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Naltrexone for Heavy Drinking in Young Adults

This study has been completed.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00568958
First received: December 4, 2007
Last updated: July 22, 2014
Last verified: July 2014
History of Changes
Results First Received: March 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Alcohol Consumption
Alcoholic Intoxication
Alcoholism
Alcohol-induced Disorders
Interventions: Behavioral: BASICS counseling
Drug: naltrexone
Drug: placebo naltrexone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred primarily through Facebook advertisements and fliers. Following initial screening by phone or online surveys, individuals were invited for intake conducted by the research assistant at an outpatient university research clinic where written informed consent was obtained.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Naltrexone

Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling

BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.

naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks.
Placebo Naltrexone

Placebo Naltrexone (targeted + daily) + BASICS Counseling

BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.

placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks.

Participant Flow for 2 periods

 Period 1:   Allocation
    Naltrexone     Placebo Naltrexone  
STARTED     70     70  
COMPLETED     61     67  
NOT COMPLETED     9     3  
Withdrawal by Subject                 7                 3  
Physician Decision                 2                 0  

Period 2:   Follow-Up
    Naltrexone     Placebo Naltrexone  
STARTED     61     67  
COMPLETED     53     63  
NOT COMPLETED     8     4  
Withdrawal by Subject                 6                 3  
Physician Decision                 1                 1  
Family Emergency                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Naltrexone

Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling

BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.

naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks.
Placebo Naltrexone

Placebo Naltrexone (targeted + daily) + BASICS Counseling

BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.

placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks.
Total Total of all reporting groups

Baseline Measures
    Naltrexone     Placebo Naltrexone     Total  
Number of Participants  
[units: participants]
 		  61     67     128  
Age, Customized  
[units: participants]
 		     
18-25 year olds     61     67     128  
Gender  
[units: participants]
 		     
Female     18     22     40  
Male     43     45     88  
Race/Ethnicity, Customized  
[units: participants]
 		     
Caucasian     49     50     99  
Non-Caucasian     12     17     29  
Alcohol Use Diagnosis  
[units: participants]
 		     
No Diagnosis     16     11     27  
Alcohol Abuse     11     14     25  
Alcohol Dependence     34     42     76  



  Outcome Measures
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1.  Primary:   Frequency of Heavy Episodic Drinking   [ Time Frame: Baseline ]
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2.  Primary:   Frequency of Heavy Episodic Drinking   [ Time Frame: eight weeks ]
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3.  Primary:   Percent Days Abstinent From Drinking   [ Time Frame: Baseline ]
  Show Outcome Measure 3

4.  Primary:   Percent Days Abstinent From Drinking   [ Time Frame: 8 Weeks ]
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5.  Secondary:   Number of Drinks Per Drinking Day   [ Time Frame: Baseline ]
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6.  Secondary:   Number of Drinks Per Drinking Day   [ Time Frame: 8 Weeks ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Drinking to an Estimated Blood Alcohol Concentration (BAC) of .08 or Higher   [ Time Frame: 8 weeks ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Stephanie S. O'Malley
Organization: Yale University School of Medicine
phone: 203-974-7590
e-mail: stephanie.omalley@yale.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00568958     History of Changes
Other Study ID Numbers: NIAAA_OMALLEY-AA016621
R01AA016621 ( US NIH Grant/Contract Award Number )
NIH grant AA016621-01
Study First Received: December 4, 2007
Results First Received: March 4, 2014
Last Updated: July 22, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board