Propranolol for PTSD and Alcoholism
Recruiting in Palo Alto (17 mi)
Overseen byAhmed Hassan, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Centre for Addiction and Mental Health
Prior Safety Data
Trial Summary
What is the purpose of this trial?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).
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.
What data supports the idea that Propranolol for PTSD and Alcoholism is an effective drug?
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 symptoms experienced a rapid reduction in symptoms after taking Propranolol following a traumatic event. However, a larger study found that Propranolol did not significantly outperform a placebo in reducing PTSD symptoms over a six-week period, although it showed some benefits for patients with severe symptoms. For alcoholism, Propranolol was found to help calm patients during withdrawal and was more effective than another medication, diazepam, in reducing tension symptoms. Overall, while there are some positive findings, the evidence is not strong enough to conclusively support Propranolol as an effective treatment for PTSD and alcoholism.
12345What safety data exists for propranolol in treating PTSD and alcoholism?
The available studies on propranolol primarily focus on its use for anxiety disorders and PTSD. A systematic review found insufficient evidence to support its routine use for anxiety disorders, including PTSD. A controlled study showed propranolol was effective in reducing panic attacks, but with a slower onset compared to alprazolam. A case study reported rapid reduction of PTSD symptoms with propranolol after a traumatic event. No significant safety concerns were highlighted in these studies, but further research is suggested. No specific data on alcoholism treatment was found.
12467Is the drug Propranolol promising for treating PTSD and Alcoholism?
Propranolol shows promise in reducing alcohol consumption and may help with PTSD symptoms by blocking memory reconsolidation. It has been effective in some studies for reducing panic attacks and avoidance behavior, suggesting potential benefits for PTSD and alcoholism.
12689Eligibility Criteria
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 am between 18 and 70 years old.
I have been diagnosed with PTSD by a professional using the CAPS-5.
+6 more
Exclusion Criteria
Pregnant or breastfeeding women
Basal systolic blood pressure < 100 mm Hg or basal heart rate < 55 beats/minute
I do not have a severe illness that makes it unsafe for me to join the study.
+9 more
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
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Who Is Running the Clinical Trial?
Centre for Addiction and Mental HealthLead Sponsor
References
Propranolol for the treatment of anxiety disorders: Systematic review and meta-analysis. [2022]The effects of propranolol in the treatment of anxiety disorders have not been systematically evaluated previously. The aim was to conduct a systematic review and meta-analysis of randomised controlled trials, addressing the efficacy of oral propranolol versus placebo or other medication as a treatment for alleviating either state or trait anxiety in patients suffering from anxiety disorders. Eight studies met the inclusion criteria. These studies concerned panic disorder with or without agoraphobia (four studies, total n = 130), specific phobia (two studies, total n = 37), social phobia (one study, n = 16), and posttraumatic stress disorder (PTSD) (one study, n = 19). Three out of four panic disorder trials qualified for pooled analyses. These meta-analyses found no statistically significant differences between the efficacy of propranolol and benzodiazepines regarding the short-term treatment of panic disorder with or without agoraphobia. Also, no evidence was found for effects of propranolol on PTSD symptom severity through inhibition of memory reconsolidation. In conclusion, the quality of evidence for the efficacy of propranolol at present is insufficient to support the routine use of propranolol in the treatment of any of the anxiety disorders.
Perioperative Propranolol Against Dental Anxiety: A Randomized Controlled Trial. [2022]Promising results from a trauma reactivation study on post-traumatic stress disorder suggest that propranolol is capable of attenuating symptoms of traumatically induced mental disorders by blocking memory reconsolidation.
Traumatic memory reactivation with or without propranolol for PTSD and comorbid MD symptoms: a randomised clinical trial. [2021]Post-traumatic stress disorder (PTSD) is difficult to treat but one promising strategy is to block memory reconsolidation of the traumatic event. This study aimed to evaluate the efficacy of traumatic memory reactivation under the influence of propranolol, a noradrenergic beta-receptor blocker, in reducing PTSD symptoms as well as comorbid major depression (MD) symptoms. We conducted a double blind, placebo-controlled, randomised clinical trial in 66 adults diagnosed with longstanding PTSD. Propranolol or a placebo was administered 90 min before a brief memory reactivation session, once a week for 6 consecutive weeks. Measures included the SCID PTSD module, the PTSD Check List (PCL-S) and the Beck Depression Inventory-II (BDI-II). PTSD symptoms decreased both in the pre-reactivation propranolol group (39.28%) and the pre-reactivation placebo group (34.48 %). During the 6 treatment sessions, PCL-S and BDI-II scores decreased to similar extent in both groups and there were no treatment differences. During the 3-month follow-up period, there were no treatment effects for the mean PCL-S and BDI-II scores. However, in patients with severe PTSD symptoms (PCL-S ≥ 65) before treatment, PCL-S and BDI-II scores continued to decline 3 months after the end of treatment in the propranolol group while they increased in the placebo group. Repeated traumatic memory reactivation seemed to be effective for PTSD and comorbid MD symptoms. However, the efficacy of propranolol was not greater than that of placebo 1 week post treatment. Furthermore, in this traumatic memory reactivation, PTSD symptom severity at baseline might have influenced the post-treatment effect of propranolol.
