Naltrexone, Craving, and Drinking

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2005-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

After a one-week placebo lead-in period, drinkers were randomized to 3 weeks of daily naltrexone or placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Naltrexone Arm

Three weeks of daily 50mg Naltrexone

Group Type EXPERIMENTAL

Naltrexone 50 Mg

Intervention Type DRUG

Daily 50 mg for 3 weeks

Placebo Arm

Three weeks of daily placebo (sugar)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Daily doses of placebo for 3 weeks

Interventions

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Naltrexone 50 Mg

Daily 50 mg for 3 weeks

Intervention Type DRUG

Placebo

Daily doses of placebo for 3 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No