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Naltrexone, Craving, and Drinking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00006203
Recruitment Status : Completed
First Posted : September 12, 2000
Last Update Posted : October 23, 2006
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: naltrexone (Revia) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Naltrexone, Craving, and Drinking: Ecological Assessment
Estimated Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006203


Locations
United States, Rhode Island
Center for Alcohol and Addiction Studies, Brown University
Providence, Rhode Island, United States, 02919
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
More Information

ClinicalTrials.gov Identifier: NCT00006203     History of Changes
Other Study ID Numbers: NIAAAMON0785011A1
First Posted: September 12, 2000    Key Record Dates
Last Update Posted: October 23, 2006
Last Verified: October 2006

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents