Ongoing Clinical Trials for Drug Dependence
There are currently 9 clinical trials investigating new treatments for drug dependence, including studies on benzodiazepine, opioid, cocaine, cannabis, and GHB (gamma-hydroxybutyrate) dependence. These trials are taking place across Europe, testing medications such as baclofen, dexamphetamine, oxytocin, and N-acetylcysteine to help people overcome various forms of substance dependence.
Clinical trial locations
- Austria
- Belgium
- France
- Netherlands
- Norway
- Study of diazepam and oxazepam in patients with benzodiazepine and opioid dependence who are receiving opioid agonist therapy
- Study on Dexamfetamine for Adults with Amphetamine and Opioid Dependence Undergoing Opioid Treatment
- Study of Intranasal Oxytocin Treatment for Patients with Benzodiazepine Withdrawal Symptoms: A Comparison with Placebo during Diazepam Dose Reduction
Study of diazepam and oxazepam in patients with benzodiazepine and opioid dependence who are receiving opioid agonist therapy
This trial is designed for people who have dependence on both benzodiazepines and opioids while receiving opioid agonist therapy. To participate, you must be at least 18 years old and have been dependent on benzodiazepines for at least 5 years, using them 5-7 days per week. Your daily benzodiazepine use must be equivalent to 15 mg of diazepam or higher. You must also have previously tried to stop using benzodiazepines through treatment programs but were not successful.
People who cannot participate include those under 18 or over 65 years old, pregnant or breastfeeding women, individuals with severe liver disease or breathing problems, and those with active suicidal thoughts or severe mental health conditions requiring immediate treatment.
The study compares two treatment approaches over 24 weeks. One group receives a stable dose of either diazepam or oxazepam for the entire period, while the other group has their dose gradually reduced over 20 weeks. The main goal is to see which approach works better at reducing the use of unauthorized benzodiazepines. Throughout the study, participants are monitored for mental health symptoms, quality of life, and overall satisfaction with treatment. Regular urine tests help track substance use.
Both medications being tested – diazepam and oxazepam – are benzodiazepines that help calm the central nervous system and manage withdrawal symptoms in people who are dependent on these medications.
Study on Baclofen for Inpatient Detoxification in Patients with GHB Use Disorder
This study focuses on helping people with GHB use disorder, a condition involving excessive use of gamma-hydroxybutyrate. To join, you must have a formal diagnosis of GHB use disorder, need inpatient treatment for detoxification, use more than 50ml of GHB per day, and be over 18 years old.
The trial tests whether adding baclofen to standard treatment can reduce the need for pharmaceutical GHB during the detoxification process. Baclofen is typically used to treat muscle spasms but is being studied here to see if it can help manage withdrawal symptoms and reduce cravings during detoxification.
Participants receive either baclofen tablets or a placebo, along with sodium oxybate as part of their detoxification regimen. The study monitors how much pharmaceutical GHB each person needs at the end of their treatment, which helps researchers understand whether baclofen is effective in making the detoxification process easier and more comfortable.
Study on Dexamfetamine for Adults with Amphetamine and Opioid Dependence Undergoing Opioid Treatment
This trial examines whether dexamfetamine can help adults who are dependent on both amphetamines and opioids. To be eligible, you must be between 18 and 65 years old, have been dependent on amphetamines for at least 3 years, use them at least 4 days a week, and be receiving stable medication for opioid dependence.
You cannot participate if you are outside the age range or are part of a vulnerable population unable to provide informed consent.
The study lasts 12 weeks, during which participants receive either dexamfetamine or a placebo in tablet form. The main goal is to determine whether taking dexamfetamine daily can reduce the use of illegal amphetamines in people who are also being treated for opioid dependence. Throughout the trial, researchers monitor psychological well-being, quality of life, and how well participants stick to their opioid treatment. Regular urine tests check for illicit amphetamine use.
Dexamfetamine works by increasing levels of certain brain chemicals like dopamine and norepinephrine, which can help reduce cravings and improve focus.
Study of Intranasal Oxytocin Treatment for Patients with Benzodiazepine Withdrawal Symptoms: A Comparison with Placebo during Diazepam Dose Reduction
This study explores whether oxytocin nasal spray can help people manage withdrawal symptoms when stopping benzodiazepines. To participate, you must be between 18 and 65 years old, currently taking benzodiazepines equivalent to 20-80 mg of diazepam daily, and require inpatient withdrawal treatment.
You cannot join if you are pregnant or breastfeeding, have severe heart, kidney, or liver problems, have other severe psychiatric disorders, or have alcohol dependence or use of other psychoactive substances. People with nasal conditions that could interfere with nasal spray delivery are also excluded.
The treatment involves using either oxytocin nasal spray or placebo spray daily for 21 days while gradually reducing your diazepam dose. The study measures withdrawal symptoms daily using a standardized assessment tool. Researchers also evaluate anxiety, depression, and sleep quality throughout the treatment period.
Oxytocin is a naturally occurring hormone that may help regulate anxiety and stress responses, potentially making the withdrawal process easier. The study aims to determine if this approach can reduce the discomfort people experience when stopping benzodiazepine medications.
Study on Baclofen for Inpatient Detoxification in Patients with GHB Use Disorder
This trial, similar to another GHB study, focuses on testing whether baclofen can help reduce the need for pharmaceutical GHB during detoxification. To join, you must have a diagnosis of GHB use disorder, need inpatient detoxification, use more than 50ml of GHB daily, and be over 18 years old.
People who cannot participate include those not diagnosed with GHB use disorder, those outside the study’s age range, pregnant or breastfeeding women, individuals with other medical conditions that might make participation unsafe, and those currently in another clinical trial.
