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Ghrelin for Alcohol Use in Non-Treatment-Seeking Heavy Drinkers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) )
ClinicalTrials.gov Identifier:
NCT01779024
First received: January 24, 2013
Last updated: June 14, 2017
Last verified: June 1, 2017
  Purpose

Background:

- Ghrelin is a hormone in the human body that is mostly produced by the stomach. It makes people feel hungry, and also is connected with the desire to drink alcohol. Researchers want to test ghrelin to see if it can be used to control alcohol cravings and use. They will compare doses of ghrelin with a placebo in people who drink heavily.

Objectives:

- To study the effects of ghrelin on alcohol craving and use.

Eligibility:

  • Individuals between 21 and 60 years of age who are heavy drinkers but are not seeking treatment for alcohol use.
  • Participants must on average have more than 20 drinks per week for men, and more than 15 drinks per week for women.

Design:

  • Participants will have a screening visit, four 2-night study visits, and a follow-up visit.
  • Participants will be screened with a physical exam and medical history. They will provide urine and breath samples for drug testing. They will also answer questions about mood and physical symptoms, and about alcohol and other cravings.
  • At the study visits, participants will stay overnight at the National Institutes of Health clinical center. They will spend the night at the center, have tests on the next day, and go home on the following morning. At each visit, participants will receive a ghrelin or placebo infusion, and will complete a series of tasks.
  • For the first and second study visits, participants will have tests of alcohol craving and use. They will be able to receive alcohol infusions through a computer program that tests response time and craving reactions. At the same time, they will have a ghrelin or a placebo infusion. Blood alcohol levels, reaction time, and craving will be studied.
  • For the third and fourth study visits, participants will have a magnetic resonance imaging (MRI) study. They will have an initial MRI to provide a picture of the brain. They will then have a functional MRI during which they will respond to a computer test. The test will allow them to win points for snack food or alcohol. This test will look at the brain s response time and craving reactions.
  • There will be a follow-up visit 1 week after the fourth study visit. Some of the tests from the screening visit will be repeated.

Condition Intervention Phase
fMRI Alcohol Drinking Alcoholism Drug: Ghrelin Drug: Placebo Procedure: fMRI Drug: Alcohol Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Other
Official Title: Effects of Ghrelin on Alcohol Administration in Non-Treatment Seeking Heavy Drinkers

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) ):

Primary Outcome Measures:
  • The primary measure of this study will be the breakpoint, which is the schedule (number of button presses) at which the individual stops to work for more alcohol during the PR sessions. [ Time Frame: Once per each condition (ghrelin vs. placebo) during the PR session ]

Secondary Outcome Measures:
  • fMRI BOLD signal in brain areas associated with incentive salience and areas associated with reward circuitry (including the ventral striatum) will be measured during the ?fMRI/ alcohol clamp? session. [ Time Frame: Once per each condition (ghrelin vs. placebo) during the fMRI/ alcohol clamp session ]
  • Urge to drink [ Time Frame: Repeated measures during each condition (ghrelin vs. placebo) during both the PR session and the fMRI/ alcohol clamp session ]
  • Alcohol sensitivity [ Time Frame: Repeated measures during each condition (ghrelin vs. placebo) during both the PR session and the fMRI/ alcohol clamp session ]
  • Adverse event [ Time Frame: Repeated measures during each condition (ghrelin vs. placebo) during both the PR session and the fMRI/ alcohol clamp session ]

Enrollment: 18
Study Start Date: December 13, 2012
Study Completion Date: June 1, 2017
Primary Completion Date: June 1, 2017 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Male and female participants between 21-60 years of age.

Good health as determined by medical history, physical exam, ECG and lab tests.

Creatinine less than to 2 mg/dl.

Female must have a negative urine pregnancy (hCG) test at the start of each study session. Females of childbearing potential who are sexually active and have not been surgically sterilized must agree to use an adequate method of birth control during the study. Adequate methods of contraception for sexually active women are having a male sexual partner(s) who is surgically sterilized prior to inclusion; having a sexual partner(s) who is/are exclusively female; using oral contraceptives (either combined or progestrogen only) with a single-barrier method of contraception consisting of spermicide and condom or diaphragm; using double-barrier contraception, specifically, a condom plus spermicide and a female diaphragm or cervical cap plus spermicide; or using an approved intrauterine device (IUD) with established efficacy.

Participants must drink alcohol regularly at a heavy level, on average greater than 20 drinks per week for men, and greater than 15 drinks per week for women, and not be seeking help for alcohol-related problems.

Participant must be willing to receive two IV lines.

EXCLUSION CRITERIA:

Current or prior history of any clinically significant disease, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.

Specific exclusion criteria related to the administration of ghrelin, are chronic inflammatory diseases (e.g., Crohn s disease, ulcerative colitis, celiac disease) diabetes, obesity (BMI greater than or equal 30 kg/m(2), weight greater than or equal to 120 Kg, high triglycerides level (> 350 mg/dL), history of clinically significant hypotension (e.g.: history of fainting and/or syncopal attacks) and/or resting systolic BP < 100 mmHg.

Positive hepatitis or HIV test at screening.

Current clinically significant major depression or anxiety; or prior clinically significant psychiatric problems, including eating disorders, schizophrenia, bipolar disorder, obsessive compulsive disorder.

Current diagnosis of substance dependence (other than alcohol or nicotine).

Currently seeking treatment for alcohol use disorder.

History of significant withdrawal symptoms or presence of clinically significant withdrawal symptoms (Clinical Institute Withdrawal Assessment (CIWA) score > 8) at screening.

Non-drinkers (alcohol-naive individuals or current abstainers) or no experience drinking 5 or more drinks on one occasion.

Unable to provide a negative urine drug screen.

Pregnancy or intention to become pregnant for women. Female participants will undergo a urine beta-hCG test to ensure they are not pregnant.

Use of prescription or OTC medications known to interact with alcohol within 2 weeks of the study. These include, but may not be limited to: isosorbide, nitroglycerine, benzodiazepines, warfarin, anti-depressants such as amitriptyline, clomipramine and nefazodone, anti-diabetes medications such as glyburide, metformin and tolbutamide, H2-antagonists for heartburn such as cimetidine and ranitidine, muscle relaxants, anti-epileptics including phenytoin and Phenobarbital codeine, and narcotics including darvocet, percocet and hydrocodone. Drugs known to inhibit or induce enzymes that metabolize alcohol should not be used for 4 weeks prior to the study. These include chlorzoxazone, isoniazid, metronidazole and disulfiram. Cough-and-cold preparations, which contain antihistamines, pain medicines and anti-inflammatories such as aspirin, ibuprofen, acetaminophen, celecoxib and naproxen, should be withheld for at least 72 hours prior to each study session.

Current or prior history of alcohol-induced flushing reactions.

Contraindications for MRI scanning, including metal in body that are contraindicated for MRI (such as implants, pacemaker, prostheses, shrapnel, irremovable piercings), left-handedness, and claustrophobia.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779024

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Lorenzo Leggio, M.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

Publications:

Responsible Party: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT01779024     History of Changes
Other Study ID Numbers: 130043
13-AA-0043
Study First Received: January 24, 2013
Last Updated: June 14, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) ):
Addiction
Alcohol
Alcohol Clamp

Additional relevant MeSH terms:
Alcoholism
Alcohol Drinking
Alcoholic Intoxication
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 26, 2017