Combined Therapy for Alcohol Use Disorder and PTSD

(CPT+RP Trial)

Recruiting at1 trial location

Overseen by Anka A Vujanovic, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Houston

Must be taking: Psychotropic medications

Must not be taking: Psychotropic medications

Disqualifiers: Psychotic disorder, Bipolar, Pregnancy, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test the efficacy of a novel integrative cognitive-behavioral intervention in patients with posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD). Specific Aim 1: Examine the efficacy of CPT-RP, as compared to RP alone, in reducing alcohol frequency (percent days drinking) and quantity (drinks per drinking day) as measured by the Timeline Follow-Back (TLFB). Specific Aim 2: Examine the efficacy of CPT-RP, as compared to RP alone, in reducing PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5). Specific Aim 3: Use ecological momentary assessment (EMA) to evaluate intervention effects on daily alcohol-related cognitions and behaviors through real-time associations with PTSD symptomatology and distress tolerance. Researchers will compare integrative CPT+RP with RP-alone to see if CPT+RP is more efficacious in reducing alcohol use and PTSD symptom severity.

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 treatment for Alcohol Use Disorder and PTSD?

Research shows that Cognitive Processing Therapy (CPT) is effective for PTSD, and when enhanced to address alcohol use, it can significantly improve both PTSD symptoms and alcohol-related problems. Integrated treatments combining cognitive-behavioral therapy for PTSD and substance use disorders have shown promise in reducing symptoms of both conditions. ^{1 2 3 4 5}

Is the combined therapy for Alcohol Use Disorder and PTSD safe for humans?

The research suggests that integrated treatments like Cognitive Processing Therapy (CPT) and Relapse Prevention (RP) are generally safe for individuals with PTSD and Alcohol Use Disorder, as they have been used effectively without major safety concerns reported. ^{1 2 4 6 7}

How is the treatment Cognitive Processing Therapy + Relapse Prevention unique for treating PTSD and Alcohol Use Disorder?

This treatment is unique because it combines Cognitive Processing Therapy, which is effective for PTSD, with Relapse Prevention, which is used for Alcohol Use Disorder, into an integrated approach that addresses both conditions simultaneously, potentially improving outcomes for individuals with both PTSD and AUD. ^{1 2 3 7 8}

Research Team

Sudie Back, PhD

Principal Investigator

Medical University of South Carolina

Anka A Vujanovic, Ph.D.

Principal Investigator

Texas A&M University

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Cognitive Processing Therapy + Relapse Prevention (Behavioral Intervention)
• Relapse Prevention (Behavioral Intervention)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

University of Houston

Lead Sponsor

Trials

155

Recruited

48,600+

Norman Sussman

University of Houston

Chief Medical Officer since 2020

MD from Baylor College of Medicine

Tom Luby

University of Houston

Chief Executive Officer since 2019

PhD in Immunology from the Sackler School of Biomedical Sciences, Tufts University

Texas A&M University

Lead Sponsor

Trials

156

Recruited

28,900+

Jeremy Gibson

Texas A&M University

Chief Medical Officer

MD

William “BJ” Jones

Texas A&M University

Chief Executive Officer

M.S. in Industrial Engineering from Texas A&M University

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Dr. George F. Koob

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Chief Executive Officer since 2014

PhD in Neurobiology from the Scripps Research Institute

Dr. Patricia Powell

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Chief Medical Officer since 2015

MD from an accredited institution

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Dr. Erik Summers

Medical University of South Carolina

Chief Medical Officer

MD from University of Alabama at Birmingham

Dr. Patrick J. Cawley

Medical University of South Carolina

Chief Executive Officer

MD, MBA

Findings from Research

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]

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 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 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]

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]

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]

References

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

Cognitive Processing Therapy or Relapse Prevention for comorbid Posttraumatic Stress Disorder and Alcohol Use Disorder: A randomized clinical trial. [2023]

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

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

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

Behavioral Treatments for Alcohol Use Disorder and Post-Traumatic Stress Disorder. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of treatments for co-occurring substance use disorders and post-traumatic stress disorder. [2022]

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

A Novel, Integrated Cognitive-Behavioral Therapy for Co-Occurring Posttraumatic Stress and Substance Use Disorders: A Case Study. [2020]

6. United States 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. [2023]

7. Ireland pubmed.ncbi.nlm.nih.gov

Within-treatment clinical markers of dropout risk in integrated treatments for comorbid PTSD and alcohol use disorder. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of cognitive behaviour therapy for comorbid post-traumatic stress disorder and alcohol use disorders. [2019]