Naltrexone Effects on Alcohol Intake

NCT00254670 | Completed

• 1 other identifier: H5612-26059
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine drinking behavior and decision-making while taking Naltrexone and placebo. This is a double-blind, randomized, placebo-controlled crossover study. There are two cycles: one cycle on Naltrexone and one cycle on placebo.

Conditions

Social Drinker

Keywords

Alcohol; Naltrexone

Interventions

Naltrexone DRUG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers who are 21-40 years of age
• If female, 7-20 alcoholic drinks must be consumed weekly.
• If male, 10-25 alcoholic drinks must be consumed weekly.
• If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device \[IUD\], hormonal birth control, or double barrier method \[male condom, female condom, or diaphragm plus a spermicidal agent such as contraceptive foam, jelly or cream\]).
• Must have a body mass index (BMI) ≥18 and ≤30.
• Able and willing to provide an informed consent.
• Able to understand and follow the instructions of the investigator, including the delayed discounting tasks.
• Have a breath alcohol concentration of less than 0.02 on visits 1, 2, 3, 5, and 6; and 0.00 on visits 4, 4a, 7 and 7a.

You may not qualify if:

• Positive urine drug screen
• Using Cocaine, stimulants (other than nicotine and caffeine), methamphetamine, and/or amphetamines greater than 30 times in the last 24 months
• Using inhalants, hallucinogens, ecstasy, and/or ketamine greater than 30 times in the last 24 months
• Current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use, including awaiting trial or supervision by a parole or probation officer
• Binge drinking more than three times per week (\>5 standard drinks in one session is a binge)
• Currently trying to quit alcohol use
• Current dependence on any other psychoactive drug (except nicotine or caffeine) and/or alcohol as determined by the study physician's assessment .
• Clinically significant medical or psychiatric illness as determined by screening blood tests, medical history, and physical exam performed by the study physician

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF

San Francisco, California, 94115, United States

Location

MeSH Terms

Interventions

Naltrexone

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 Officials

• Michael C Rowbotham, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2005
• First Posted: November 16, 2005
• Study Start: February 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2006
• Last Updated: May 8, 2023

Record last verified: 2011-03

Locations

US (1)