NCT05692271

Testing a Novel Therapeutic Strategy for Comorbid Post-Traumatic Stress Disorder and Alcohol Use Disorder

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the therapeutic tolerability of the use of Cognitive Processing Therapy (CPT) with propranolol in participants with Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD). The investigators are planning to perform an initial proof -of- concept randomized, placebo- controlled trial evaluating propranolol in participants with PTSD and AUD starting CPT for 12 weeks with three post-treatment follow ups at week-16, week-20, and week-24. Participants with current diagnosis of PTSD and AUD seeking treatment will be randomized to either a propranolol group (n=24) or placebo group (n=24) after enrollment. All participants will receive CPT for 12 weeks after randomization. Primary outcomes will be measured in both groups at the end of the study (week 12).

Conditions

• Stress Disorders, Post-Traumatic
• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Propranolol	40 mg teva-propranolol taken twice daily for 12 weeks
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2023-07-15
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2023-01-20
• Last updated: 2023-10-17

Locations

1 site across 1 country: Canada