Propranolol for PTSD and Alcoholism

Overseen By Justin Matheson, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Centre for Addiction and Mental Health

Must be taking: Antidepressants

Must not be taking: Anti-arrhythmics, Calcium channel blockers

Disqualifiers: Asthma, Diabetes, Arrhythmia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether propranolol, a heart medication, can aid individuals with both Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD) when combined with therapy. Participants will be divided into two groups: one will receive propranolol, and the other will receive a placebo (a pill with no active ingredient), both alongside Cognitive Processing Therapy for 12 weeks. The trial aims to determine if propranolol can enhance the effectiveness of therapy or make it easier to manage. Individuals with both PTSD and AUD who are already on antidepressants might be suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Do I have to stop taking my current medications for the trial?

The trial requires participants to be on an antidepressant for PTSD. You cannot start new therapies or anti-craving medications during the trial unless you've been on them for at least 6 months. The protocol does not specify stopping other medications, but you cannot use medications that interact with propranolol, like anti-arrhythmic drugs or calcium channel blockers.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that propranolol is generally safe for use. Studies have found that it can help lessen PTSD (Post-Traumatic Stress Disorder) symptoms, such as anxiety from troubling memories. The medication calms the body's stress response, which can benefit those with PTSD.

In studies comparing propranolol to a placebo (a pill with no active medicine), participants taking propranolol reported fewer PTSD symptoms. This suggests that the drug might help reduce distress linked to traumatic memories. Research supports its safety in these cases, with no major side effects reported in most studies.

The FDA has already approved propranolol for other conditions, like high blood pressure and certain heart problems, which adds confidence in its safety. However, like any medication, some risks or side effects may occur, so it's important to consult healthcare providers before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PTSD and alcoholism?

Researchers are excited about propranolol for PTSD and alcoholism because it offers a unique approach by potentially addressing both conditions simultaneously. Unlike standard treatments that often focus on just one condition, propranolol targets the physiological symptoms of anxiety and stress by blocking adrenaline's effects, which could be particularly beneficial for PTSD. In addition, because it's a beta-blocker, it might help reduce cravings and withdrawal symptoms in alcoholism, offering a new avenue for dual-diagnosis treatment. This dual-action could make propranolol a promising option for individuals struggling with both PTSD and alcohol dependency.

What evidence suggests that propranolol could be an effective treatment for PTSD and AUD?

Research suggests that propranolol, which participants in this trial may receive, might help reduce PTSD symptoms. Some studies have shown it can lessen these symptoms when taken before recalling traumatic memories, potentially reducing anxiety and stress. However, results are mixed regarding its effectiveness for alcoholism. Some evidence suggests it could be helpful, but more research is needed to confirm this. Overall, propranolol shows promise, but its effectiveness for treating both PTSD and alcohol use disorder together remains under investigation. Participants in this trial will receive either propranolol or a placebo to further explore these effects. ^{1 5 6 7 8}

Who Is on the Research Team?

Ahmed Hassan, MD

Principal Investigator

CAMH

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Has a minimum of two episodes of heavy drinking in the past 30 days

I have been diagnosed with PTSD by a professional using the CAPS-5.

Able to speak and read in English

Exclusion Criteria

Pregnant or breastfeeding women

Basal systolic blood pressure < 100 mm Hg or basal heart rate < 55 beats/minute

Diagnosed with psychotic disorder or bipolar disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive Processing Therapy (CPT) with either propranolol or placebo for 12 weeks

12 weeks

Weekly therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

3 visits at week-16, week-20, and week-24

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Propranolol

Trial Overview 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.

How Is the Trial Designed?

Group I: Propranolol Experimental Treatment 1 Intervention

Medication treatment regimen will consist of 12 weeks of 40 mg immediate-release propranolol BID

Group II: Placebo Placebo Group 1 Intervention

Matching placebo will be administered BID for 12 weeks

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Published Research Related to This Trial

In patients undergoing withdrawal from chronic alcoholism, propranolol effectively normalizes increased cardiac output and reduces peripheral vascular resistance, leading to a calming effect, as observed in a double-blind study.

Propranolol was found to be more effective than diazepam in alleviating symptoms of psychic tension associated with alcohol withdrawal, with minimal side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propranolol in the treatment of alchoholism: a review. Carlsson, C.[2013]

In a study using male Wistar rats, the β1/2 adrenergic receptor antagonist propranolol significantly reduced alcohol drinking, particularly showing a trend towards greater impact on compulsion-like alcohol drinking (CLAD) compared to alcohol-only drinking (AOD).

While propranolol and betaxolol showed potential in decreasing alcohol consumption, they may also cause undesirable side effects, and their effects on specific brain areas related to drinking did not yield expected results, suggesting a complex role of the noradrenergic system in alcohol use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of beta- and alpha-adrenergic receptors on alcohol drinking. De Oliveira Sergio, T., Wean, S., Katner, SN., et al.[2023]

In a 6-week study involving 29 patients with agoraphobia and panic disorder, both propranolol and alprazolam were effective in reducing panic attacks and avoidance behavior.

