Trial Outcomes & Findings for Varenicline for Alcohol Dependence (NCT NCT01146613)
NCT ID: NCT01146613
Last Updated: 2014-08-27
Results Overview
Protocol: The primary outcome measure examines the hypothesis that varenicline will decrease the weekly proportion of heavy drinking days during Study Weeks 2 through 13 as compared to placebo.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
Weeks 2-13*
Results posted on
2014-08-27
Participant Flow
Participant milestones
| Measure |
Varenicline
Varenicline Tartrate
Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks
|
Sugar Pill
Placebo: identical matched placebo x 2, 2xday, 13 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
101
|
|
Overall Study
COMPLETED
|
92
|
89
|
|
Overall Study
NOT COMPLETED
|
7
|
12
|
Reasons for withdrawal
| Measure |
Varenicline
Varenicline Tartrate
Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks
|
Sugar Pill
Placebo: identical matched placebo x 2, 2xday, 13 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
8
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
schedule conflict
|
1
|
0
|
|
Overall Study
Outpatient detox
|
1
|
0
|
Baseline Characteristics
Varenicline for Alcohol Dependence
Baseline characteristics by cohort
| Measure |
Varenicline
n=97 Participants
Varenicline Tartrate
Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks
|
Sugar Pill
n=101 Participants
Placebo: identical matched placebo x 2, 2xday, 13 weeks
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 11 • n=5 Participants
|
45 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
45.5 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=5 Participants
|
101 participants
n=7 Participants
|
198 participants
n=5 Participants
|
|
Drinks per day
|
14 drinks per day
STANDARD_DEVIATION 9.3 • n=5 Participants
|
12.5 drinks per day
STANDARD_DEVIATION 9 • n=7 Participants
|
13 drinks per day
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Drinks per drinking day
|
15.3 drinks per drinking day
STANDARD_DEVIATION 9.6 • n=5 Participants
|
13.6 drinks per drinking day
STANDARD_DEVIATION 9 • n=7 Participants
|
14.4 drinks per drinking day
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Percent days abstinent
|
7.7 percent days abstinent
STANDARD_DEVIATION 12.5 • n=5 Participants
|
7.9 percent days abstinent
STANDARD_DEVIATION 13.6 • n=7 Participants
|
7.8 percent days abstinent
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Percent heavy drinking days
|
88.1 percent heavy drinking days
STANDARD_DEVIATION 15.8 • n=5 Participants
|
87.2 percent heavy drinking days
STANDARD_DEVIATION 16.4 • n=7 Participants
|
87.7 percent heavy drinking days
STANDARD_DEVIATION 16.1 • n=5 Participants
|
|
Penn Alcohol Craving Scale Score
|
17.7 score
STANDARD_DEVIATION 6.2 • n=5 Participants
|
16.7 score
STANDARD_DEVIATION 6.8 • n=7 Participants
|
17.2 score
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Alcohol-related consequences score - ImBIBE
|
17.8 score
STANDARD_DEVIATION 9.8 • n=5 Participants
|
16.3 score
STANDARD_DEVIATION 9.7 • n=7 Participants
|
17 score
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Age of onset of regular drinking
|
18.7 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
19.3 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
19 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Gamma-glutamyl transpeptidase (GGT)
|
72.9 IU/L
STANDARD_DEVIATION 123.5 • n=5 Participants
|
70.1 IU/L
STANDARD_DEVIATION 103.1 • n=7 Participants
|
71.9 IU/L
STANDARD_DEVIATION 113.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 2-13*Protocol: The primary outcome measure examines the hypothesis that varenicline will decrease the weekly proportion of heavy drinking days during Study Weeks 2 through 13 as compared to placebo.
Outcome measures
| Measure |
Varenicline
n=97 Participants
Varenicline Tartrate
Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks
|
Sugar Pill
n=101 Participants
Placebo: identical matched placebo x 2, 2xday, 13 weeks
|
|---|---|---|
|
Weekly Percentage of Heavy Drinking Days
|
37.9 percentage of heavy drinking days
Standard Error 3.6
|
48.4 percentage of heavy drinking days
Standard Error 3.52
|
Adverse Events
Varenicline
Serious events: 2 serious events
Other events: 88 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 2 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline
n=97 participants at risk
Varenicline Tartrate
Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks
|
Sugar Pill
n=101 participants at risk
Placebo: identical matched placebo x 2, 2xday, 13 weeks
|
|---|---|---|
|
General disorders
Gout
|
0.00%
0/97
AEs were assessed by virtue of an open ended question and by subject report.
|
0.99%
1/101 • Number of events 1
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Injury, poisoning and procedural complications
Hospitalization for a Heniated Disc
|
0.00%
0/97
AEs were assessed by virtue of an open ended question and by subject report.
|
0.99%
1/101 • Number of events 1
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Injury, poisoning and procedural complications
Hospitalization for Back Surgery
|
1.0%
1/97 • Number of events 1
AEs were assessed by virtue of an open ended question and by subject report.
|
0.00%
0/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Injury, poisoning and procedural complications
Death From Gunshot Wound
|
1.0%
1/97 • Number of events 1
AEs were assessed by virtue of an open ended question and by subject report.
|
0.00%
0/101
AEs were assessed by virtue of an open ended question and by subject report.
|
Other adverse events
| Measure |
Varenicline
n=97 participants at risk
Varenicline Tartrate
Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks
|
Sugar Pill
n=101 participants at risk
Placebo: identical matched placebo x 2, 2xday, 13 weeks
|
|---|---|---|
|
Gastrointestinal disorders
constipation
|
9.3%
9/97
AEs were assessed by virtue of an open ended question and by subject report.
|
2.0%
2/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.3%
11/97
AEs were assessed by virtue of an open ended question and by subject report.
|
9.9%
10/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Gastrointestinal disorders
Nausea
|
37.1%
36/97
AEs were assessed by virtue of an open ended question and by subject report.
|
17.8%
18/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Gastrointestinal disorders
Vomiting
|
12.4%
12/97
AEs were assessed by virtue of an open ended question and by subject report.
|
9.9%
10/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
General disorders
Chest Pain
|
0.00%
0/97
AEs were assessed by virtue of an open ended question and by subject report.
|
5.9%
6/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
General disorders
Fatigue
|
14.4%
14/97
AEs were assessed by virtue of an open ended question and by subject report.
|
10.9%
11/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
General disorders
Irritability
|
11.3%
11/97
AEs were assessed by virtue of an open ended question and by subject report.
|
5.0%
5/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
6/97
AEs were assessed by virtue of an open ended question and by subject report.
|
6.9%
7/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.2%
5/97
AEs were assessed by virtue of an open ended question and by subject report.
|
4.0%
4/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.3%
9/97
AEs were assessed by virtue of an open ended question and by subject report.
|
6.9%
7/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.2%
6/97
AEs were assessed by virtue of an open ended question and by subject report.
|
8.9%
9/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Nervous system disorders
Dizziness
|
11.3%
11/97
AEs were assessed by virtue of an open ended question and by subject report.
|
5.9%
6/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Nervous system disorders
Dysgeusia
|
6.2%
6/97
AEs were assessed by virtue of an open ended question and by subject report.
|
0.99%
1/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Nervous system disorders
Headache
|
26.8%
26/97
AEs were assessed by virtue of an open ended question and by subject report.
|
29.7%
30/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Nervous system disorders
Somnolence
|
6.2%
6/97
AEs were assessed by virtue of an open ended question and by subject report.
|
12.9%
13/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Psychiatric disorders
Abnormal Dreams
|
27.8%
27/97
AEs were assessed by virtue of an open ended question and by subject report.
|
11.9%
12/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Psychiatric disorders
Agitation
|
12.4%
12/97
AEs were assessed by virtue of an open ended question and by subject report.
|
15.8%
16/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Psychiatric disorders
Anxiety
|
9.3%
9/97
AEs were assessed by virtue of an open ended question and by subject report.
|
7.9%
8/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Psychiatric disorders
Depression
|
7.2%
7/97
AEs were assessed by virtue of an open ended question and by subject report.
|
5.9%
6/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Psychiatric disorders
Hostility
|
6.2%
6/97
AEs were assessed by virtue of an open ended question and by subject report.
|
4.0%
4/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Psychiatric disorders
Insomnia
|
15.5%
15/97
AEs were assessed by virtue of an open ended question and by subject report.
|
11.9%
12/101
AEs were assessed by virtue of an open ended question and by subject report.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.1%
3/97
AEs were assessed by virtue of an open ended question and by subject report.
|
5.9%
6/101
AEs were assessed by virtue of an open ended question and by subject report.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The NIAAA Project Officer is responsible for overseeing the preparation of the main paper summarizing the main findings of the completed Study (the "Main Paper"). No single site data will be published or otherwise disseminated without first consulting and coordinating any such publication or dissemination with the investigators from all stakeholders. Additional manuscripts published after the publication of the Main Paper may be initiated and primarily authored by NIAAA.
- Publication restrictions are in place
Restriction type: OTHER