Testing a Novel Therapeutic Strategy for Comorbid Post-Traumatic Stress Disorder and Alcohol Use Disorder
NCT05692271 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2023-10-17
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
- DRUG
-
Propranolol
40 mg teva-propranolol taken twice daily for 12 weeks
- DRUG
-
Matching placebo
Sponsors & Collaborators
-
Centre for Addiction and Mental Health
lead OTHER
Principal Investigators
-
Ahmed Hassan, MD · CAMH
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-15
- Primary Completion
- 2025-02-28
- Completion
- 2025-02-28
Countries
- Canada
Study Locations
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