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 aged 18 to 65 years old at the time of giving consent to participate
• People who have been diagnosed with PTSD according to standard diagnostic guidelines (DSM-5)
• People whose PTSD symptoms reach a minimum required severity level, based on a standard clinical assessment tool called the CAPS-5 (a score of at least 26)
• People whose current medications and/or therapy have been stable for at least 2 months, as determined by the trial doctor
• People who are willing to stay on their current doses of other psychiatric medications for the whole trial
• People who are willing and able to stop any medications that cannot safely be taken alongside the trial drug (HB-1), as determined by the trial doctor
• People who are fluent in English
• People who are willing to take the trial drug, HB-1
• People who are willing and able to give informed consent, attend scheduled visits, and follow all study procedures
• Women who cannot become pregnant (due to surgery or being at least 2 years past menopause), or who agree to use an accepted form of contraception (such as an intrauterine device, barrier method with spermicide, condoms, hormonal contraception, or abstinence) for the full duration of the study (confirm with trial site regarding abstinence requirements)
• Men who are sterile or who agree to use condoms with spermicide for the duration of the study and for 4 months after the last dose of the trial drug
• People in same-sex relationships are exempt from birth control requirements, but must agree to follow the requirements if they do enter a heterosexual relationship during the trial
• Women of childbearing potential who have a negative pregnancy test at screening, taken within 7 days before the first dose of the trial drug

Who may not be able to join:

• People with any ongoing illness, condition, or treatment that the trial doctor or sponsor believes could interfere with the study or pose an unacceptable risk
• People currently being treated with benzodiazepines (such as alprazolam, diazepam, clonazepam, or lorazepam) or opiates (such as codeine or morphine), confirmed by interview and urine testing
• People currently taking medications that are known to interact significantly with either telmisartan or verapamil (the two components of HB-1) — this includes a wide range of drugs such as certain cholesterol medications, heart rhythm medications, lithium, carbamazepine, rifampin, cyclosporin, and several others (confirm full list with trial site)
• People diagnosed with severe substance use disorder, obsessive-compulsive disorder (OCD), bipolar I or II disorder, a psychotic disorder, or borderline personality disorder
• People with active thoughts of suicide or self-harm reaching a certain level of severity on a standard scale (C-SSRS score of 4 or above at screening), or who have made a serious suicide attempt in the past 3 months
• People who have had serious uncontrolled heart problems in the 6 months before screening, including severely uncontrolled high or low blood pressure, unstable chest pain, heart attack, or stroke
• People with significant abnormalities on a heart tracing (ECG) at screening
• People whose liver is not functioning adequately, based on specific blood test results
• People whose kidneys are not functioning adequately, based on specific blood test results
• People with any other significant abnormal results on standard laboratory tests, as determined by the trial doctor
• People who are already taking telmisartan, verapamil, or both
• People who have a documented reason they cannot take telmisartan or verapamil, such as a prior allergic reaction to either drug, Duchenne's muscular dystrophy, or myasthenia gravis
• People who are pregnant or breastfeeding
• People currently participating in another clinical trial, or who have participated in one within the past 3 months
• People whose urine test shows exposure to substances that could interfere with HB-1 testing, as determined by the trial doctor

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