Naltrexone, Craving, and Drinking

June 11, 2025 updated by: Peter Monti, Brown University

Naltrexone, Craving, and Drinking: Ecological Assessment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02919
        • Center for Alcohol and Addiction Studies, Brown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Naltrexone Arm
Three weeks of daily 50mg Naltrexone
Drug: Naltrexone 50 Mg
Daily 50 mg for 3 weeks
Placebo Comparator: Placebo Arm
Three weeks of daily placebo (sugar)
Drug: Placebo
Daily doses of placebo for 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion

May 1, 2005

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

September 11, 2000

First Posted (Estimated)

September 12, 2000

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 11, 2025

Last Verified

October 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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