

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Post-traumatic stress and future substance use outcomes Conclusion: PTSD symptoms were highly associated with tobacco and alcohol use, while the association with prospective cannabis use is not clear.