The Effect of Naltrexone on Alcohol Craving and on Brain Activity During Alcohol Infusion

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00667771
First received: April 25, 2008
Last updated: April 5, 2011
Last verified: April 2011
  Purpose

This study will determine whether naltrexone, a medicine used to treat alcoholism, can lessen the craving for alcohol during alcohol withdrawal and examine how the drug affects brain activity during alcohol infusion.

People between 21 and 50 years of age who are right-handed, alcohol-dependent, and have at least one family member with a history of alcoholism, may be eligible for this study.

Participants are admitted to the NIH Clinical Center for 1 month for the following procedures:

Screening

  • Medical history, alcohol-use history and family history of alcoholism
  • Physical examination, psychological tests and blood tests
  • Medicine to lessen alcohol withdrawal symptoms, if necessary

Days 1-7

  • Alcohol detoxification
  • Medical and psychological evaluations
  • Assignment to naltrexone or placebo group

Days 7 through 28

  • Drug treatment: Take naltrexone or placebo capsule every morning
  • Additional alcohol-dependence treatment: Cognitive and behavioral therapies and participation in self-help groups, such as Alcoholics Anonymous
  • Weekly questionnaires to measure mood and desire for alcohol
  • Blood tests
  • Alcohol craving stimulation test (day 7): Subjects handle and sniff water and then their favorite alcoholic beverage. They then rate their urge to drink alcohol and their level of anxiety and their heart rate is measured.
  • Alcohol infusion test (day 9): Subjects have an MRI scan during infusion through a vein of saline (salt water), followed by infusion of alcohol. For this test, a catheter (plastic tube) is placed in a vein in each arm, one for administering the saline and then alcohol; the other for drawing blood samples to measure blood alcohol level and body chemistries. Before, during and after the infusion, subjects are asked to respond to questions about their feelings, cravings and mood changes.

Follow-up

Subjects are asked to participate in a 3-month outpatient assessment program involving five outpatient visits (at 1, 2, 4, 8 and 12 weeks after discharge). At each visit, they fill out questionnaires and to take a breathalyzer test and blood and urine tests for drugs. They may continue naltrexone therapy and weekly group therapy sessions during this time. Subjects who do not participate in the assessment program are contacted at home by phone once a week for 1 month and then every other week for the next 2 months to monitor alcohol abstinence.

...


Condition Intervention Phase
Alcohol Dependence
Alcoholism
Drug: Naltrexone
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Naltrexone on Craving and Ethanol-Induced Brain Activity

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • BOLD response during the ethanol infusion challenge

Secondary Outcome Measures:
  • Self-reported AUQ, PACS, OCDS, POMS and cue-induced craving during the CR session

Enrollment: 70
Study Start Date: April 2008
Study Completion Date: April 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Naltrexone
    N/A
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

All participants must:

  • be right-handed
  • between 21 and 50 years of age
  • meet the DSM-IV diagnostic criteria for alcohol dependence (polysubstance abuse is common in younger alcohol-dependent patients, and will not be exclusionary)
  • have a positive family history of alcoholism (one or more first-degree relatives with alcohol problems)

In addition, female participants:

  • must have a negative urine pregnancy test (beta-hCG)
  • of childbearing capability will be required to use a double contraceptive method (such as oral contraceptives, condom with spermicide or intra-uterine device with spermicide) from the start of the study until at least one month following the last dose of NTX.

EXCLUSION CRITERIA:

General exclusion criteria for the NIAAA Intramural treatment program:

  • people who present with complicated medical problems requiring intensive medical or diagnostic management, such as uncontrolled hypertension, gastro-intestinal (GI) bleeding, major organ or body system dysfunction or thyroid disease
  • people who are infected with human immunodeficiency virus (HIV)
  • serious neuro-psychiatric conditions which impair judgment or cognitive function to an extent that precludes them from providing informed consent or complying with study procedures, such as psychotic illness, or severe dementia (individuals not competent to give informed consent)
  • people who are unlikely or unable to complete the study because they are likely to be incarcerated while on the protocol
  • people who are required to receive treatment by a court of law or who are involuntarily committed to treatment

Specific exclusion criteria for this protocol include:

  • clinically significant hepatobiliary disease
  • a history of facial flushing in response to alcohol
  • a history of seizures
  • currently psychotic
  • currently abusing opioids
  • use of psychotropic medications (antidepressant, lithium, antipsychotic, anxiolytic, antiepileptic) regularly within the last 4 weeks prior to admission
  • having a positive pregnancy test, contemplating pregnancy in the next 3 months, nursing, or not using an effective contraceptive method (if the participant is of child-bearing potential)
  • a history of allergy or unusual reactions to NTX
  • have received treatment with NTX in the six-month period prior to enrollment
  • presence of ferromagnetic brain aneurysm clips, implanted pacemaker, hearing aid, or any other metallic implant, such as pins, screws, plates, dentures, or non-removable jewelry, in or on the body
  • pronounced 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: NCT00667771

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00667771     History of Changes
Other Study ID Numbers: 080125, 08-AA-0125
Study First Received: April 25, 2008
Last Updated: April 5, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Alcohol
Naltrexone
fMRI
Alcoholism
Alcoholics
Alcohol Dependence

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014