In short
Currently, there are 3 clinical trials investigating new treatment approaches for drug use disorder. These studies are taking place in Cyprus and Sweden, and focus on improving recovery outcomes for people with opioid use disorder by testing medications like daridorexant, ketamine, and long-acting buprenorphine formulations.
Clinical trial locations
- Cyprus
- Sweden
Study of daridorexant and buprenorphine combination treatment for patients with opioid use disorder
This study is being conducted in Sweden and examines whether adding a sleep medication called daridorexant to standard buprenorphine treatment can help people recovering from opioid dependence. The trial aims to see if improving sleep quality might help reduce the use of illegal substances and support recovery.
Who can participate: The study is looking for adults between 20 and 65 years old who have moderate-to-severe opioid use disorder that has lasted at least one year. Participants can either be new to treatment or currently taking buprenorphine under the tongue or inside the cheek. You need to be able to speak and read Swedish and willing to provide informed consent to join.
Who cannot participate: The study excludes people with severe mental health conditions like schizophrenia, bipolar disorder, or severe depression. You also cannot join if you have a history of seizures, are pregnant or planning pregnancy, have severe liver disease, or have untreated sleep apnea. Those taking medications that might interact with the study drug or using other sleep medications that cannot be stopped are also excluded.
What the study involves: The research focuses on testing whether daridorexant, when combined with buprenorphine, can help reduce substance use over a 13-week period. Participants will receive either daridorexant or placebo tablets while continuing their buprenorphine treatment, which may be given as injections under the skin or as tablets under the tongue. Each week, you will provide urine samples and complete questionnaires about cravings, withdrawal symptoms, and sleep quality. Monthly assessments will track substance-related issues and daily functioning.
Medications being tested: Daridorexant works by blocking orexin receptors in the brain, affecting sleep-wake cycles and potentially reducing cravings for illicit substances. Buprenorphine is a well-established medication for treating opioid dependence that helps reduce withdrawal symptoms and cravings. In this trial, it is used in a long-acting form given as an injection that releases the medication slowly over time.
Study on Ketamine to Prevent Relapse in Patients with Opioid Use Disorder
This clinical trial in Cyprus is exploring whether ketamine, a medication typically used for pain relief and anesthesia, can help prevent relapse in people recovering from opioid use disorder. The study examines whether ketamine can help people stay off opioids for longer periods and reduce their cravings.
Who can participate: Adults between 18 and 65 years old who are enrolled in an ongoing care program for opioid or heroin use disorder can participate. You must have a score of 10 or more on the PHQ-9 questionnaire, which indicates symptoms of depression, and be actively participating in treatment for opioid use.
Who cannot participate: The study excludes people outside the specified age range, those without an opioid use disorder diagnosis, and individuals considered part of vulnerable populations. You cannot join if you are pregnant or breastfeeding, have unstable mental health disorders, have allergies to ketamine or similar drugs, or are currently participating in another clinical trial. Those with medical conditions or taking medications that could interfere with the study are also excluded.
What the study involves: The trial lasts up to six weeks and examines whether ketamine can help prolong abstinence from opioids, reduce cravings, and improve mood during recovery. Participants receive ketamine through an intravenous infusion directly into a vein. Regular monitoring tracks changes in mood, cravings, and overall mental health. The study also aims to identify biological markers that might predict when someone is at risk of relapsing.
Medication being tested: Ketamine is administered intravenously and works by blocking NMDA receptors in the brain. This mechanism may help reduce cravings and prolong abstinence from opioids. While ketamine is primarily known as an anesthetic, researchers are investigating its potential to help prevent relapse in individuals recovering from opioid addiction.
Study on Long-Term Effects of Buprenorphine in Adults with Opioid Use Disorder
This Swedish study examines the long-term effects of SUBLOCADE, a long-acting form of buprenorphine given as a monthly injection. The research assesses how well this treatment helps adults manage opioid use disorder over several years.
Who can participate: Adults aged 18 and over who plan to continue receiving SUBLOCADE injections can join. You must have either started treatment with SUBLOCADE for opioid use disorder within the last 3 months, or completed a previous SUBLOCADE study and received your last dose within 3 months before the baseline visit. You need to sign an informed consent form agreeing to participate.
Who cannot participate: The study excludes people without an opioid use disorder diagnosis, those outside the specified age range, and individuals considered part of vulnerable populations who might need special protection or care. You also cannot participate if you do not meet other specific health criteria set by the study, such as having medical conditions that might interfere with the research.
What the study involves: The research monitors participants over several years to assess long-term outcomes of SUBLOCADE treatment. The medication is available in two dosages: 300 mg and 100 mg, given as monthly injections under the skin. The study evaluates whether participants achieve remission, meaning they no longer show symptoms of the disorder, and tracks the time it takes to reach this state. Researchers monitor for any opioid use, overdose incidents, and reasons for stopping treatment. The study is expected to conclude by August 31, 2027.
Medication being tested: SUBLOCADE is designed to release buprenorphine slowly over a prolonged period, helping to reduce cravings and withdrawal symptoms associated with opioid dependence. As a partial opioid agonist, it binds to opioid receptors in the brain while providing a safer alternative to full opioid agonists, minimizing the risk of misuse and overdose. This supports individuals in maintaining stability and avoiding relapse during their recovery journey.
Summary
The three ongoing clinical trials for drug use disorder focus specifically on opioid use disorder, reflecting the significant public health challenge posed by opioid dependence. Two of the three trials are taking place in Sweden, while one is being conducted in Cyprus, suggesting particular research interest in Nordic and Mediterranean regions.
A notable pattern is the focus on combining established treatments with novel approaches. Two studies examine buprenorphine-based treatments: one combining it with daridorexant to address sleep problems that may contribute to relapse, and another studying the long-term effectiveness of the monthly injectable formulation SUBLOCADE. The third trial explores ketamine, a medication more commonly associated with anesthesia, as a potential intervention to prevent relapse by reducing cravings and improving mood.
These trials share common goals of reducing relapse rates, managing cravings, and improving quality of life for people in recovery. The studies vary in duration from six weeks to several years, offering insights into both short-term interventions and long-term maintenance approaches. Together, they represent innovative efforts to improve treatment outcomes for people struggling with opioid dependence.
