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Naltrexone, Craving, and Drinking

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Brown University

Status and phase

Completed
Phase 4

Conditions

Alcoholism

Treatments

Drug: Naltrexone 50 Mg
Drug: Placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00006203
R01AA007850 (U.S. NIH Grant/Contract)
NIAAAMON0785011A1

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

180 participants in 2 patient groups, including a placebo group

Naltrexone Arm
Experimental group
Description:
Three weeks of daily 50mg Naltrexone
Treatment:
Drug: Naltrexone 50 Mg
Placebo Arm
Placebo Comparator group
Description:
Three weeks of daily placebo (sugar)
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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