Naltrexone, Craving, and Drinking

Alcoholism Clinical Trial

Official title:

Naltrexone, Craving, and Drinking: Ecological Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006203
• Other study ID #: NIAAAMON0785011A1
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2000
• Last updated: October 20, 2006
• Est. completion date: May 2005

Study information

• Verified date: October 2006
• Source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• naltrexone (Revia)

Locations

Country	Name	City	State
United States	Center for Alcohol and Addiction Studies, Brown University	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,