Trial Outcomes & Findings for Varenicline Treatment for Active Alcoholic Smokers (NCT NCT01347112)
NCT ID: NCT01347112
Last Updated: 2018-02-05
Results Overview
Prolonged smoking abstinence will be identified by a negative response to the question, "Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
33 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-02-05
Participant Flow
Participant milestones
| Measure |
Varenicline
varenicline 1.0 mg twice daily for 12 weeks
Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks
|
Sugar Pill
Varenicline look alike sugar pill twice daily for 12 weeks
placebo: sugar pill twice daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
|
Overall Study
COMPLETED
|
12
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
12
|
Reasons for withdrawal
| Measure |
Varenicline
varenicline 1.0 mg twice daily for 12 weeks
Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks
|
Sugar Pill
Varenicline look alike sugar pill twice daily for 12 weeks
placebo: sugar pill twice daily for 12 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
7
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
Baseline Characteristics
Varenicline Treatment for Active Alcoholic Smokers
Baseline characteristics by cohort
| Measure |
Varenicline
n=16 Participants
varenicline 1.0 mg twice daily for 12 weeks
Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks
|
Sugar Pill
n=17 Participants
Varenicline look alike sugar pill twice daily for 12 weeks
placebo: sugar pill twice daily for 12 weeks
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
38.8 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
39.5 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
tobacco use
|
19.1 cigarettes per day
STANDARD_DEVIATION 7.5 • n=5 Participants
|
21.6 cigarettes per day
STANDARD_DEVIATION 7.3 • n=7 Participants
|
20.4 cigarettes per day
STANDARD_DEVIATION 7.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksProlonged smoking abstinence will be identified by a negative response to the question, "Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"
Outcome measures
| Measure |
Varenicline
n=16 Participants
varenicline 1.0 mg twice daily for 12 weeks
Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks
|
Sugar Pil
n=17 Participants
Varenicline look alike sugar pill twice daily for 12 weeks
placebo: sugar pill twice daily for 12 weeks
|
|---|---|---|
|
Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment
|
6 participants
|
1 participants
|
SECONDARY outcome
Timeframe: week 24Prolonged abstinence is identified by a negative response to the question, "Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"
Outcome measures
| Measure |
Varenicline
n=16 Participants
varenicline 1.0 mg twice daily for 12 weeks
Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks
|
Sugar Pil
n=17 Participants
Varenicline look alike sugar pill twice daily for 12 weeks
placebo: sugar pill twice daily for 12 weeks
|
|---|---|---|
|
Prolonged Abstinence at 24 Weeks
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: week 12Heavy drinking is defined as 5 standard alcohol drinks or greater for men and 4 standard alcohol drinks or greater for women. The number of heavy drinking days per month was determined using the timeline follow-back method.
Outcome measures
| Measure |
Varenicline
n=16 Participants
varenicline 1.0 mg twice daily for 12 weeks
Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks
|
Sugar Pil
n=17 Participants
Varenicline look alike sugar pill twice daily for 12 weeks
placebo: sugar pill twice daily for 12 weeks
|
|---|---|---|
|
Heavy Drinking Days at End of Treatment
|
7.9 days
Standard Deviation 8.3
|
9.1 days
Standard Deviation 7.2
|
Adverse Events
Varenicline
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Varenicline
n=16 participants at risk
varenicline 1.0 mg twice daily for 12 weeks
Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks
|
Sugar Pill
n=17 participants at risk
Varenicline look alike sugar pill twice daily for 12 weeks
placebo: sugar pill twice daily for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
25.0%
4/16 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
|
General disorders
sleep disturbance
|
12.5%
2/16 • 12 weeks
|
0.00%
0/17 • 12 weeks
|
|
General disorders
vivid dreams
|
6.2%
1/16 • 12 weeks
|
5.9%
1/17 • 12 weeks
|
|
Psychiatric disorders
depressed mood
|
0.00%
0/16 • 12 weeks
|
5.9%
1/17 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place