Combined Therapy for Alcohol Use Disorder and PTSD

(CPT+RP Trial)

Recruiting at 1 trial location

Overseen By Sudie E Back, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Houston

Must be taking: Psychotropic medications

Must not be taking: Psychotropic medications

Disqualifiers: Psychotic disorder, Bipolar, Pregnancy, 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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 6-9 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combined therapy to help individuals with both PTSD and alcohol use disorder (AUD) manage their symptoms more effectively. The study compares two groups: one receiving cognitive processing therapy combined with relapse prevention (CPT+RP) and another receiving only relapse prevention (RP). Researchers aim to determine if the combined therapy reduces both drinking habits and PTSD symptoms more effectively. Individuals who drink heavily most days and have PTSD symptoms might be suitable candidates.

As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Cognitive Processing Therapy (CPT) and Relapse Prevention (RP) have been studied separately and are safe for people with PTSD and alcohol use disorder (AUD). Past studies indicate that CPT is generally easy for people to handle, with most side effects being mild and temporary, such as increased emotionality during sessions. RP is also safe and focuses on teaching skills to manage cravings and prevent relapse.

No serious side effects have been reported with these therapies in the past. The current trial is in Phase 2, indicating that earlier research has already assessed safety. While combining CPT and RP is new, each therapy has a strong safety record individually, suggesting that most people handle the combined treatment well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Combined Therapy for Alcohol Use Disorder (AUD) and PTSD because it uniquely integrates Cognitive Processing Therapy (CPT) with Relapse Prevention (RP). Unlike standard treatments that typically address AUD and PTSD separately, this approach tackles both conditions simultaneously, recognizing their interconnectedness. The therapy teaches patients how to manage triggers and cravings while also addressing trauma-related thoughts through cognitive restructuring exercises. This dual-focus method not only targets the root causes of alcohol use but also helps reduce PTSD symptoms, offering a more comprehensive treatment option for individuals struggling with both conditions.

What evidence suggests that this trial's treatments could be effective for PTSD and alcohol use disorder?

Research has shown that combining Cognitive Processing Therapy (CPT) and Relapse Prevention (RP) could benefit people with both PTSD and Alcohol Use Disorder (AUD). In this trial, one group of participants will receive the integrated CPT+RP treatment, which addresses the interconnected nature of PTSD and AUD. Studies have found that CPT reduces PTSD symptoms by addressing negative thoughts from trauma, while RP prevents alcohol relapse by teaching coping skills. Previous patients who received similar treatments showed decreases in both alcohol use and PTSD symptoms. This suggests that using CPT and RP together might effectively help people manage both conditions. ^{1 2 3 6 7}

Who Is on the Research Team?

Anka A Vujanovic, Ph.D.

Principal Investigator

Texas A&M University

Sudie Back, PhD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with both PTSD and moderate to severe alcohol use disorder, who can consent and understand English. It's not for those with bipolar disorder or other specific conditions. Participants should have a recent history of heavy drinking as defined in the study.

Inclusion Criteria

Meet DSM-5 diagnostic criteria for current (past month) moderate to severe alcohol use disorder (> 4 criteria)

Participants may also meet criteria for a mood disorder or anxiety disorders. Concurrent substance use disorders are acceptable provided alcohol is the participant's primary substance of choice

Ability to understand English

Exclusion Criteria

Acute alcohol withdrawal as indicated by CIWA-Ar scores >8

Meeting DSM-5 criteria for a history of or current psychotic disorder or bipolar disorder, or imminent risk of suicidal or homicidal behavior

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12, 90-minute individual sessions of CPT+RP or RP alone, delivered twice-weekly

6-9 weeks

12 visits (in-person)

Follow-up

Participants are monitored for changes in alcohol use and PTSD symptoms

12 months

Assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Processing Therapy + Relapse Prevention
• Relapse Prevention

Trial Overview The study tests if Cognitive Processing Therapy combined with Relapse Prevention (CPT+RP) is better than just Relapse Prevention (RP) at reducing how often and how much participants drink, as well as easing PTSD symptoms.

How Is the Trial Designed?

