Trial Outcomes & Findings for Varenicline Treatment of Alcohol Dependence in Smokers (NCT NCT01553136)
NCT ID: NCT01553136
Last Updated: 2020-03-06
Results Overview
The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
weeks 9-12
Results posted on
2020-03-06
Participant Flow
Participant milestones
| Measure |
Varenicline
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
|
Sugar Pill
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
67
|
|
Overall Study
Completed Treatment
|
55
|
52
|
|
Overall Study
COMPLETED
|
48
|
45
|
|
Overall Study
NOT COMPLETED
|
16
|
22
|
Reasons for withdrawal
| Measure |
Varenicline
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
|
Sugar Pill
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
10
|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Scheduling Difficulties
|
5
|
4
|
Baseline Characteristics
Varenicline Treatment of Alcohol Dependence in Smokers
Baseline characteristics by cohort
| Measure |
Sugar Pill
n=67 Participants
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
|
Varenicline
n=64 Participants
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 11.7 • n=93 Participants
|
43.6 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
42.7 years
STANDARD_DEVIATION 11.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
116 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: weeks 9-12The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
Outcome measures
| Measure |
Varenicline
n=64 Participants
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
|
Placebo
n=67 Participants
Placebo: once per day for Days 1 to 3, twice per day for the remaining days
|
|---|---|---|
|
Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
|
2.07 log transformed percentage of days
Standard Error 0.23
|
2.25 log transformed percentage of days
Standard Error 0.20
|
PRIMARY outcome
Timeframe: weeks 13-16The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.
Outcome measures
| Measure |
Varenicline
n=64 Participants
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
|
Placebo
n=67 Participants
Placebo: once per day for Days 1 to 3, twice per day for the remaining days
|
|---|---|---|
|
Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
|
1.99 log transformed percentage of days
Standard Error 0.22
|
2.09 log transformed percentage of days
Standard Error 0.21
|
PRIMARY outcome
Timeframe: 8 weeksThe percentage of days of heavy drinking will be examined over the final 8 weeks of the study. A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol. Presented here is the average of the 8 weeks (reported as week 17 originally).
Outcome measures
| Measure |
Varenicline
n=64 Participants
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
|
Placebo
n=67 Participants
Placebo: once per day for Days 1 to 3, twice per day for the remaining days
|
|---|---|---|
|
Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment
|
2.40 percentage of heavy drinking days
Standard Error 0.21
|
2.28 percentage of heavy drinking days
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Weeks 13-16Smoking abstinence is defined by self-reported abstinence from smoking for the last four weeks of treatment (weeks 13-16) and a urine cotinine level less than 15ng/mL measured at week 17.
Outcome measures
| Measure |
Varenicline
n=64 Participants
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
|
Placebo
n=67 Participants
Placebo: once per day for Days 1 to 3, twice per day for the remaining days
|
|---|---|---|
|
Smoking Abstinence
|
8 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: End of treatment (Week 17)A self-report measure of negative consequences from drinking will be administered and the total score are analyzed. The ImBIBe, a measure of alcohol consequences based on the Drinker Inventory of Consequences (DRINC) was used. The DRINC total score has a range from 0-45, 45 being the highest score (or greatest number of negative consequences).
Outcome measures
| Measure |
Varenicline
n=64 Participants
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
|
Placebo
n=67 Participants
Placebo: once per day for Days 1 to 3, twice per day for the remaining days
|
|---|---|---|
|
Drinking Related Consequences
|
1.29 units on a scale
Standard Error 0.03
|
1.40 units on a scale
Standard Error 0.03
|
Adverse Events
Varenicline
Serious events: 2 serious events
Other events: 47 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline
n=64 participants at risk
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
|
Sugar Pill
n=67 participants at risk
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
1.6%
1/64 • Number of events 1
|
0.00%
0/67
|
|
Psychiatric disorders
Suicidal Behavior
|
1.6%
1/64 • Number of events 1
|
0.00%
0/67
|
Other adverse events
| Measure |
Varenicline
n=64 participants at risk
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
|
Sugar Pill
n=67 participants at risk
Varenicline: 0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
6.2%
4/64
|
6.0%
4/67
|
|
Psychiatric disorders
Anxiety
|
12.5%
8/64
|
9.0%
6/67
|
|
Psychiatric disorders
Depression
|
17.2%
11/64
|
11.9%
8/67
|
|
Nervous system disorders
Disturbance in Attention
|
9.4%
6/64
|
7.5%
5/67
|
|
Nervous system disorders
Fatigue
|
14.1%
9/64
|
19.4%
13/67
|
|
Nervous system disorders
Headache
|
25.0%
16/64
|
22.4%
15/67
|
|
Nervous system disorders
Insomnia
|
15.6%
10/64
|
13.4%
9/67
|
|
Nervous system disorders
Irritability
|
31.2%
20/64
|
29.9%
20/67
|
|
Nervous system disorders
Abnormal Dreams
|
43.8%
28/64
|
22.4%
15/67
|
|
Ear and labyrinth disorders
Rhinorrhea
|
17.2%
11/64
|
13.4%
9/67
|
|
Gastrointestinal disorders
Acid Reflux
|
7.8%
5/64
|
7.5%
5/67
|
|
Gastrointestinal disorders
Constipation
|
6.2%
4/64
|
13.4%
9/67
|
|
Gastrointestinal disorders
Decreased Appetite
|
17.2%
11/64
|
16.4%
11/67
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
4/64
|
14.9%
10/67
|
|
Gastrointestinal disorders
Dry Mouth
|
15.6%
10/64
|
7.5%
5/67
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
2/64
|
9.0%
6/67
|
|
Gastrointestinal disorders
Flatulence
|
15.6%
10/64
|
11.9%
8/67
|
|
Gastrointestinal disorders
Taste Perversion
|
4.7%
3/64
|
7.5%
5/67
|
|
Gastrointestinal disorders
Increased Appetite
|
17.2%
11/64
|
14.9%
10/67
|
|
Gastrointestinal disorders
Increased Bowel Movements
|
6.2%
4/64
|
3.0%
2/67
|
|
Gastrointestinal disorders
Nausea
|
39.1%
25/64
|
26.9%
18/67
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
4/64
|
10.4%
7/67
|
|
Renal and urinary disorders
Frequent Urination
|
18.8%
12/64
|
10.4%
7/67
|
|
Musculoskeletal and connective tissue disorders
Joint Pain and Swelling
|
4.7%
3/64
|
7.5%
5/67
|
|
Eye disorders
Blurred Vision
|
6.2%
4/64
|
3.0%
2/67
|
|
General disorders
Diaphoresis
|
4.7%
3/64
|
6.0%
4/67
|
Additional Information
Stephanie Samples O'Malley, PhD, Professor of Psychiatry
Yale University
Phone: (203) 974-7590
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place