Trial Outcomes & Findings for Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit (NCT NCT01308736)
NCT ID: NCT01308736
Last Updated: 2017-07-17
Results Overview
50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
At 6-month follow-up
Results posted on
2017-07-17
Participant Flow
73 potential participants provided informed consent and were therefore "Enrolled," however 10 of these did not meet all eligibility criteria as they were completing the baseline measures. We therefore "Started" 63 randomized participants as indicated in the Participant Flow module.
Participant milestones
| Measure |
Varenicline
Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
|
Placebo Pill
Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
32
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Varenicline
Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
|
Placebo Pill
Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
|
|---|---|---|
|
Overall Study
Did not attend a single session
|
6
|
5
|
Baseline Characteristics
Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit
Baseline characteristics by cohort
| Measure |
Varenicline
n=31 Participants
Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
|
Placebo Pill
n=32 Participants
Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.03 years
STANDARD_DEVIATION 10.54 • n=5 Participants
|
44.81 years
STANDARD_DEVIATION 12.14 • n=7 Participants
|
44.43 years
STANDARD_DEVIATION 11.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
32 participants
n=7 Participants
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 6-month follow-up50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.
Outcome measures
| Measure |
Varenicline
n=31 Participants
Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
|
Placebo Pill
n=32 Participants
Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
|
|---|---|---|
|
Cigarette Reduction
|
10 participants
|
11 participants
|
Adverse Events
Varenicline
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo Pill
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Varenicline
n=31 participants at risk
Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
|
Placebo Pill
n=32 participants at risk
Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
|
|---|---|---|
|
Gastrointestinal disorders
Bloating
|
3.2%
1/31
|
0.00%
0/32
|
|
General disorders
Vivid or Bizarre Dreams
|
19.4%
6/31
|
12.5%
4/32
|
|
Gastrointestinal disorders
Nausea
|
29.0%
9/31
|
15.6%
5/32
|
|
Gastrointestinal disorders
Constipation
|
9.7%
3/31
|
9.4%
3/32
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
1/31
|
3.1%
1/32
|
|
Gastrointestinal disorders
Diarrhea
|
9.7%
3/31
|
12.5%
4/32
|
|
General disorders
Irritability
|
6.5%
2/31
|
6.2%
2/32
|
|
General disorders
Restlessness
|
3.2%
1/31
|
3.1%
1/32
|
|
Gastrointestinal disorders
Upset stomach
|
6.5%
2/31
|
0.00%
0/32
|
|
General disorders
Headache
|
3.2%
1/31
|
6.2%
2/32
|
|
General disorders
Dizzy/light-headed
|
9.7%
3/31
|
0.00%
0/32
|
|
General disorders
Insomnia or fitful sleep
|
3.2%
1/31
|
9.4%
3/32
|
|
General disorders
Sexual dysfunction
|
3.2%
1/31
|
3.1%
1/32
|
|
Gastrointestinal disorders
Abdominal cramps
|
3.2%
1/31
|
0.00%
0/32
|
|
General disorders
Toothache
|
3.2%
1/31
|
0.00%
0/32
|
|
General disorders
Congestion
|
6.5%
2/31
|
0.00%
0/32
|
|
Psychiatric disorders
Increased depressive symptoms
|
6.5%
2/31
|
6.2%
2/32
|
|
General disorders
Fatigue
|
6.5%
2/31
|
6.2%
2/32
|
|
General disorders
Cold/Flu symptoms
|
3.2%
1/31
|
9.4%
3/32
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
2/31
|
3.1%
1/32
|
|
General disorders
Increased appetite
|
3.2%
1/31
|
0.00%
0/32
|
|
Psychiatric disorders
Blunted affect
|
0.00%
0/31
|
3.1%
1/32
|
|
General disorders
Itchy
|
0.00%
0/31
|
3.1%
1/32
|
|
Endocrine disorders
Hot flashes
|
0.00%
0/31
|
3.1%
1/32
|
|
Cardiac disorders
Chest twitches
|
0.00%
0/31
|
3.1%
1/32
|
|
General disorders
Pulled muscle in back
|
0.00%
0/31
|
3.1%
1/32
|
|
Gastrointestinal disorders
Gas
|
0.00%
0/31
|
6.2%
2/32
|
|
Gastrointestinal disorders
Strained bowel movement
|
0.00%
0/31
|
3.1%
1/32
|
|
General disorders
Dry mouth
|
0.00%
0/31
|
3.1%
1/32
|
|
General disorders
Nose bleed
|
0.00%
0/31
|
3.1%
1/32
|
Additional Information
Dr. Marc Steinberg
Rutgers Robert Wood Johnson Medical School
Phone: 7322354341
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place