Naltrexone for Heavy Drinking in Young Adults

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, 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
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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.
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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
Overall Participants Analyzed; [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 ]

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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 ]

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7. Secondary:

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

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  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):

O'Malley SS, Corbin WR, Leeman RF, DeMartini KS, Fucito LM, Ikomi J, Romano DM, Wu R, Toll BA, Sher KJ, Gueorguieva R, Kranzler HR. Reduction of alcohol drinking in young adults by naltrexone: a double-blind, placebo-controlled, randomized clinical trial of efficacy and safety. J Clin Psychiatry. 2015 Feb;76(2):e207-13. doi: 10.4088/JCP.13m08934.

Responsible Party:	Yale University
ClinicalTrials.gov Identifier:	NCT00568958 History of Changes
Other Study ID Numbers:	NIAAA_OMALLEY-AA016621; R01AA016621 ( U.S. NIH Grant/Contract ); NIH grant AA016621-01
First Submitted:	December 4, 2007
First Posted:	December 6, 2007
Results First Submitted:	March 4, 2014
Results First Posted:	August 11, 2014
Last Update Posted:	August 11, 2014