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Propranolol for PTSD and Alcoholism

Phase 2
Recruiting
Led By Ahmed Hassan, MD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks

Summary

This trial will test the safety and efficacy of using propranolol with CPT to treat PTSD and AUD symptoms.

Who is the study for?
Adults aged 18-70 with PTSD and AUD, who speak English, have had recent heavy drinking episodes, are on antidepressants for PTSD, and agree to use contraception if applicable. Excluded are those with severe medical conditions or contraindications to propranolol, pregnant/breastfeeding women, high suicide risk individuals, users of certain drugs conflicting with the trial medication.
What is being tested?
The study is testing whether Cognitive Processing Therapy (CPT) combined with propranolol is tolerable and effective for treating people with both PTSD and AUD compared to a placebo group. Each participant will undergo CPT for 12 weeks and be assessed up until week 24.
What are the potential side effects?
Propranolol may cause side effects such as dizziness, fatigue, shortness of breath; it can also affect heart rate and blood pressure. It's not suitable for individuals with asthma or certain heart conditions due to potential adverse reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of CPT sessions attended
Secondary study objectives
Alcohol craving
CAPS-5 total symptom severity score
Number of drinks per week (TLFB)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PropranololExperimental Treatment1 Intervention
Medication treatment regimen will consist of 12 weeks of 40 mg immediate-release propranolol BID
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo will be administered BID for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Propranolol
2010
Completed Phase 4
~1290

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
371 Previous Clinical Trials
83,237 Total Patients Enrolled
Ahmed Hassan, MDPrincipal InvestigatorCAMH
1 Previous Clinical Trials
40 Total Patients Enrolled
~5 spots leftby Feb 2025
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