Testing a Novel Therapeutic Strategy for Comorbid Post-Traumatic Stress Disorder and Alcohol Use … (NCT05692271) | Clinical Trial Compass
CompletedPhase 2
Testing a Novel Therapeutic Strategy for Comorbid Post-Traumatic Stress Disorder and Alcohol Use Disorder
Canada48 participantsStarted 2023-07-15
Plain-language summary
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).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults between 18 and 70 years old inclusively
. Diagnosed with AUD in the past year (according to the Structured Clinical Interview for DSM-5 (SCID)25). This will include active drinkers and recently abstained drinkers.
. has a minimum of two episodes of heavy drinking (≥5 drinks in a single day for men and ≥4 drinks in a single day for women) in the past 30 days as used in other trials26
. Diagnosed with current (past 30 days) PTSD with the Clinician- Administered PTSD Scale for DSM-5 (CAPS-5) on screening27
. On an antidepressant as treatment of PTSD (to ensure safety and homogeneity as PTSD treatment of study population). Antidepressants are the first-line treatment for PTSD as well major depression which commonly comorbid PTSD. The presence of antidepressants in study recruitment criteria will ensure additional safety if the trauma focused therapy triggered emotional distress which could temporarily activate depressive symptoms. The presence of antidepressants in all study participants will also ensure proper evaluation of the effect of propranolol without any confounders effect.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was testing Cognitive Processing Therapy (CPT) for people dealing with both PTSD and alcohol use disorder at the same time — is that combination of conditions a good match for my specific situation, and would my doctor consider CPT a reasonable approach for me?
2Since this is a Phase 2 trial that has already completed, what do the early results suggest about whether this kind of combined treatment approach was safe and showed any signs of working, and has my doctor seen any findings from it?
3The trial measured how many CPT sessions participants actually attended — does that suggest people had trouble completing the full course of treatment, and what does my doctor think about my ability to commit to that kind of therapy schedule given everything else I'm managing?
4Because this is still a Phase 2 study, there may be limited data on long-term safety and effectiveness — would my doctor recommend I consider a more established treatment for PTSD or alcohol use disorder first, rather than waiting to see if this approach moves forward?
5Are there other ongoing or completed trials, or standard-of-care options, that address both PTSD and alcohol use disorder together that my doctor thinks I should compare this approach against?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Agrees (if the participant is female and of childbearing potential) to use at least one of the following highly effective methods of contraception, such as hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation or alternatively double barrier method.
. Agrees not to start any other therapy including self-help group during the trial period. Exception will be made for participants who had already started therapy and have been attending the sessions for at least 6 months.
. Agrees not to start any anti-craving medications for alcohol use during the trial period. Exception will be made for participants who were already taking an anti-craving medication for at least 6 months.
Exclusion criteria
. Diagnosed with a severe or unstable medical illness that precludes safe participation in the study as per study physician, including contraindications to propranolol administration such as asthma, diabetes, arrhythmia or congestive heart failure
. Diagnosed with psychotic disorder or bipolar disorder
. The use of alcohol abstinence medications within the past month
. Current moderate or severe substance use disorder (excluding alcohol, cannabis, tobacco and caffeine)
. A basal systolic blood pressure \< 100 mm Hg or basal heart rate \< 55 beats/minute
. Pregnant or breastfeeding women
. Individuals with known hypersensitivity to propranolol
. Individuals with current use of medication that might interact adversely with propranolol such as anti-arrhythmic medication or calcium channel blockers