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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by National Institutes of Health Clinical Center (CC)
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: NA
Last verified: December 2012
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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):

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Urge to drink [ Time Frame: Repeated measures during each condition (ghrelin vs. placebo) during both the PR session and the fMRI/ alcohol clamp session ] [ Designated as safety issue: No ]
  • Alcohol sensitivity [ Time Frame: Repeated measures during each condition (ghrelin vs. placebo) during both the PR session and the fMRI/ alcohol clamp session ] [ Designated as safety issue: No ]
  • Adverse event [ Time Frame: Repeated measures during each condition (ghrelin vs. placebo) during both the PR session and the fMRI/ alcohol clamp session ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 124
Study Start Date: December 2012
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ghrelin
    N/A
    Drug: Placebo
    N/A
    Procedure: fMRI
    N/A
    Drug: Alcohol
    N/A
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
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 greater than or equal to 2 mg/dl.

Female must have a negative urine pregnancy (hCG) test at the start of each study session. Females of childbearing potential must agree to use a reliable method of birth control during the study. Reliable methods of birth control include oral contraceptives or Norplant(Registered Trademark); barrier methods such as diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices; a partner with a vasectomy; or abstinence from intercourse.

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 >= 30 kg/m2), high triglycerides level (> 350 mg/dL), history of clinically significant hypotension (e.g.: history of fainting and/or syncopal attacks).

Positive hepatitis or HIV test at screening.

Current history of Axis-I psychiatric illness.

Current or lifetime diagnosis of substance dependence.

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-na ve individuals or current abstainers) or no experience drinking 5 or more drinks on one occasion.

Positive result on 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

Contacts
Contact: Lorenzo Leggio, M.D. (301) 496-0000 Lorenzo.leggio@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Lorenzo Leggio, M.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( 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: January 24, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Addiction
Alcohol
Alcohol Clamp

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

ClinicalTrials.gov processed this record on July 31, 2014