Alprazolam showed a faster onset of its effects compared to propranolol, suggesting that while both medications work, propranolol may need further investigation to fully understand its potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled study of alprazolam and propranolol in panic-disordered and agoraphobic outpatients. Ravaris, CL., Friedman, MJ., Hauri, PJ., et al.[2013]

In a 6-week clinical trial involving 60 adults with long-standing PTSD, propranolol significantly reduced PTSD symptoms compared to a placebo, with a notable effect size of 1.76 for the Clinician-Administered PTSD Scale (CAPS).

The study suggests that administering propranolol before trauma memory reactivation sessions is an effective treatment strategy for PTSD, indicating its potential as a novel therapeutic approach based on reconsolidation theory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of PTSD Symptoms With Pre-Reactivation Propranolol Therapy: A Randomized Controlled Trial. Brunet, A., Saumier, D., Liu, A., et al.[2019]

In a study involving 52 patients with dental anxiety, perioperative propranolol did not significantly reduce dental anxiety compared to a placebo, indicating it may not be effective for this specific type of fear.

Both the propranolol and placebo groups showed a decrease in dental anxiety over time, but the lack of significant difference suggests that propranolol does not provide additional benefits for patients with dental phobia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Propranolol Against Dental Anxiety: A Randomized Controlled Trial. Steenen, SA., Su, N., van Westrhenen, R., et al.[2022]

In a study of 66 adults with longstanding PTSD, both propranolol and placebo led to significant reductions in PTSD and depression symptoms during treatment, but there was no significant difference between the two groups.

However, for patients with severe PTSD symptoms, those treated with propranolol showed continued improvement in symptoms three months after treatment, while those on placebo experienced a worsening, suggesting that propranolol may have long-term benefits for certain individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traumatic memory reactivation with or without propranolol for PTSD and comorbid MD symptoms: a randomised clinical trial. Roullet, P., Vaiva, G., Véry, E., et al.[2021]

A systematic review of eight studies involving 302 participants found that propranolol did not show significant efficacy compared to placebo or benzodiazepines in treating anxiety disorders, including panic disorder and PTSD.

The evidence is currently insufficient to recommend propranolol as a routine treatment for anxiety disorders, as it did not demonstrate a clear benefit in alleviating symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propranolol for the treatment of anxiety disorders: Systematic review and meta-analysis. Steenen, SA., van Wijk, AJ., van der Heijden, GJ., et al.[2022]

A 44-year-old woman with severe PTSD symptoms from multiple motor vehicle accidents showed rapid improvement after starting propranolol (60 mg twice daily) just 48 hours post-trauma, with her PTSD rating score dropping significantly from 86 to 56 within 11 days.

This case suggests that propranolol may be effective in preventing or reducing reemergent PTSD symptoms, marking a novel application for this medication in trauma-related conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propranolol for reemergent posttraumatic stress disorder following an event of retraumatization: a case study. Taylor, F., Cahill, L.[2013]

A study involving six healthy adult volunteers tested four different brands of propranolol (Inderal, Ciplar, Corbeta, and Propal) to assess variations in how the body absorbs and responds to the medication.

The results showed no significant differences in the pharmacokinetic (how the drug is processed in the body) and pharmacodynamic (the drug's effects on the body) parameters among the brands, indicating they are likely interchangeable in terms of efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative pharmacokinetic and pharmacodynamic study of four different brands of propranolol in normal volunteers. Biswas, NR., Garg, SK., Kumar, N., et al.[2013]

Citations

1. withpower.com withpower.com/trial/propranolol-for-ptsd-and-alcoholism-e9ffe

Propranolol for PTSD and Alcoholism The available research shows mixed results for the effectiveness of Propranolol in treating PTSD and alcoholism. In one case study, a woman with severe PTSD ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK562942/

Propranolol for Post-Traumatic Stress Disorder - NCBI - NIH Propranolol administered prior to trauma memory reactivation decreased the severity of PTSD symptoms, reduced physiological responses (eg, heart rate, skin ...

3. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1545493/full

Systematic review and meta-analysis of propranolol in the ... This systematic review and meta-analysis provide preliminary evidence supporting the possible role of propranolol in alleviating PTSD symptoms.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6561397/

Pharmacotherapy for Co-Occurring Alcohol Use Disorder ... Of the two studies that evaluated prazosin for co-occurring AUD and PTSD, only one found an effect on drinking behavior,28 and neither found an effect on PTSD ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00158262

Effect of Propranolol on Preventing Posttraumatic Stress ... This study will assess the effectiveness of taking propranolol soon after a traumatizing incident in reducing the incidence and severity of posttraumatic stress ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01555554

Perioperative Propranolol in Patients With Post Traumatic ... At present, there are no data on the effects of perioperative beta blocker therapy in patients with PTSD, despite the rising significance of PTSD in Veteran ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00645450

PTSD Symptom Reduction by Propranolol Given After ... This study is a randomized, double-blind, placebo-controlled clinical trial of propranolol combined with trauma memory reactivation, to determination if ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9456064/

Propranolol versus Other Selected Drugs in the Treatment of ... According to a meta-analysis, propranolol may be useful in the treatment of anxiety disorders caused by unsettling memories, notably PTSD [46].