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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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of CPT sessions attended

Secondary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor

356 Previous Clinical Trials

81,410 Total Patients Enrolled

16 Trials studying Alcoholism

3,457 Patients Enrolled for Alcoholism

Ahmed Hassan, MDPrincipal InvestigatorCAMH

1 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research effort open to participants aged 20 and over?

"Prospective participants for this study must be above the age of majority and below 70 years old."

Answered by AI

Who is authorized to partake in this experiment?

"This research is in search of 48 individuals with a history of alcoholism, aged between 18 and 70. The list of mandatory requirements includes: Adults aged from 18 to 70 inclusive; Diagnosis for Alcohol Use Disorder within the past 12 months (as per SCID)25); Evidence that they have had at least two episodes of heavy drinking over the last month26; Clinically confirmed current Post-Traumatic Stress Disorder as judged by CAPS-5 on screening27; Taking an antidepressant specifically prescribed for PTSD treatment - this will ensure safety should trauma therapy evoke emotional upset potentially activating depressive symptoms whilst also enabling proper evaluation of propranolol's effect"

Answered by AI

Are there still openings to join this investigation?

"Clinicaltrials.gov verifies that this investigation is currently recruiting trial subjects. The said study was first made available on July 15th 2023 with the last update occurring October 16th of the same year."

Answered by AI

Has Propranolol been certified by the FDA for general use?

"Propranolol was given a score of 2 as there is some evidence suggesting its safety, but no clinical data has been collected to support its efficacy."

Answered by AI

What is the participant count for this scientific experiment?

"Affirmative. Clinicaltrials.gov reports that recruitment for this research endeavor, which was first advertised on July 15th 2023, is ongoing. This trial needs to acquire 48 participants from a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Testing a Novel Therapeutic Strategy for Comorbid Post-Traumatic Stress Disorder and Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05692271.

All > Post Traumatic Stress Disorder > Ptsd