Clinical Trials for Substance Use Disorder
There are currently 2 ongoing clinical trials investigating new treatments for substance use disorder. These studies are exploring the use of ketamine for individuals with depression and alcohol dependence, and oxytocin for preventing drug relapse in people dependent on substances like heroin or cocaine. The trials are taking place in Norway and Italy.
Clinical trial locations
- Italy
- Norway
Study on Ketamine and Midazolam for Adults with Depression and Alcohol Use Disorder
This clinical trial, being conducted in Norway, is investigating whether ketamine can help adults who are struggling with both depression and alcohol dependence. The study focuses on people who are receiving inpatient addiction therapy at University Hospital of North Norway.
Who can participate: To join this study, you must be between 18 and 65 years old and have at least moderate depression without psychotic features. Your primary substance use problem must be alcohol dependence, and you need to be admitted to the hospital for inpatient addiction therapy. Depression is a mental health condition that causes persistent feelings of sadness and loss of interest, while alcohol dependence means having a strong need to drink alcohol and difficulty controlling its use.
Who cannot participate: You cannot join if you do not have both depression and alcohol use disorder, if you are outside the specified age range, or if you are considered part of a vulnerable population who may have limited ability to protect their own interests.
What the trial involves: Participants will receive treatment through intravenous infusion, which means the medication is given directly into a vein. The study uses two medications: ketamine (in a product called Ketalar) and midazolam hydrochloride (in Midazolam Accord). The trial compares the effects of ketamine with a placebo to see if there is a meaningful difference in how depression symptoms improve. Researchers will also monitor changes in alcohol cravings and consumption, as well as any side effects that occur during treatment.
Study goals: The main goal is to measure changes in depression symptoms using a scale called MADRS, from the start of treatment to within three days after the final session. The study also looks at changes in alcohol craving, alcohol consumption, brain function, and the frequency and severity of any adverse reactions. Follow-up assessments continue for up to six months after treatment to see how long participants can maintain reduced alcohol consumption.
The investigational drug: Ketamine is being studied for its potential to rapidly reduce depression symptoms in adults with alcohol use disorder. It works by blocking receptors in the brain called NMDA receptors, which are involved in mood regulation. Ketamine has gained attention for its quick-acting antidepressant effects, especially when traditional treatments have not worked.
Study on Oxytocin and Sodium Chloride for Preventing Drug Relapse in Individuals with Substance Use Disorder
This clinical trial in Italy is testing whether a nasal spray containing oxytocin can help reduce drug cravings and prevent relapse in people with substance use disorder, particularly those dependent on drugs like heroin or cocaine.
Who can participate: You can join this study if you are between 18 and 55 years old and have been diagnosed with substance use disorder according to standard medical criteria. This means a doctor has determined that you have a pattern of drug use that leads to significant problems or distress. You must be male or a female who is not pregnant or breastfeeding, be willing to give informed consent, understand Italian, and be able to provide an identity document.
Who cannot participate: You cannot join if you are outside the age range, do not have a diagnosed substance use disorder, or are part of a vulnerable population that may need special protection.
What the trial involves: Participants will use a nasal spray called Syntocinon, which contains oxytocin and sodium chloride, for four weeks. Oxytocin is a hormone naturally produced in the body that plays a role in social bonding and reducing stress. Throughout the study, researchers will monitor how your cravings change and whether you are able to stay away from drug use. On days 7 and 30, you will report your cravings after being exposed to certain cues. On day 30, you may also have a brain scan called fMRI to see how your brain responds to the treatment.
Study goals: The main purpose is to evaluate whether Syntocinon can reduce cravings for drugs and prevent relapse. You will also participate in tasks designed to measure your social and emotional responses, such as viewing pictures and engaging in interactive activities. These tasks help researchers understand if the treatment affects how you interact with others and manage your emotions. Follow-up assessments at 3 and 6 months after treatment will track how long you can maintain abstinence from drug use.
The investigational drug: Syntocinon is a synthetic form of oxytocin delivered as a nasal spray. It is being studied for its potential to reduce cravings by influencing the brain’s reward system, which may alter the mechanisms associated with social reward and help reduce the desire for drug use.
Summary
Currently, there are 2 clinical trials underway for substance use disorder, with one study in Norway and one in Italy. The Norwegian trial focuses specifically on people dealing with both depression and alcohol dependence, testing whether ketamine can provide rapid relief from depressive symptoms while supporting addiction therapy. The Italian trial targets a broader range of substance dependencies, including heroin and cocaine, and explores whether oxytocin can help prevent relapse by reducing cravings.
Both studies represent different approaches to treating substance use disorder. The ketamine trial uses intravenous medication and focuses on dual diagnosis patients in an inpatient setting, while the oxytocin trial uses an easy-to-administer nasal spray and includes brain imaging to understand how the treatment works. These trials reflect ongoing efforts to find new treatment options for people struggling with addiction, particularly when traditional approaches have not been sufficient.