Propranolol for reemergent posttraumatic stress disorder following an event of retraumatization: a case study. [2013]This case report concerns a 44-year-old woman who experienced 5 similar motor vehicle accidents, the last 3 causing severe PTSD episodes of over 6 months each, despite multiple pharmacotherapies. Following a 6th accident, severe PTSD symptoms reemerged. Forty-eight hours after this trauma, propranolol (60 mg) orally, twice a day (1.75 mg/kg/day) was begun, and the PTSD symptoms were rapidly and markedly reduced. The Clinician-Administered PTSD Rating Scale score was reduced from an initial 86 to 56 by 11 days posttrauma. To our knowledge, this is the first report of the effects of propranolol treatment on reemergent PTSD symptoms. Propranolol may be particularly efficacious in the prevention of initial or reemergent PTSD symptoms.
Propranolol in the treatment of alchoholism: a review. [2013]In the withdrawal phase of chronic alcoholism, hyperkinetic circulation, characterized by increased cardiac output, is the rule. Even in alcoholics who have been sober for a long time, increased cardiac output is very common and these changes are similar to those seen in some patients with labile hypertension. This could be caused by psychic tension. In the withdrawal phase propranolol was found to normalize the circulation and to reverse the decreased peripheral vascular resistance. We observed that the patients seemed to be calm after 40 mg of propranolol by mouth. In a double blind study of propranolol and placebo this effect was confirmed and in another study 120 mg of propranolol a day was compared to 30 mg of diazepam a day (double-blind, crossover). Using different psychological methods all significant differences are in favour of propranolol. The findings are in agreement with other reports. It is our clinical impression that propranolol is a useful drug for psychic tension symptoms in chronic alcoholism. Very few side effects have been found.
A controlled study of alprazolam and propranolol in panic-disordered and agoraphobic outpatients. [2013]We studied the efficacy of propranolol (Inderal) compared to alprazolam (Xanax) in 29 patients with a diagnosis of agoraphobia with panic disorder or panic disorder with or without limited phobic avoidance in a 6-week double-blind controlled experiment. Alprazolam is effective in those syndromes, whereas to date only negative or ambiguous results had been reported for propranolol. Fourteen patients received a mean daily dose of 5.0 +/- 2.3 mg of alprazolam and 15 patients received 182.0 +/- 60.5 mg mean daily dose of propranolol. We found both drugs to be effective to suppress panic attacks and reduce avoidance behavior. The only significant between-drug difference was a more rapid onset of alprazolam's panicolytic effect. Propranolol merits further study. We suggest patients worthy of a clinical trial.
Comparative pharmacokinetic and pharmacodynamic study of four different brands of propranolol in normal volunteers. [2013]The pharmacokinetic and pharmacodynamic studies of four different brands of propranolol (Inderal, Ciplar, Corbeta and Propal) were carried out after single and multiple dosing on six normal adult healthy volunteers in a randomized crossover fashion to determine any inter-brand variations in bioavailability and pharmacodynamic effects. No significant difference was observed in any of the pharmacokinetic and pharmacodynamic parameters of four different brands of propranolol studied.
Reduction of PTSD Symptoms With Pre-Reactivation Propranolol Therapy: A Randomized Controlled Trial. [2019]The authors assessed the efficacy of trauma memory reactivation performed under the influence of propranolol, a noradrenergic beta-receptor blocker, as a putative reconsolidation blocker, in reducing symptoms of posttraumatic stress disorder (PTSD).
The role of beta- and alpha-adrenergic receptors on alcohol drinking. [2023]Alcohol Use Disorders (AUD) is characterized by compulsion-like alcohol drinking (CLAD), where intake despite negative consequences can be a major clinical obstacle. With few treatment options available for AUD, there is a significant need for novel therapies. The noradrenergic system is an important hub for regulating stress responses and maladaptive drives for alcohol. Studies have shown that drugs targeting α1 adrenenergic receptors (ARs) may represent a pharmacological treatment for pathological drinking. However, the involvement of β ARs for treating human drinking has received scant investigation, and thus we sought to provide pre-clinical validation for possible AR utility for CLAD by analyzing whether β AR antagonists propranolol (β1/2), betaxolol (β1), and ICI, 118,551 (β2) impacted CLAD and alcohol-only drinking (AOD) in male Wistar rats. We found that the highest dose of propranolol tested systemically (10 mg/kg) reduced alcohol drinking, while 5 mg/kg propranolol reduced drinking with a trend to impact CLAD more than AOD, and with no effects of 2.5 mg/kg. Betaxolol (2.5 mg/kg) also decreased drinking, while ICI 118.551 had no effects. Also, while AR compounds might have utility for AUD, they can also lead to undesirable side effects. Here, a combination of ineffective doses of propranolol and prazosin reduced both CLAD and AOD. Finally, we investigated the effect of propranolol and betaxolol in two brain areas related to pathological drinking, the anterior insula (aINS) and medial prefrontal cortex (mPFC). Surprisingly, propranolol (1-10 μg) in aINS or mPFC did not affect CLAD or AOD. Together, our findings provide new pharmacological insights into noradrenergic regulation of alcohol consumption, which may inform AUD therapy.