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Protocol Details

Ketogenic Diet (KD) in Alcoholism

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-AA-0152

Sponsoring Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 75

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Ketogenic Diet;
Detoxification;
Functional MRI;
MRI/MRS;
Alcoholism

Recruitment Keyword(s)

None

Condition(s)

Alcoholism

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Dietary Supplement: Ketogenic Diet (KD)
Dietary Supplement: Standard American (SA) Meals and Shakes

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

Background:

A ketogenic diet (KD) is high in fat and low in carbohydrates. Research has shown that a KD can lessen tremor in animals withdrawing from alcohol. KD can also help people who have difficulties with thinking, sleep, and mood. Researchers want to see if KD can lessen symptoms of alcohol withdrawal in people with alcohol use disorder.

Objective:<TAB>

To test the effects of a ketogenic diet on alcohol withdrawal symptoms.

Eligibility:

Adults 18 years or older who are moderate or severe alcohol drinkers and are seeking treatment for alcohol use. They must be in the NIAAA inpatient alcohol treatment program.

Design:

Participants will be screened under another protocol. They will have a medical and psychiatric history, physical exam, and blood and urine tests. Participants will have a breath test for alcohol.

The study will be done in a 3-week stay in the clinic.

Participants will get either a KD or Standard American diet.

Participants will have breathalyzer, blood, and urine tests.

Participants will have magnetic resonance imaging (MRI) scans. The scanner is a cylinder in a magnetic field. They will lie on a table that slides in and out of the cylinder. They will do tasks on a computer during the scan.

Participants will have tests of thinking, memory, and attention.

Participants will have their sleeping and waking measured. They will wear a device like a headband held in place with elastic straps. Several electrodes will be placed on the body.

Participants will have heart tests.

Participants will wear an activity monitor on the wrist.

After the clinic stay, participants will be called by phone about 5 times over 3 months.

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Eligibility

INCLUSION CRITERIA:

Patients with AUD

1. Age 18 years and older.

2. Ability to provide written informed consent as determined by clinical examination and verbal communication. Capacity to consent will be determined by those giving the informed consent.

3. DSM-IV diagnosis of alcohol dependence or alcohol abuse or DSM 5 diagnosis of moderate or severe AUD (established through history and clinical exam).

4. Participants seeking treatment for their AUD (self-report)

5. Minimum 5-year history of heavy drinking (SAMSHA s criteria for heavy drinking: for men 5 or more drinks/day on at least 5 different days per month; and for women 4 or more drinks/day on at least 5 different days per month.(self-report).

6. Alcohol specified as the preferred drug (self-report).

7. NIH employees with an AUD may participate in this study.

EXCLUSION CRITERIA:

1. Unwilling or unable to refrain from use, within 24 hours of MRI and NPT procedures, psychoactive medications or medication that may affect study results (e.g., analgesics containing narcotics, antibiotics [must finish course at least 24 hours prior to a scheduled procedure], antidiarrheal preparations, anti-inflammatory drugs [systemic corticosteroids are exclusionary], antinauseants, cough/cold preparations) (self-report, medical history). The following medications are allowable for entry on this study: analgesics (non-narcotic); antacids; antiasthma agents that are not systemic corticosteroids; antifungal agents for topical use; antihistamines (non-sedating); H2-Blockers/PPI (proton pump inhibitors); laxatives. The use of antihyperlipidemics and/or diuretics are permitted as long as they have been taken for at least 1 month before procedure visits and dose has been stabilized.

2. Current DSM-IV or DSM 5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders, or substance use disorders that are mild/moderate) that required hospitalization, or that required daily medications for over 4 weeks in the past year (i.e., antidepressants; anticholinergics; antipsychotics; anxiolytics; lithium; psychotropic drugs not otherwise specified (nos) including herbal products (no drugs with psychomotor effects or with anxiolytics, stimulant, antipsychotic, or sedative properties); sedatives/hypnotics). Chronic benzodiazepine use prior to alcohol detox will also be excluded. Note that nicotine and/or caffeine use will not exclude participation.

