Naltrexone, Craving, and Drinking

This study has been completed.
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00006203
First received: September 11, 2000
Last updated: October 20, 2006
Last verified: October 2006
  Purpose

This 5-week study will examine the effects of naltrexone on alcohol craving, drinking rates, and reaction to drinking-related triggers, or cues, in participants' everyday environment and in laboratory sessions. Participants will monitor and record their daily desires to drink, environmental circumstances in which urges occur, and drinking behavior using a palm top computer. Participants will receive naltrexone or a placebo. One week after receiving medication, all participants will be asked to respond to alcohol-related cues that may or may not arouse the desire to drink.


Condition Intervention Phase
Alcoholism
Drug: naltrexone (Revia)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
Official Title: Naltrexone, Craving, and Drinking: Ecological Assessment

Resource links provided by NLM:


Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Estimated Enrollment: 186
Estimated Study Completion Date: May 2005
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Drink at least 4 days per week with 2 heavy drinking days (more than 6 standard drinks for men, more than 5 drinks for women) per week on average during the month prior to the study.

Exclusion Criteria:

  • Current interest in treatment or a history of treatment for alcohol problems.
  • History of liver disease or current liver function tests greater than five times normal.
  • Opiate abuse or dependence, any opiate use two weeks before the study or a urine test screen that is positive for opiates.
  • Females, who are pregnant, nursing, or not using reliable birth control method.
  • Daily use of acetaminophen.
  • Living with someone who participated in this study.
  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: NCT00006203

Locations
United States, Rhode Island
Center for Alcohol and Addiction Studies, Brown University
Providence, Rhode Island, United States, 02919
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006203     History of Changes
Other Study ID Numbers: NIAAAMON0785011A1
Study First Received: September 11, 2000
Last Updated: October 20, 2006
Health Authority: United States: Federal Government

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 September 18, 2014