What side effects are associated with this type of intervention?

Common treatments for Substance Use Disorder (SUD) such as Cognitive Behavioral Therapy (CBT), Motivational Interviewing (MI), and 12-step facilitation generally have minimal physical side effects since they are primarily psychosocial interventions. However, patients may experience emotional discomfort, increased anxiety, or distress when confronting traumatic memories or discussing substance use behaviors. These emotional responses are typically temporary and can be managed with the support of a trained therapist. Overall, these therapies are considered safe and effective for treating SUD and co-occurring conditions like PTSD.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Substance Use Disorder (SUD), including methadone, buprenorphine, and naltrexone for opioid use disorder, and disulfiram, acamprosate, and naltrexone for alcohol use disorder. However, there are no specific FDA-approved medications that combine the treatment of SUD with PTSD. Written Exposure Therapy (WET) is a brief trauma-focused intervention aimed at reducing PTSD symptoms, and while it shows promise, it is not yet an FDA-approved treatment. Current treatments for co-occurring SUD and PTSD often involve a combination of pharmacotherapy for SUD and psychotherapeutic interventions like cognitive-behavioral therapy (CBT) for PTSD.

What other types of research exist?

Promising alternatives to Written Exposure Therapy (WET) for SUD patients with PTSD include: 1) Eye Movement Desensitization and Reprocessing (EMDR), which has shown efficacy in treating post-traumatic and stress-related symptoms in patients with SUD. 2) Web-based Prolonged Exposure Therapy (Web-PE), which has been tested among military personnel and veterans with PTSD. Both therapies focus on trauma and have shown potential in reducing PTSD symptoms in patients with co-occurring SUD.

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Written Exposure Therapy for PTSD in Veterans with Substance Use Disorders (WET Trial)

N/A

Recruiting

Led By Sarah Meshberg-Cohen, PhD MS BS

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meets DSM-5 criteria for PTSD;

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-week post-baseline follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if writing about traumatic experiences (WET) helps Veterans with both substance use issues and PTSD more than other treatments. Veterans will either write about their trauma or a neutral topic over several sessions. The study aims to see if WET can improve PTSD and substance use outcomes. Written Exposure Therapy (WET) is a treatment for PTSD developed through systematic evaluations of expressive writing, requiring limited patient and therapist time with no between-session assignments.

Who is the study for?

This trial is for Veterans approved for substance use disorder (SUD) treatment at VA Connecticut Healthcare System, aged 18 or older, who have both SUD and PTSD. It's not open to those with schizophrenia-type disorders, current severe suicidal or homicidal risks, recent PTSD psychotherapy within the past 6 months, or literacy issues.

What is being tested?

The study tests Written Exposure Therapy (WET), a brief trauma-focused intervention aimed at treating PTSD in Veterans with co-occurring SUD. Participants will be compared to those writing on neutral topics to see if WET leads to better outcomes.

What are the potential side effects?

While specific side effects are not listed for this psychological therapy trial, participants may experience discomfort recalling traumatic events during WET sessions which could temporarily increase stress or anxiety levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with PTSD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-week post-baseline follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-week post-baseline follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-week post-baseline follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PTSD Checklist for DSM-5 (PCL-5)

Secondary study objectives

Timeline Follow-Back (TLFB)

Side effects data

From 2023 Phase 2 trial • 16 Patients • NCT04889664

85%

Fatigue

69%

Other

38%

Headache

38%

Dizziness

23%

Blurred Vision

15%

Difficulty Sleeping

15%

Menstrual Irregularity

15%

Frequent Urination

15%

Nausea/vomiting

Increased Perspiration

Anxiety

Decreased energy

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine and Written Exposure Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Written Exposure TherapyExperimental Treatment1 Intervention

Written Exposure Therapy (WET) plus Treatment As Usual (TAU). WET is a 5 session, evidence-based trauma-focused written narrative exposure treatment. At each session, patients are instructed to write about the same trauma event and therapists provide feedback about adherence and offer suggestions. The first session includes psychoeducation about PTSD and a treatment rationale prior to general trauma narrative writing instructions, and specific instructions for completing the first writing session, before completing the first writing (30 minutes) session. Participants are instructed to write about the same trauma event at each following session, with an emphasis on delving into their deepest emotions and thoughts, in as much detail as possible, about the event. All writing sessions begin with specific instructions from the therapist followed by 30 minutes of writing by the participant.

Group II: Neutral Topic WritingActive Control1 Intervention

Treatment As Usual (TAU) augmented by a neutral topic writing condition. The neutral topic writing condition involves writing about an assigned topic during each of the five writing sessions. As opposed to writing about trauma, the specific focus of this condition is on writing for 30 minutes about topics related to their life without writing about emotions or opinions. Rather, they are asked to write about specific objects or events in detail, as accurately as possible, and with as much description as possible. All writing sessions begin with specific instructions from the therapist followed by 30 minutes of writing by the participant.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Written Exposure Therapy

2021

Completed Phase 2

~370

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Substance Use Disorder (SUD) include Cognitive Behavioral Therapy (CBT), Motivational Enhancement Therapy (MET), and Contingency Management (CM). CBT helps patients identify and modify negative thought patterns and behaviors associated with substance use, enhancing coping strategies. MET focuses on increasing the patient's motivation to change by resolving ambivalence about substance use. CM uses positive reinforcement, such as vouchers or rewards, to encourage abstinence and adherence to treatment. These therapies are crucial for SUD patients as they address both the psychological and behavioral aspects of addiction, which is particularly important for those with co-occurring conditions like PTSD. Effective treatment can reduce substance use and improve overall mental health, aiding in long-term recovery.

Psychotherapy and addiction: a survey of journals.Efficacy of "seeking safety" in a Dutch population of traumatized substance-use disorder outpatients: study protocol of a randomized controlled trial.