3. Chronic use of the following medications: analgesics containing narcotics; anorexics (sibuteramine); antianginal agents; antiarrhythmics; antiasthma agents that are systemic corticosteroids; antibiotics; anticoagulants; anticonvulsants; antidiarrheal preparations; antifungal agents (systemic); antihistamines (sedating); antihypertensives (except angiotensinconverting

enzymeace (ACE) inhibitors such as Lisinopril, or Angiotensin receptor blockers (ARB) such as Losartan); anti-inflammatory drugs (systemic); antineoplastics; antiobesity; antivirals (except for treatment of HSV with agents without CNS activity, e.g. acyclovir, ganciclovir, famciclovir, valacyclovir); cough/cold preparations (dextromethorphan preparations, pseudoephedrine); hormones (exceptions: thyroid hormone replacement, oral contraceptives, and estrogen replacement therapy); insulin; and muscle relaxants.

4. Major medical problems that can impact brain function or the use of a ketogenic diet (e.g., epilepsy, diabetes, liver disease, kidney disease, kidney stones (current and/or in the past), chronic metabolic acidosis or a cardiomyopathy) as determined by EKG, history and clinical exam.

5. Clinically significant laboratory findings that could affect brain function (e.g. HIV+).

6. Head trauma with loss of consciousness for more than 30 minutes (selfreport, medical history).

7. Pregnant or breast-feeding: Females of childbearing potential, or with tubal ligation, or are post-menopausal and are age 60 or less will undergo a urine pregnancy test and it must be negative to continue participation. Urine pregnancy tests will be repeated on subsequent days of study. Females must not be currently breastfeeding.

8. Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI (self-report checklist).

9. Cannot lie comfortably flat on his/her back for up to 2 hours in the MRI scanner (self-report).

10. Body weight > 550 lbs. The MR scanner bed is tested to a weight limit of 550 lbs.

11. Milk or soy allergy (self-report).

Note that subjects will not be excluded on initial screening from enrollment onto this study if their breath alcohol test is positive; or if their urine test is positive for drugs. The following guideline will be followed for positive alcohol/drug screens on study procedure days:

-If an AUD subject s breath alcohol and/or urine drug screen test is/are positive on study days (except for benzodiazepines during detox, including oxazepam, the procedures will be postponed and rescheduled to another day. If the urine drug screen is positive for THCCOOH, a saliva drug screen will be performed and subject may proceed with MRI/NPT procedures if saliva results for THC are negative. We will not place a limit on rescheduling study days.


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Citations:

Volkow ND, Kim SW, Wang GJ, Alexoff D, Logan J, Muench L, Shea C, Telang F, Fowler JS, Wong C, Benveniste H, Tomasi D. Acute alcohol intoxication decreases glucose metabolism but increases acetate uptake in the human brain. Neuroimage. 2013 Jan 1;64:277-83. doi: 10.1016/j.neuroimage.2012.08.057. Epub 2012 Aug 28.

Wang J, Du H, Jiang L, Ma X, de Graaf RA, Behar KL, Mason GF. Oxidation of ethanol in the rat brain and effects associated with chronic ethanol exposure. Proc Natl Acad Sci U S A. 2013 Aug 27;110(35):14444-9. doi: 10.1073/pnas.1306011110. Epub 2013 Aug 12.

Jiang L, Gulanski BI, De Feyter HM, Weinzimer SA, Pittman B, Guidone E, Koretski J, Harman S, Petrakis IL, Krystal JH, Mason GF. Increased brain uptake and oxidation of acetate in heavy drinkers. J Clin Invest. 2013 Apr;123(4):1605-14. doi: 10.1172/JCI65153. Epub 2013 Mar 8.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Corinde E. Wiers
National Institute on Alcohol Abuse and Alcoholism (NIAAA)



Megan S. Carraco
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
BG 10-CRC RM 1-3471
10 CENTER DR
BETHESDA MD 20814
(301) 496-5055
megan.carraco@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03255031

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