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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
40 mg teva-propranolol taken twice daily for 12 weeks
Matching placebo
CAMH
Toronto, Ontario, Canada
RECRUITINGNumber of CPT sessions attended
Number of CPT (therapy) sessions attended by participants
Time frame: 12 weeks
CAPS-5 total symptom severity score
PTSD symptoms measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores at baseline, midpoint (week-6) and endpoint (week 12); the CAPS-5 total symptom severity score is the sum of severity (rated 0-4) on 20 individual items, where a higher score indicates greater symptom severity
Time frame: 12 weeks
Number of drinks per week (TLFB)
Alcohol consumption to be monitored using the timeline follow-back (TLFB)
Time frame: 12 weeks
Percent heavy drinking days (TLFB)
Percent heavy drinking days will be measured weekly. A "heavy drinking day" will be defined as 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.
Time frame: 12 weeks
Alcohol craving
Alcohol craving will be assessed using the Penn Alcohol Craving Scale (PACS), which includes five items scored on a Likert scale from 0 to 6 Min score=0, max score=30, higher scores indicate greater craving
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.