Alcohol Use Disorder study: Acamprosate calcium
Official title Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder
ClinicalTrials.gov ID: NCT06269627
What this study is testing
What is Acamprosate calcium?
This is an investigational oral capsule being studied to help people with alcohol use disorder. It is designed to help reduce anxiety and cravings related to alcohol use.
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
- The study aims to learn more about how acamprosate changes brain function in people with alcohol use disorder.
- Who it's for
- The study is looking for adults aged 21 to 65 who have moderate to severe alcohol use disorder.
- What's involved
- Participants will take a pill three times a day for 21 days and undergo brain scans called EEGs (which use sensors on the head to measure electrical activity) while performing simple tasks.
- Time commitment
- The study involves a 21-day stay in the clinic and up to three follow-up visits over six months.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug. 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 21 to 65
You may be able to join if
- Age 21-65. In younger participants, the central nervous system has not sufficiently developed, whereas in older participants, degenerative changes...
- Enrolled in NIAAA natural history protocol 14-AA-0181.
- Admitted to alcohol treatment program of NIAAA with moderate to severe alcohol use disorder by a clinician at the time of admission.
- Determination by the attending physician or licensed practitioner caring for the patient that the patient's current clinical status is stable enough...
You likely can't join if
- Use of naltrexone, disulfiram, benzodiazepines (except Oxazepam), antiepileptic compounds, antidepressants, neuroleptics, or acamprosate within a...
- Pregnancy at admission (negative urine pregnancy test required).
- History of head trauma associated with an unconscious state lasting more than 30 minutes, persistent sequelae, and/or cranial surgery.
- History of epilepsy.
- History of non-substance related psychotic disorders.
- Contraindications for acamprosate (previously exhibited hypersensitivity to acamprosate calcium or any of its compounds
See the full eligibility criteria
- Age 21-65. In younger participants, the central nervous system has not sufficiently developed, whereas in older participants, degenerative changes may confound the studied measures.
- Enrolled in NIAAA natural history protocol 14-AA-0181.
- Admitted to alcohol treatment program of NIAAA with moderate to severe alcohol use disorder by a clinician at the time of admission.
- Determination by the attending physician or licensed practitioner caring for the patient that the patient's current clinical status is stable enough to provide informed consent for research.
- Use of naltrexone, disulfiram, benzodiazepines (except Oxazepam), antiepileptic compounds, antidepressants, neuroleptics, or acamprosate within a time sufficient for the medication to be eliminated from the body (five...
- Pregnancy at admission (negative urine pregnancy test required).
- History of head trauma associated with an unconscious state lasting more than 30 minutes, persistent sequelae, and/or cranial surgery.
- History of epilepsy.
- History of non-substance related psychotic disorders.
- Contraindications for acamprosate (previously exhibited hypersensitivity to acamprosate calcium or any of its compounds
- Positive screens for alcohol or any illicit drugs (except THC) after admission and alcohol detoxification via breathanalysis and urine drug screen.
The study team makes the final eligibility decision.
Where it is enrolling
- Bethesda, Maryland, United States
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, but 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, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.