Group I: Integrated Cognitive Processing Therapy and Relapse Prevention (CPT+RP) Experimental Treatment 1 Intervention

Participants will receive 12, 90-minute individual sessions of CPT+RP delivered twice-weekly. We will offer some flexibility (e.g., due to illness or scheduling conflicts) and allow up to 9 weeks to complete all 12 sessions if needed. During CPT+RP, patients receive psychoeducation pertaining to the interconnectedness of AUD and PTSD and learn techniques to identify and manage triggers for alcohol use, cope with cravings, address problem thoughts about drinking, and enhance social support. These skills address core functional outcomes relevant to addiction, including executive functioning, incentive salience, and negative emotionality. The PTSD treatment component of CPT+RP reduces PTSD symptoms via identifying and targeting maladaptive trauma-related cognitions, beliefs, and Stuck Points via cognitive restructuring exercises, such as Socratic questioning. RP skills are integrated within each session.

Group II: Relapse Prevention (RP) Active Control 1 Intervention

Participants will receive 12, 90-minute individual sessions of RP delivered twice-weekly as consistent with the experimental condition. The RP manual is adapted from the NIAAA Project MATCH Cognitive-Behavioral Coping Skills Therapy Manual and has been used in prior NIH-funded trials of integrated, trauma-focused treatment. Session topics include, for example, Triggers for Alcohol Use, Coping with Cravings and Urges to Drink (e.g., avoid alcohol cues, distracting activities, talk to friends/family, urge surfing), Managing Thoughts about Alcohol and Drinking by challenging and changing thoughts, Planning for Emergencies and Coping with a Lapse, Drink Refusal Skills, Increasing Pleasant Activities and Enhancing Social Support.

Cognitive Processing Therapy + Relapse Prevention is already approved in United States for the following indications:

Approved in United States as CPT-RP for:

• Posttraumatic Stress Disorder (PTSD)
• Alcohol Use Disorder (AUD)

Who Is Running the Clinical Trial?

University of Houston

Lead Sponsor

Trials

155

Recruited

48,600+

Texas A&M University

Lead Sponsor

Trials

156

Recruited

28,900+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

Behavioral interventions for treating alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) include a variety of evidence-based approaches, such as relapse prevention and cognitive processing therapy, which can help improve outcomes for individuals with these conditions.

Integrated treatment models that address both AUD and PTSD simultaneously may be more effective than sequential treatments, highlighting the need for further research to tailor interventions based on individual characteristics like gender and treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Treatments for Alcohol Use Disorder and Post-Traumatic Stress Disorder. Flanagan, JC., Jones, JL., Jarnecke, AM., et al.[2023]

In a study of 127 active-duty military personnel, those with hazardous drinking were just as likely to respond positively to cognitive processing therapy (CPT) for PTSD as those without hazardous drinking, showing that CPT is effective regardless of drinking status.

Participants with hazardous drinking not only showed significant reductions in PTSD symptoms but also had a decrease in their drinking behaviors over the course of treatment, indicating that CPT can be beneficial for both PTSD and hazardous drinking without requiring more treatment sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment responder status and time to response as a function of hazardous drinking among active-duty military receiving variable-length cognitive processing therapy for posttraumatic stress disorder. LoSavio, ST., Straud, CL., Dondanville, KA., et al.[2023]

A 12-week course of modified Cognitive Processing Therapy (CPT-C) effectively improved PTSD symptoms and reduced alcohol dependence in a combat veteran, showing promise for treating co-occurring conditions.

The veteran maintained significant improvements in both PTSD and alcohol-related issues 12 weeks after completing the treatment, suggesting the long-term efficacy of this enhanced therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report on the use of cognitive processing therapy-cognitive, enhanced to address heavy alcohol use. McCarthy, E., Petrakis, I.[2022]

Cognitive Processing Therapy (CPT) significantly reduced PTSD symptoms compared to assessment-only (AO) in participants with both PTSD and Alcohol Use Disorder (AUD), indicating its efficacy in treating PTSD in this population.

Both CPT and Relapse Prevention (RP) treatments led to a significant decrease in heavy drinking days compared to AO, suggesting that targeted therapies for PTSD and AUD can positively impact both conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Processing Therapy or Relapse Prevention for comorbid Posttraumatic Stress Disorder and Alcohol Use Disorder: A randomized clinical trial. Simpson, TL., Kaysen, DL., Fleming, CB., et al.[2023]

Integrated cognitive behaviour therapy (CBT) for PTSD and alcohol use disorders (AUD) showed that participants receiving exposure therapy had a significantly higher rate of clinically meaningful improvement in PTSD severity compared to those receiving standard alcohol-support therapy (60% vs 39%).

