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 who are willing and able to give written consent to take part in the study.
• People who can read, write, and communicate clearly with the research team, and are able to follow all study instructions.
• Men or women between 18 and 70 years of age at the time of screening.
• People who are generally in good health, as confirmed by medical history, physical examination, heart tests, and blood and urine tests.
• People with an alcohol use disorder (AUD) who have been formally diagnosed according to standard diagnostic criteria (DSM-5), confirmed by the study's lead researchers.
• People with AUD who drink heavily at levels meeting specific thresholds — for men, more than 14 drinks per week and more than 4 drinks on at least two days per week; for women, more than 7 drinks per week and more than 3 drinks on at least two days per week — with this pattern occurring over a continuous 30-day period within the 90 days before entering the study.
• People with post-traumatic stress disorder (PTSD) who have been formally diagnosed according to standard diagnostic criteria (DSM-5), confirmed by the study's lead researchers.
• People who have experienced a traumatic event but have not been diagnosed with PTSD may also be considered for inclusion as a comparison group (confirm with trial site).
• Healthy volunteers with no current or past diagnosis of AUD or other significant substance use disorder, who drink fewer than 5 alcoholic drinks per week and have no heavy drinking days in the last 30 days. People who have experienced a traumatic event without a PTSD diagnosis may also qualify as healthy controls for part of the study (confirm with trial site).
• People whose kidney and liver function fall within normal ranges for their age and sex — though mildly elevated liver enzymes in people with AUD may be permitted at the study doctor's discretion.

Who may not be able to join:

• People with a significant current medical condition affecting the nervous system, heart, hormones, kidneys, liver, or thyroid that could affect study results (note: mildly elevated liver enzymes in people with AUD are not automatically disqualifying).
• People with a past or current neurological condition affecting the brain, such as multiple sclerosis, stroke, brain tumours, traumatic brain injury involving loss of consciousness, or a seizure disorder.
• People with a current serious psychiatric condition, a severe substance use disorder (other than alcohol or tobacco), or a past or current history of psychotic symptoms (such as hallucinations or delusions).
• People who have regularly used prescription, psychoactive, or herbal medicines in the past 6 months (such as antidepressants, antipsychotics, or anti-anxiety medications) that could affect study results. The trial site will not ask participants to stop any medication in order to take part. People regularly taking certain drug-transport inhibitors (P-gp and BCRP inhibitors) will not be eligible (confirm with trial site).
• People who are currently pregnant or breastfeeding.
• People who have donated blood within eight weeks before the study starts.
• People with a history of a bleeding disorder, or who are currently taking blood-thinning medications (such as Coumadin, Heparin, Pradaxa, or Xarelto).
• People who are not able to safely stop or pause the use of aspirin or other anti-inflammatory pain medications (NSAIDs).
• People who are unable to have an MRI scan, including those with pacemakers, certain implants, non-removable metal piercings, claustrophobia, or metal fragments in the body or head, or people who have worked extensively with metal materials (such as welders or sheet metal workers).
• People who have participated in other research involving radiation exposure within the past year, where the combined exposure would exceed recommended yearly limits for healthy volunteers.
• People who have been, or expect to be, exposed to radiation in their workplace within the past year, where the combined total with the study's radiation exposure would exceed recommended safety limits.
• People who have any condition that, in the opinion of the study team, would prevent them from safely completing the study.
• People with a history of complicated alcohol withdrawal, including delirium tremens, seizures related to withdrawal, or hospitalisation for withdrawal.
• People with a withdrawal symptom score (CIWA score) of 8 or higher at the time of entry into the study or on the day of scanning (confirm with trial site).
• People who, in the study doctor's opinion, would not be able to safely avoid drinking alcohol overnight before their study visits.
• People with a significant history of repeated alcohol withdrawal, defined as four or more medically supervised detoxifications in the past five years.

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