Back to resultsNaltrexone, Craving, and Drinking
Primary Purpose
Alcoholism
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
naltrexone (Revia)
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism
Eligibility 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.
Sites / Locations
- Center for Alcohol and Addiction Studies, Brown University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006203
First Posted
September 11, 2000
Last Updated
October 20, 2006
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00006203
Brief Title
Naltrexone, Craving, and Drinking
Official Title
Naltrexone, Craving, and Drinking: Ecological Assessment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Allocation
Randomized
Enrollment
186 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
naltrexone (Revia)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Center for Alcohol and Addiction Studies, Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Naltrexone, Craving, and Drinking
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