While both therapies reduced PTSD severity, participants in the alcohol-support group reported greater reductions in alcohol consumption and dependence, suggesting that tailored approaches may be necessary for optimal outcomes in individuals with coexisting PTSD and AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of cognitive behaviour therapy for comorbid post-traumatic stress disorder and alcohol use disorders. Sannibale, C., Teesson, M., Creamer, M., et al.[2019]

In a study involving 221 participants with PTSD and substance use disorders, integrated cognitive-behavioral therapy (ICBT) showed better outcomes in reducing drug use compared to individual addiction counseling (IAC) and standard care (SC), although PTSD symptoms improved similarly across all groups.

ICBT also resulted in higher therapy retention rates than IAC, indicating that patients were more likely to continue treatment, and there were no unexpected adverse events reported during the trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder. McGovern, MP., Lambert-Harris, C., Xie, H., et al.[2022]

In a study of 110 veterans undergoing treatment for comorbid PTSD and alcohol use disorder, increased alcohol consumption during therapy was linked to a significantly higher risk of dropping out, particularly in those receiving integrated exposure therapy.

Specifically, for each additional drink consumed per day, the risk of dropout increased fivefold, highlighting the importance of monitoring alcohol use as a potential marker for patient retention in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Within-treatment clinical markers of dropout risk in integrated treatments for comorbid PTSD and alcohol use disorder. Kline, AC., Panza, KE., Harlé, KM., et al.[2023]

The TIPSS program, which combines cognitive processing therapy for PTSD with cognitive-behavioral therapy for substance use disorders, shows promise in treating individuals with both conditions, as demonstrated in a case study of a woman with PTSD and substance dependence.

This integrated approach effectively reduced both PTSD symptoms and substance use, highlighting its potential as a novel treatment for the common comorbidity of PTSD and substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel, Integrated Cognitive-Behavioral Therapy for Co-Occurring Posttraumatic Stress and Substance Use Disorders: A Case Study. Vujanovic, AA., Smith, LJ., Tipton, KP., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05959434?locStr=United+States&country=United+States&aggFilters=status%3A

Integration of Cognitive Processing Therapy and Relapse ... A substantial proportion of individuals with alcohol use disorder (AUD) also meet criteria for posttraumatic stress disorder (PTSD). The co-occurrence of AUD/ ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12383005/

Integrated Cognitive Processing Therapy and Relapse ... Posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) often co-occur and present significant treatment challenges. Cognitive ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0276111

Cognitive Processing Therapy or Relapse Prevention for ... To compare a Posttraumatic Stress Disorder (PTSD) treatment (Cognitive Processing Therapy; CPT), an Alcohol Use Disorder (AUD) treatment (Relapse Prevention; ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9707793/

Cognitive Processing Therapy or Relapse Prevention for ... To compare a Posttraumatic Stress Disorder (PTSD) treatment (Cognitive Processing Therapy; CPT), an Alcohol Use Disorder (AUD) treatment ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05959434/integration-of-cognitive-processing-therapy-and-relapse-prevention-for-alcohol-use-disorder-and-ptsd?state=TX&city=College%20Station

Integration of Cognitive Processing Therapy and Relapse ... The goal of this clinical trial is to test the efficacy of a novel integrative cognitive-behavioral intervention in patients with ...

6. research.tamu.edu research.tamu.edu/study/integration-of-cognitive-processing-therapy-and-relapse-prevention-for-alcohol-use-disorder-and-co-occurring-ptsd-a-randomized-clinical-trial-2/

Integration of Cognitive Processing Therapy and Relapse ... The study is led by Dr. Anka Vujanovic at Texas A&M and Dr. Sudie Back at the Medical University of South Carolina. Both are licensed clinical psychologists ...

7. taggs.hhs.gov taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=R01AA030157&arg_ProgOfficeCode=100

Award Information | HHS TAGGS Integration of Cognitive Processing Therapy and Relapse Prevention for Alcohol Use Disorder and Co-Occurring PTSD: A Randomized Clinical Trial ...