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New treatment option for Alcohol Addiction
Official title A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol Dependence
ClinicalTrials.gov ID: NCT06845124
What this study is testing
What is Cannabidiol capsules?
Cannabidiol capsules is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for alcohol addiction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Alcohol addiction (AD) is a chronic relapsing disorder with currently limited pharmacological treatment options. Alcohol craving, a hallmark symptom of AD that drives relapse in patients, is only insufficiently treated by existing medication.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age between 18 and 70 years
- Patients meeting the diagnosis of an alcohol dependence according to the ICD-10
- Patients reporting alcohol craving as symptom of AD according to the ICD10 symptom definition
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrollment in the study)
You likely can't join if
- Current psychotic or bipolar disorder or current severe depressive episode with suicidal ideations
- Current treatment with any of the following substances: Any investigational medicinal product, Opioid-containing Analgesics, Anti-obesity drugs...
- Positive drug screening (amphetamines/ecstasy, opiates, cocaine, barbiturates)
- Pregnancy, lactation or breastfeeding
- Current severe somatic comorbidities: severe liver cirrhosis [CHILD B or C] or epilepsy determined by medical history
- Patients with elevated transaminase levels (AST or ALT) above three times the upper limit normal (ULN) value with elevated bilirubin levels above...
See the full eligibility criteria
- Age between 18 and 70 years
- Patients meeting the diagnosis of an alcohol dependence according to the ICD-10
- Patients reporting alcohol craving as symptom of AD according to the ICD10 symptom definition
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrollment in the study)
- Consent to random assignment
- For women with childbearing potential (WOCBP) and males with partners with CBP, use of a highly effective birth control method until one month after last IMP administration (see Appendix 1) and negative pregnancy test
- Current psychotic or bipolar disorder or current severe depressive episode with suicidal ideations
- Current treatment with any of the following substances: Any investigational medicinal product, Opioid-containing Analgesics, Anti-obesity drugs, Anticonvulsants, Opioid-containing Antidiarrheal Agents, Antineoplastics...
- Positive drug screening (amphetamines/ecstasy, opiates, cocaine, barbiturates)
- Pregnancy, lactation or breastfeeding
- Current severe somatic comorbidities: severe liver cirrhosis [CHILD B or C] or epilepsy determined by medical history
- Patients with elevated transaminase levels (AST or ALT) above three times the upper limit normal (ULN) value with elevated bilirubin levels above twice the ULN value
- History of hypersensitivity to the investigational medicinal product CBD and/or Naltrexone (trade names: Adepend, Naltrexon-Hcl neuraxpharm, Naltrexonhydrochlorid Accord) or to any drug with similar chemical structure...
- Participation in other clinical trials or observation period of competing clinical trials, respectively.
- Acute suicidal tendency or acute endangerment of self and others
The study team makes the final eligibility decision.
Where it's taking place
- Wiesloch, Baden-Wurttemberg, Germany
- Mannheim, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wiesloch, Baden-Wurttemberg, Germany; Mannheim, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.