Phase 2 PTSD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People between 18 and 70 years old (any gender)
• People who have been diagnosed with moderate or severe Alcohol Use Disorder (a problematic pattern of drinking) based on a structured clinical interview
• People who want to cut down or stop drinking
• People who have had at least 4 heavy drinking days in the 30 days before screening (defined as 4 or more drinks per day for women, or 5 or more drinks per day for men)
• People who have a current diagnosis of PTSD, or a partial PTSD diagnosis meeting certain specific symptom criteria, confirmed through a clinical assessment tool called the CAPS-5
• People of childbearing potential (male or female) who are willing to use contraception for the whole duration of the trial
• People who can provide at least 2 contact details for locating them during the trial
• People who are able to give voluntary, informed consent to participate
• People who have a stable, reliable place to live

Who may not be able to join:

• People who are currently going through alcohol withdrawal (based on a clinical score above a certain threshold)
• People who have a current diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder type I, significant current thoughts of suicide, any significant suicidal behaviour in the past 12 months, any history of serious suicide attempts that required hospitalisation, or active thoughts of harming others
• People who currently have a severe substance use disorder for any substance other than alcohol or nicotine
• People with a history of severe traumatic brain injury; and people with a mild or moderate brain injury in the past 12 months meeting certain symptom criteria (the principal investigator will determine eligibility in those cases — confirm with trial site)
• People who have experienced a traumatic event in the last 30 days, including through police duty or military service
• People with significantly impaired liver function based on specific blood test results (confirm with trial site for exact thresholds)
• People with other medical conditions that would make safe participation in the study impossible (confirm with trial site)
• People with significant abnormalities in blood tests, including abnormal liver function, blood count, or metabolic results
• People currently taking certain medications that could interact badly with the study drug, including some anti-seizure medications (such as Phenytoin, Carbamazepine, and Depakote), metformin, medications for addiction treatment including alcohol use disorder, certain other medications in the same drug class (such as zonisamide, acetazolamide, dichlorphenamide), and other central nervous system depressants — antidepressants may be permitted if the dose has been stable for at least 4 weeks before screening and remains unchanged during the treatment phase (confirm with trial site)
• People who are pregnant or breastfeeding
• People currently receiving formal treatment for alcohol use disorder, with the exception of 12-step or peer support programs, or psychosocial treatment that started more than 2 months before screening
• People currently receiving methadone treatment or treatment for opioid use disorder
• People who have started psychotherapy for PTSD or another mental health condition within 3 months of screening
• People with a known allergy or sensitivity to the medication topiramate
• People with active legal issues that are likely to result in imprisonment within 12 weeks of starting treatment
• People with significantly reduced kidney function based on a specific blood test result (confirm with trial site for exact threshold)
• People assessed by the investigator as being at high risk of a serious emotional or behavioural reaction, or who are unable to understand the study procedures or consent process — this may include people with serious personality disorders, significant antisocial behaviour, major current life stressors, or very limited social support
• People who have been admitted to a psychiatric hospital in the last 12 months, except for detox or extended emergency department stays

Important: Always verify eligibility with the trial site directly before applying.