Naltrexone, Craving, and Drinking

NCT00006203 | Completed Phase 4 DMC

• 2 other identifiers: NIAAAMON0785011A1R01AA007850
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholism

Study Arms (2)

Naltrexone Arm

EXPERIMENTAL

Three weeks of daily 50mg Naltrexone

Drug: Naltrexone 50 Mg

Placebo Arm

PLACEBO COMPARATOR

Three weeks of daily placebo (sugar)

Drug: Placebo

Interventions

Naltrexone 50 Mg DRUG

Daily 50 mg for 3 weeks

Naltrexone Arm

Placebo DRUG

Daily doses of placebo for 3 weeks

Placebo Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brown University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Center for Alcohol and Addiction Studies, Brown University

Providence, Rhode Island, 02919, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

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

Study Record Dates

• First Submitted: September 11, 2000
• First Posted: September 12, 2000
• Study Completion: May 1, 2005
• Last Updated: June 13, 2025

Record last verified: 2006-10

Locations

US (1)