This study is NOT currently recruiting participants.
Number
001644-AA
Sponsoring Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Recruitment Detail
Type: Recruitment has not started Gender: Male & Female Min Age: 21 Years Max Age: 65 Years
Referral Letter Required
No
Population Exclusion(s)
Pregnant Women;Children
Keywords
Multimodal; Neuroscience; Resting State; Event-Related Potentials; Artificial Intelligence; Machine Learning; ELECTROENCEPHALOGRAPHY; Acamprosate
Recruitment Keyword(s)
None
Condition(s)
Alcohol Use Disorder
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Drug: Acamprosate calcium Other: Placebo
Supporting Site
National Institute on Alcohol Abuse and Alcoholism
Chronic heavy drinking can cause alcohol use disorder (AUD). AUD changes how the brain works. People with AUD may drink compulsively or feel like they cannot control their alcohol use. Acamprosate is an FDA-approved drug that reduces anxiety and craving in some, but not all, people with AUD.
Objective:
To learn more about how acamprosate affects brain function in people with AUD.
Eligibility:
People aged 21 to 65 years with moderate to severe AUD.
Design:
Participants will stay in the clinic for 21 days after a detoxification period of approximately 7 days.
Acamprosate is a capsule taken by mouth. Half of participants will take this drug 3 times a day with meals. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which capsules they are taking.
Participants will have a procedure called electroencephalography (EEG): A gel will be applied to certain locations on their scalp, and a snug cap will be placed on their head. The cap has sensors with wires. The sensors detect electrical activity in the brain. Participants will lie still and perform 2 tasks: they will look at different shapes and press a button when they see a specific one; and they will listen to tones and press dedicated buttons when they hear the corresponding tones.
Participants will have 2 EEGs: 1 on day 2 and 1 on day 23 of their study participation. They may opt to have up to 4 more EEG studies (one on day 13 and one on each of the three follow-up visits) and 2 sleep studies, in which they would have sensors attached to their scalp while they sleep.
Participants may have up to three follow-up visits for 6 months.
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INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. 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. Moreover, the minimum legal drinking age is 21 years. 2. Enrolled in NIAAA natural history protocol 14-AA-0181. 3. Stated willingness to comply with all required study procedures and availability for the duration of the study. 4. Diagnosed with moderate to severe alcohol use disorder by a clinician at the time of admission. 5. Agreement to adhere to Lifestyle Considerations (see below) throughout study duration. During this study, participants are asked to: -Not wear any nicotine patches over the duration of the study visits. Nicotine users must refrain from use at least two hours before the study session commencement. -Not consume alcohol which is also a requirement for the NIH Clinical Center as they are inpatients seeking treatment for AUD. -If medications corresponding to exclusion from the study are indicated for the care of the participant, the participant will be immediately withdrawn from the study without impacting the financial compensation for participation prior to that indication. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Use of naltrexone, disulfiram, benzodiazepines (except Oxazepam), antiepileptic compounds, antidepressants, or neuroleptics currently or within the last 4 weeks. Individuals treated with acamprosate in the last 4 weeks would also be excluded. 2. Pregnancy at admission (negative urine pregnancy test required). 3. History of head trauma associated with an unconscious state lasting more than 30 minutes, persistent sequelae, and/or cranial surgery. 4. History of epilepsy. 5. History of non-substance related psychotic disorders. 6. Contraindications for acamprosate (previously exhibited hypersensitivity to acamprosate calcium or any of its compounds; and/or severe renal impairment, manifested as creatinine clearance <= 30 mL/min). 7. Positive screens for alcohol or any illicit drugs (except THC) at admission via breathanalysis and urine drug screen. 8. Current Clinical Institute Withdrawal Assessment (CIWA-Ar) score greater than or equal to 8. The participant can enroll in the study once their CIWA-Ar score drops below 8.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. 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. Moreover, the minimum legal drinking age is 21 years.
2. Enrolled in NIAAA natural history protocol 14-AA-0181.
3. Stated willingness to comply with all required study procedures and availability for the duration of the study.
4. Diagnosed with moderate to severe alcohol use disorder by a clinician at the time of admission.
5. Agreement to adhere to Lifestyle Considerations (see below) throughout study duration.
During this study, participants are asked to:
-Not wear any nicotine patches over the duration of the study visits. Nicotine users must refrain from use at least two hours before the study session commencement.
-Not consume alcohol which is also a requirement for the NIH Clinical Center as they are inpatients seeking treatment for AUD.
-If medications corresponding to exclusion from the study are indicated for the care of the participant, the participant will be immediately withdrawn from the study without impacting the financial compensation for participation prior to that indication.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Use of naltrexone, disulfiram, benzodiazepines (except Oxazepam), antiepileptic compounds, antidepressants, or neuroleptics currently or within the last 4 weeks.
Individuals treated with acamprosate in the last 4 weeks would also be excluded.
2. Pregnancy at admission (negative urine pregnancy test required).
3. History of head trauma associated with an unconscious state lasting more than 30 minutes, persistent sequelae, and/or cranial surgery.
4. History of epilepsy.
5. History of non-substance related psychotic disorders.
6. Contraindications for acamprosate (previously exhibited hypersensitivity to acamprosate calcium or any of its compounds; and/or severe renal impairment, manifested as creatinine clearance <= 30 mL/min).
7. Positive screens for alcohol or any illicit drugs (except THC) at admission via breathanalysis and urine drug screen.
8. Current Clinical Institute Withdrawal Assessment (CIWA-Ar) score greater than or equal to 8. The participant can enroll in the study once their CIWA-Ar score drops below 8.
Principal Investigator
Referral Contact
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