Trial Outcomes & Findings for Naltrexone for Heavy Drinking in Young Adults (NCT NCT00568958)

Last Updated: 2020-03-30

Results Overview

Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Frequency of heavy episodic drinking is measured as 5 or more drinks in a day for males, and 4 or more drinks in a day for females. A standard drink was equivalent to 0.6 gm of absolute alcohol (e.g., 12-oz beer, 5-oz wine, or 1.5-oz, 80-proof liquor). Baseline measures captured the prior 4 weeks.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

140 participants

Primary outcome timeframe

Baseline

Results posted on

2020-03-30

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Allocation STARTED	70	70
Allocation COMPLETED	61	67
Allocation NOT COMPLETED	9	3
Follow-Up STARTED	61	67
Follow-Up COMPLETED	52	60
Follow-Up NOT COMPLETED	9	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Allocation Withdrawal by Subject	7	3
Allocation Physician Decision	2	0
Follow-Up Withdrawal by Subject	6	6
Follow-Up Physician Decision	1	1
Follow-Up Family Emergency	1	0
Follow-Up Adverse Event	1	0

Baseline Characteristics

Naltrexone for Heavy Drinking in Young Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naltrexone n=61 Participants 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 n=67 Participants 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 n=128 Participants Total of all reporting groups
Age, Customized 18-25 year olds	61 participants n=5 Participants	67 participants n=7 Participants	128 participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	45 Participants n=7 Participants	88 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	49 participants n=5 Participants	50 participants n=7 Participants	99 participants n=5 Participants
Race/Ethnicity, Customized Non-Caucasian	12 participants n=5 Participants	17 participants n=7 Participants	29 participants n=5 Participants
Alcohol Use Diagnosis No Diagnosis	16 participants n=5 Participants	11 participants n=7 Participants	27 participants n=5 Participants
Alcohol Use Diagnosis Alcohol Abuse	11 participants n=5 Participants	14 participants n=7 Participants	25 participants n=5 Participants
Alcohol Use Diagnosis Alcohol Dependence	34 participants n=5 Participants	42 participants n=7 Participants	76 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Naltrexone n=61 Participants 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 n=67 Participants 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.
Frequency of Heavy Episodic Drinking	34.3 percentage of heavy drinking days Standard Deviation 16.76	33.4 percentage of heavy drinking days Standard Deviation 13.68

PRIMARY outcome

Timeframe: eight weeks

Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. Frequency of heavy episodic drinking is measured as 5 or more drinks in a day for males, and 4 or more drinks in a day for females over an eight week period. A standard drink was equivalent to 0.6 gm of absolute alcohol (e.g., 12-oz beer, 5-oz wine, or 1.5-oz, 80-proof liquor).

Outcome measures

Outcome measures
Measure	Naltrexone n=61 Participants 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 n=67 Participants 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.
Frequency of Heavy Episodic Drinking	21.6 percentage of heavy drinking days Standard Deviation 16.05	22.9 percentage of heavy drinking days Standard Deviation 13.20

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Naltrexone n=61 Participants 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 n=67 Participants 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.
Percent Days Abstinent From Drinking	43.3 % days abstinent Standard Deviation 21.77	49.5 % days abstinent Standard Deviation 14.69

PRIMARY outcome

Timeframe: 8 Weeks

Outcome measures

Outcome measures
Measure	Naltrexone n=61 Participants 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 n=67 Participants 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.
Percent Days Abstinent From Drinking	56.6 % days abstinent Standard Deviation 22.52	62.5 % days abstinent Standard Deviation 15.75

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Naltrexone n=61 Participants 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 n=67 Participants 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.
Number of Drinks Per Drinking Day	6.7 drinks per drinking day Standard Deviation 2.9	6.77 drinks per drinking day Standard Deviation 5.9

SECONDARY outcome

Timeframe: 8 Weeks

Outcome measures

Outcome measures
Measure	Naltrexone n=61 Participants 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 n=67 Participants 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.
Number of Drinks Per Drinking Day	4.9 drinks per drinking day Standard Deviation 2.28	5.9 drinks per drinking day Standard Deviation 2.51

SECONDARY outcome

Timeframe: 8 weeks

Self-reported drinking was primarily obtained through diary data, with the Timeline Follow-Back Interview (TLFB) used to replace missing data at baseline and at each biweekly visit over the 8-weeks.The eight weeks follow-up measure is summarized across all biweekly visits. BAL (Blood Alcohol Level) was estimated using data from the daily diaries based on the number of drinks consumed, the duration of drinking, and total body water (based on gender, age, height and weight) using Curtin's formula.

Outcome measures

Outcome measures
Measure	Naltrexone n=61 Participants 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 n=67 Participants 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.
Percentage of Drinking to an Estimated Blood Alcohol Concentration (BAC) of .08 or Higher	35.4 percentage of days Standard Deviation 28.40	45.7 percentage of days Standard Deviation 26.80

Adverse Events

Naltrexone

Serious events: 0 serious events

Other events: 52 other events

Deaths: 0 deaths

Placebo Naltrexone

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. Stephanie S. O'Malley

Yale University School of Medicine

Phone: 203-974-7590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Naltrexone n=61 participants at risk 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 n=67 participants at risk 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.
Skin and subcutaneous tissue disorders Rash	14.8% 9/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	9.0% 6/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
Skin and subcutaneous tissue disorders Itching	13.1% 8/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	7.5% 5/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
Skin and subcutaneous tissue disorders Sweating	6.6% 4/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	3.0% 2/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
Gastrointestinal disorders Nausea	36.1% 22/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	23.9% 16/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
Gastrointestinal disorders Vomiting	23.0% 14/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	16.4% 11/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
Gastrointestinal disorders diarrhea	6.6% 4/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	10.4% 7/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
Gastrointestinal disorders Abdominal Pain	6.6% 4/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	9.0% 6/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
General disorders Fatigue	18.0% 11/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	9.0% 6/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
General disorders Decreased Appetite	11.5% 7/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	13.4% 9/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
General disorders Increased Appetite	8.2% 5/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	10.4% 7/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
Nervous system disorders Headache	50.8% 31/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	34.3% 23/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
Nervous system disorders Insomnia	19.7% 12/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	20.9% 14/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
Nervous system disorders Dizziness	13.1% 8/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	10.4% 7/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
Nervous system disorders Sleepiness	16.4% 10/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	3.0% 2/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
Psychiatric disorders Anxiety	29.5% 18/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	20.9% 14/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
Psychiatric disorders Depression	6.6% 4/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	10.4% 7/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
Reproductive system and breast disorders Irregular Menses	22.2% 4/18 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	18.2% 4/22 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.
Reproductive system and breast disorders Change in Libido	3.3% 2/61 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.	9.0% 6/67 • Adverse event data were collected during the 8 week treatment period between March 2008 and January 2012.