Naltrexone for Early Problem Drinkers - Tabular View

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Naltrexone for Early Problem Drinkers

This study has been completed.

Study NCT00000455. Last updated on June 23, 2005. Information provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Naltrexone for Early Problem Drinkers
Official Title ^†	Targeted Naltrexone for Early Problem Drinkers
Brief Summary	Early problem drinkers are prevalent in the United States. Recent controlled trials have shown that brief interventions in the primary care setting can reduce drinking and alcohol-related problems in patients who lack evidence of alcohol dependence. Although naltrexone (Revia) has been approved for the treatment of alcohol dependence, few pharmacotherapy studies have been undertaken with early problem drinkers. This study is an 8-week trial of naltrexone versus placebo, combined with coping skills treatment that either focuses on targeted use of medication or serves as background to daily use of the medication. A total of 160 early problem drinkers recruited through screening in primary care medical settings will be randomly assigned to one of four treatment groups. Followup evaluations will be conducted at the end of treatment and again 3, 6, and 12 months.
Detailed Description
Study Phase	Phase IV
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Placebo Control, Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Alcoholism
Intervention ^†	Drug: naltrexone
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	160
Start Date ^†
Completion Date	September 2002
Eligibility Criteria ^†	Inclusion Criteria: Limited to early problem drinkers (i.e., those with no more than mild alcohol dependence). Have an average weekly alcohol consumption of greater than or equal to 24 standard drinks for men and 18 standard drinks for women. Able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment. Willing to provide a collateral informant for interviews regarding the patient's drinking during the study. A woman of child-bearing potential must be non-lactating, practicing a reliable method of birth control, and have a negative pregnancy test prior to initiation of treatment. Willing to provide a signed informed consent to participate in the study. Exclusion Criteria: Have a current clinically significant physical disease or abnormality. Have a serious psychiatric illness. Have a current diagnosis of drug dependence (other than nicotine dependence) or a lifetime diagnosis of opioid dependence. A current diagnosis of alcohol dependence that is moderate or greater in severity or a history of alcohol withdrawal, or recurrent use of alcohol to alleviate alcohol withdrawal symptoms. Used opioids or other psychoactive medications regularly in the month prior to study enrollment. History of hypersensitivity to naltrexone (Revia).
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00000455
Organization ID	NIAAAKRA11062
Secondary IDs ^††
Study Sponsor ^†	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators ^††
Investigators ^†
Information Provided By	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date	November 2004
First Received Date ^†	November 2, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.