Naltrexone, Craving, and Drinking

This study has been completed.

First Received on September 11, 2000. Last Updated on October 20, 2006 History of Changes

Sponsor:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00006203

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 IV

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:

MedlinePlus related topics: Alcoholism

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

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

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

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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
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 February 13, 2012