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Naltrexone, Craving, and Drinking

Naltrexone, Craving, and Drinking: Ecological Assessment

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00006203
Enrollment
180
Registered
2000-09-12
Start date
Unknown
Completion date
2005-05-31
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism

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.

Interventions

Daily 50 mg for 3 weeks

DRUGPlacebo

Daily doses of placebo for 3 weeks

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Brown University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026