Participants receive baclofen tablets (either 25 mg or 10 mg) along with sodium oxybate. The study closely monitors how medication dosages need to be adjusted based on each person’s response and any side effects. The main focus is measuring how much pharmaceutical GHB is needed at the end of the treatment period.
Baclofen works by activating specific receptors in the brain that help decrease nervous system activity, which may help relieve withdrawal symptoms and make detoxification more manageable.
Study on Baclofen for Reducing Benzodiazepine Use in Patients with Benzodiazepine Dependence
This French trial tests whether baclofen can help people reduce their benzodiazepine use. To be eligible, you must be between 18 and 65 years old and have benzodiazepine use disorder according to specific diagnostic criteria. Your average daily dose should be between 50 and 200 mg of diazepam equivalent, you must have been using benzodiazepines for more than 12 weeks, and you must have tried unsuccessfully to stop before. Women who can become pregnant must use effective birth control and have negative pregnancy tests.
You cannot participate if you have certain psychiatric disorders, addiction-related issues not specified in the trial, or are outside the age range.
Participants are randomly assigned to receive either baclofen or a placebo for a period lasting until Day 62/64. The study monitors various aspects of health, including withdrawal severity, cravings, anxiety, depression, sleep quality, and overall quality of life. The main goal is to compare benzodiazepine use before and after treatment to see if baclofen helps people reduce their doses more effectively than placebo.
Study on How N-acetylcysteine Helps Treat Cannabis Addiction in Adults
This Belgian study examines whether N-acetylcysteine can help treat cannabis dependence. To participate, you must be male, between 18 and 45 years old, have a current diagnosis of cannabis dependence, be detoxified and abstinent from cannabis for more than 1 week, and speak Dutch as your primary language.
You cannot join if you are not dependent on cannabis or are under 18 years old.
The trial involves taking either N-acetylcysteine (600 mg oral solution) or a placebo for 14 days. Researchers monitor participants to see how the medication affects cannabis dependence and helps reduce cravings.
N-acetylcysteine works by replenishing glutathione, an antioxidant that helps reduce oxidative stress in the brain, and by modulating glutamate levels, which may influence addictive behaviors. This medication is usually used as a mucolytic agent but is being explored for its potential in addiction treatment.
Study on Sustained-Release Dexamphetamine and Piracetam for Patients with Moderate to Severe Cocaine Use Disorder and Opioid Dependence
This Dutch trial studies the effectiveness of sustained-release dexamphetamine in helping people with both cocaine use disorder and opioid dependence. To participate, you must be receiving opioid treatment with oral methadone, have moderate or severe cocaine use disorder, have used cocaine regularly in the past month primarily by snorting, inhaling, or injecting, want to reduce or stop cocaine use, and be able to visit the treatment center twice a week.
You cannot join if you do not have cocaine use disorder, are not receiving oral methadone for opioid dependence, or are not within the study’s age range.
The treatment involves taking sustained-release dexamphetamine tablets or placebo for 24 weeks, with doses individually adjusted up to a maximum of 90 mg per day. The study monitors the number of days participants abstain from cocaine use in the final four weeks of treatment and assesses overall health status, including physical, mental, and social well-being. Safety is tracked through regular checks of vital signs like heart rate and blood pressure.
Dexamphetamine works by increasing levels of brain chemicals like dopamine and norepinephrine, which can help improve mood and reduce cravings for cocaine.
Study on the Safety and Feasibility of Intravenous Hydromorphone Hydrochloride for Patients with Opioid Dependence
This Austrian study examines whether intravenous hydromorphone hydrochloride is safe and feasible for treating opioid dependence. To participate, you must be between 20 and 65 years old, have opioid dependence, have been on opioid agonist therapy for at least one year (or using opioids intravenously for at least one year if not on therapy), inject opioids at least 5 times per week, and be willing to follow the study schedule.
You cannot participate if you are not dependent on opioids or are outside the specified age range.
The treatment involves receiving hydromorphone hydrochloride through intravenous injection for up to 12 weeks. The medication comes in different concentrations (10 mg/ml, 20 mg/ml, and 50 mg/ml), and the dosage is determined based on individual needs. The study aims to see if this treatment can be successfully integrated into regular medical practice and whether it helps reduce the use of illegal opioids, improves overall health and social situation, and helps patients stay in treatment longer.
Hydromorphone is an opioid medication that works by binding to opioid receptors in the brain to reduce withdrawal symptoms and cravings associated with opioid dependence.
Summary
These 9 clinical trials represent diverse approaches to treating various forms of substance dependence across Europe. Several notable patterns emerge from this collection of studies.
Norway leads with three trials, focusing primarily on benzodiazepine and amphetamine dependence in people also receiving opioid treatment. The Netherlands also contributes three studies, concentrating on GHB detoxification and cocaine use disorder. France, Belgium, and Austria each contribute one trial, addressing benzodiazepine dependence, cannabis addiction, and opioid dependence respectively.
Baclofen appears in three separate trials, being tested for reducing benzodiazepine use and aiding GHB detoxification. Dexamphetamine is tested in two trials for amphetamine and cocaine dependence. Other medications being investigated include oxytocin for benzodiazepine withdrawal, N-acetylcysteine for cannabis dependence, and hydromorphone for opioid dependence.
Many trials focus on people with multiple dependencies, particularly those combining opioid dependence with other substance use disorders. This reflects the real-world complexity of addiction treatment, where people often struggle with more than one substance at the same time. The studies generally last between 12 and 24 weeks and include careful monitoring of both effectiveness and safety throughout the treatment period.
