3 Clinical Trials for Various Conditions
The investigators propose an imaging study to investigate the neurobiological effects of CBD (vs placebo) in participants with opioid use disorder who are maintained on methadone. The purpose of the study is to determine the neural circuits and transmitters associated with the effects of CBD on to reduce craving and anxiety. The neuroimaging will be conducted in participants immediately following their first administration of CBD (800mg or placebo) and one week after the last administration (3 daily doses). This CBD administration protocol was shown in previous studies by the investigators to reduce craving and anxiety in abstinent heroin users.
This is a multicenter, randomized clinical comparative effectiveness trial (RCT) in which patients with untreated OUD presenting to a Northwell Health Emergency Department (ED), NYULH-Brooklyn, NYULH-Tisch, and Bellevue Hospital will be randomized (1:1) to be managed clinically through either a standard ED visit or an extended visit through ED observation (EDOU).
Background: Opioids are medicines that control pain. But they are often misused, which can lead to illness and death. Opioids increase dopamine to the brain, which makes people feel good and often causes them to crave drugs, leading to misuse and addiction. An investigational drug ANS-6637 may lower the dopamine surge and stop opioid craving. Midazolam is a drug approved for anxiety. Researchers want to give the two drugs together and see if ANS-6637 affects midazolam levels, to help understand how ANS-6637 is used in the body. Objective: To study the safety, tolerability, and effects of ANS-6637 taken with and without midazolam. Eligibility: Healthy adults 18 65 years old Design: Participants will be screened with a medical history, physical exam, and blood and heart tests. Participants who can get pregnant will have a pregnancy test. Participants must agree to use 2 types of birth control during the study, if applicable. Participants will stay at the clinic for 10 days. Meals will be provided. Participants will not be allowed to: Leave NIH campus Eat or drink anything with caffeine, alcohol, or certain juices Use any nicotine or related products (including vaping) Use any medicines (including herbal) During the clinic stay, participants will: Fast overnight several times Have blood drawn most days. Twice, a small tube will be inserted in an arm vein for frequent blood samples. Repeat screening tests and answer questions about their mood several times Get midazolam syrup in water on 1 day Take 6 ANS-6637 tablets by mouth on 5 days Take both study drugs on 1 day A few days later, participants will have a follow-up visit to repeat screening tests and answer questions about their mood.