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New treatment option for Alcohol Use Disorder
Official title Involvement of the Septal Nuclei of the Human Brain in Alcohol Use Disorder
ClinicalTrials.gov ID: NCT06866379
What this study is testing
- What it's testing
- Alcohol activates reward systems in different brain areas, i.e., the nucleus accumbens, dorsal striatum, extended amygdala, and prefrontal cortex. These areas are all part of the reward neurocircuitry, which plays an important role in the development of addiction.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 65
You may be able to join if
- Diagnosed with alcohol use disorder (AUD) according to DSM-5, and alcohol dependence according to ICD-10
- An Alcohol Use Disorder Identification Test (AUDIT) score ≥ 15
- At least six heavy drinking days for the last 30 days, measured with the Time Line Follow Back (TLFB) method
You likely can't join if
- Diagnosis of schizophrenia spectrum disorder, paranoid psychosis, bipolar disorder, or mental retardation
- Previous or current substance use disorder other than AUD and nicotine use disorder
- History of alcohol withdrawal seizures within the past 5 years
- Alcohol withdrawal symptoms defined as a CIWA-Ar score \> 9 at screening or at the fMRI session
- Treatment with chlordiazepoxide or other benzodiazepine within the past 30 days
- Other pharmacological treatment for AUD within the past 30 days
See the full eligibility criteria
- Diagnosed with alcohol use disorder (AUD) according to DSM-5, and alcohol dependence according to ICD-10
- An Alcohol Use Disorder Identification Test (AUDIT) score ≥ 15
- At least six heavy drinking days for the last 30 days, measured with the Time Line Follow Back (TLFB) method
- Diagnosis of schizophrenia spectrum disorder, paranoid psychosis, bipolar disorder, or mental retardation
- Previous or current substance use disorder other than AUD and nicotine use disorder
- History of alcohol withdrawal seizures within the past 5 years
- Alcohol withdrawal symptoms defined as a CIWA-Ar score \> 9 at screening or at the fMRI session
- Treatment with chlordiazepoxide or other benzodiazepine within the past 30 days
- Other pharmacological treatment for AUD within the past 30 days
- Treatment with GLP-1 analogues within the last 6 months
- Urine tests positive for psychoactive drugs (cocaine, amphetamine, TCH, methadone, opioids, and benzodiazepines) at screening
- DUDIT score ≥ 2/6 for females/males
- Contraindications for undergoing an fMRI scan (magnetic implants, metal splinters, pacemaker, claustrophobia, etc.)
- Females of childbearing potential who are either pregnant, breastfeeding or have the intention of becoming pregnant within the next month or are not using contraception appropriate for participating in a clinical study
- Pregnancy (positive urine pregnancy test)
- Unable to speak or understand Danish
- Any condition that the investigator feels would interfere with trial participation
The study team makes the final eligibility decision.
Where it's taking place
- Frederiksberg, Denmark
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, 30 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frederiksberg, Denmark. 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.