Phase 2 PTSD Trial, Recruiting

Written by an AI model from the 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 at least 18 years old.
• People who have opioid use disorder and are taking daily oral methadone (180 mg or less) or sublingual buprenorphine (24 mg or less), and whose treatment has been considered stable for at least 3 months by their prescriber or medical records.
• People who can speak and read English fluently.
• People who are able to swallow pills.
• People who agree to have study visits recorded, including therapy sessions and certain assessments.
• People who can provide a contact person (such as a relative, spouse, or close friend) who can be reached by the research team if needed.
• People who agree to tell the research team about any new medical conditions or procedures within 48 hours of them occurring.
• People who are able to become pregnant must have a negative pregnancy test at the start of the study and before each experimental session, and must agree to use an approved form of birth control for at least 10 days after the last experimental session (confirm with trial site for the full list of accepted methods).
• People who agree to certain lifestyle changes described in the study protocol (confirm with trial site for details).
• People who have been diagnosed with moderate to severe PTSD (post-traumatic stress disorder) that has lasted at least 6 months, confirmed by a standard diagnostic assessment.
• People who have been diagnosed with opioid use disorder, confirmed at the screening visit.
• People who have had PTSD symptoms for at least 3 months and have scored 40 or higher on a standard PTSD symptom checklist in the past month.
• People who have high blood pressure that is well managed with medication, provided additional heart health screening shows no underlying cardiovascular disease.
• People who have had hepatitis C that has previously been assessed and treated as needed, and are currently without symptoms.
• People who score 28 or higher on a detailed PTSD assessment (CAPS-5) at the baseline visit.
• People who have mild or early-remission moderate alcohol or cannabis use disorder, under specific conditions (confirm with trial site for details).
• People who have type 2 diabetes that is stable and well managed, provided additional heart health screening rules out cardiovascular disease and the study doctor approves.
• People who have an underactive thyroid (hypothyroidism) that is being treated with stable thyroid replacement medication.
• People who have a history of or current glaucoma, provided an eye specialist (ophthalmologist) approves their participation.

Who may not be able to join:

• People who are not able to give informed consent.
• People who are currently prisoners.
• People who, in the opinion of the research team, are likely to be re-exposed to the traumatic event that caused their PTSD, or who lack social support or a stable living situation.
• People who have any current health concern that the research team believes could interfere with their participation.
• People whose heart test (ECG) shows a certain irregular heart rhythm reading (QTc greater than 460 milliseconds) at screening, or for methadone users, within 72 hours before each treatment session.
• People who have received electroconvulsive therapy (ECT, a brain stimulation treatment) within 12 weeks before enrolling.
• People who have ever been diagnosed with, or currently have, a primary psychotic disorder, bipolar disorder type 1, or dissociative identity disorder.
• People who currently have an eating disorder that involves purging.
• People who currently have severe depression with psychotic features.
• People who have moderate or severe alcohol or cannabis use disorder that is not in early remission, or severe alcohol or cannabis use disorder within the past 6 months.
• People who have an active substance use disorder involving illicit drugs (other than cannabis or opioids) or misuse of prescription drugs within the past 3 months.
• People who were diagnosed with moderate or severe cannabis use disorder in the past 6 months and have not reduced their use to a mild level or stopped before enrolling (confirm with trial site for details).
• People who have certain personality disorders in a specific cluster (paranoid, schizoid, or schizotypal types), confirmed by a structured clinical interview.
• People who the research team assesses as having a high risk of a serious emotional or behavioural reaction, based on clinical evaluation.
• People who are currently assessed as being at serious risk of suicide (note: a past history of suicide attempts is not an automatic exclusion — confirm with trial site).
• People who have a medical history of any condition that could make it harmful to receive a drug that raises blood pressure and heart rate.
• People who have uncontrolled high blood pressure (readings of 140/90 mmHg or higher on three separate occasions).
• People who have a history of a serious irregular heart rhythm (ventricular arrhythmia), except for occasional minor irregular beats with no heart disease present.
• People who have had certain other heart rhythm problems within the past 12 months, except for occasional minor irregular beats with no heart disease present.
• People who have additional risk factors for a specific dangerous heart rhythm condition called Torsade de pointes (for example, heart failure, low potassium levels, or a family history of Long QT Syndrome).
• People who need to take medications that affect heart rhythm (QT interval) during the experimental sessions.
• People who have active liver disease or significantly elevated liver enzyme levels.
• People who have a history of abnormally low sodium levels or dangerously high body temperature.
• People who weigh less than 48 kilograms (approximately 106 pounds).
• People who are pregnant, or who are able to become pregnant and are not using an effective form of birth control.

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