Trial Outcomes & Findings for Sweet Preference and Alcohol Craving (NCT NCT01296646)

Results Overview

Percentage of heavy drinking days as derived from the Timeline Follow-back (TLFB) for the entire medication period. A heavy drinking day is defined as 5 or more standard drinks for a man and 4 or more standard drinks for a woman. A standard drink is 12-14 grams of ethanol or the amount contained in a 12 oz beer, 5 oz of wine or 1 1/2 oz of hard liquor.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

12 weeks

Results posted on

2013-11-25

Participant Flow

Recruitment occured primarily via community advertising by radio.

Subjects were screened and, if met criteria, randomized to placebo or naltrexone generally within 5-10 days.

Participant milestones

Participant milestones
Measure	Placebo Placebo taken once daily.	Naltrexone 50 mg of naltrexone orally daily.
Overall Study STARTED	40	40
Overall Study COMPLETED	29	29
Overall Study NOT COMPLETED	11	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sweet Preference and Alcohol Craving

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=40 Participants Placebo taken once daily.	Naltrexone n=40 Participants 50 mg of naltrexone orally daily.	Total n=80 Participants Total of all reporting groups
Age Continuous	48.3 years STANDARD_DEVIATION 8.4 • n=5 Participants	45.8 years STANDARD_DEVIATION 8.6 • n=7 Participants	47.0 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Percentage of heavy drinking days as derived from the Timeline Follow-back (TLFB) for the entire medication period. A heavy drinking day is defined as 5 or more standard drinks for a man and 4 or more standard drinks for a woman. A standard drink is 12-14 grams of ethanol or the amount contained in a 12 oz beer, 5 oz of wine or 1 1/2 oz of hard liquor.

Outcome measures

Outcome measures
Measure	Placebo n=40 Participants Placebo taken once daily.	Naltrexone n=40 Participants 50 mg of naltrexone orally daily.
Percent Heavy Drinking Days Sweet Liker - High Craving n=9	0.63 percentage of days Standard Deviation 0.18	0.14 percentage of days Standard Deviation 0.13
Percent Heavy Drinking Days Sweet Liker - Low Craving n=13	0.09 percentage of days Standard Deviation 0.12	0.17 percentage of days Standard Deviation 0.30
Percent Heavy Drinking Days Sweet Disliker - High Craving n=31	0.19 percentage of days Standard Deviation 0.23	0.16 percentage of days Standard Deviation 0.20
Percent Heavy Drinking Days Sweet Disliker - Low Craving n=27	0.12 percentage of days Standard Deviation 0.22	0.14 percentage of days Standard Deviation 0.27

SECONDARY outcome

Timeframe: 12 weeks

Percentage of abstinence days as derived from the Timeline Follow-Back (TLFB) for the entire medication period.

Outcome measures

Outcome measures
Measure	Placebo n=40 Participants Placebo taken once daily.	Naltrexone n=40 Participants 50 mg of naltrexone orally daily.
Percent Days Abstinent Sweet Disliker - High Craving n=31	0.64 percentage of days Standard Deviation 0.27	0.62 percentage of days Standard Deviation 0.34
Percent Days Abstinent Sweet Liker - High Craving n=9	0.27 percentage of days Standard Deviation 0.20	0.77 percentage of days Standard Deviation 0.29
Percent Days Abstinent Sweet Liker - Low Craving n=13	0.72 percentage of days Standard Deviation 0.16	0.67 percentage of days Standard Deviation 0.29
Percent Days Abstinent Sweet Disliker - Low Craving n=27	0.61 percentage of days Standard Deviation 0.34	0.66 percentage of days Standard Deviation 0.27

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Naltrexone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=40 participants at risk Placebo taken once daily.	Naltrexone n=40 participants at risk 50 mg of naltrexone orally daily.
Cardiac disorders Heart Attack	2.5% 1/40 • Number of events 1 • 12 weeks Subjects were asked at each visit if they had experienced any adverse events since prior visit.	0.00% 0/40 • 12 weeks Subjects were asked at each visit if they had experienced any adverse events since prior visit.

Other adverse events

Other adverse events
Measure	Placebo n=40 participants at risk Placebo taken once daily.	Naltrexone n=40 participants at risk 50 mg of naltrexone orally daily.
Gastrointestinal disorders Nausea	5.0% 2/40 • Number of events 2 • 12 weeks Subjects were asked at each visit if they had experienced any adverse events since prior visit.	7.5% 3/40 • Number of events 3 • 12 weeks Subjects were asked at each visit if they had experienced any adverse events since prior visit.

Additional Information

James C. Garbutt, M.D., Professor of Psychiatry

University of North Carolina at Chapel Hill

Phone: 919-966-4652

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place