Trial Outcomes & Findings for Novel Medication as a Potential Smoking Cessation Aid (NCT NCT02265367)
NCT ID: NCT02265367
Last Updated: 2022-04-22
Results Overview
Subjects will be asked to abstain for five consecutive days during the third week of each intervention period with the percentage of confirmed abstinence days being the primary outcome measure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
5 days
Results posted on
2022-04-22
Participant Flow
Participant milestones
| Measure |
Levomilnacipran Then Placebo
In the first three week period, baseline measures are obtained during the first week, levomilnacipran started during the second week and effects on smoking behavior assessed during the third week. For the subsequent three-week period, washout occurs during the first week, placebo is started during the second week and effects on smoking behavior assessed during the third week.
|
Placebo Then Levomilnacipran
In the first three week period, baseline measures are obtained during the first week, placebo started during the second week and effects on smoking behavior assessed during the third week. For the subsequent three-week period, washout occurs during the first week, levomilnacipran is started during the second week and effects on smoking behavior assessed during the third week.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
Completed First 3-week Period
|
24
|
26
|
|
Overall Study
COMPLETED
|
18
|
22
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Novel Medication as a Potential Smoking Cessation Aid
Baseline characteristics by cohort
| Measure |
Levomilnacipran Then Placebo
n=28 Participants
In the first three week period, baseline measures are obtained during the first week, levomilnacipran started during the second week and effects on smoking behavior assessed during the third week. For the subsequent three-week period, washout occurs during the first week, placebo is started during the second week and effects on smoking behavior assessed during the third week.
|
Placebo Then Levomilnacipran
n=28 Participants
In the first three week period, baseline measures are obtained during the first week, placebo started during the second week and effects on smoking behavior assessed during the third week. For the subsequent three-week period, washout occurs during the first week, levomilnacipran is started during the second week and effects on smoking behavior assessed during the third week.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 Years
n=93 Participants
|
44 Years
n=4 Participants
|
44 Years
n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
51 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
|
2 Participants
n=4 Participants
|
2 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
|
12 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=93 Participants
|
28 participants
n=4 Participants
|
56 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 5 daysPopulation: Only participants who completed the study were analyzed. Completers were those with data from at least 2 days during the third week of the second three week period
Subjects will be asked to abstain for five consecutive days during the third week of each intervention period with the percentage of confirmed abstinence days being the primary outcome measure
Outcome measures
| Measure |
Levomilnacipran
n=40 Participants
In this three week period, baseline measures are obtained during the first week, levomilnacipran started during the second week and effects on smoking behavior assessed during the third week.
|
Placebo
n=40 Participants
In this three week period, baseline measures are obtained during the first week, placebo during the second week and effects on smoking behavior during the third week
|
|---|---|---|
|
Percent of Days of Confirmed Abstinence (Out of 5 Maximum)
|
46.9 percentage of days non-smoking
Standard Error 6.7
|
42.0 percentage of days non-smoking
Standard Error 6.5
|
Adverse Events
Levomilnacipran
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Levomilnacipran
n=52 participants at risk
In this three week period, baseline measures are obtained during the first week, levomilnacipran will be started during the second week and effects on smoking behavior will be assessed during the third week
Levomilnacipran
|
Placebo
n=51 participants at risk
In this three week period, baseline measures are obtained during the first week, placebo will be started during the second week and effects on smoking behavior will be assessed during the third week
Placebo
|
|---|---|---|
|
General disorders
Sleep / Energy Changes
|
30.8%
16/52 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
23.5%
12/51 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
|
Gastrointestinal disorders
Gastrointestinal Symptoms
|
21.2%
11/52 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
19.6%
10/51 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
|
General disorders
Headache
|
17.3%
9/52 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
15.7%
8/51 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
|
Psychiatric disorders
Changes in Mood, Anxiety or Irritability Level
|
13.5%
7/52 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
3.9%
2/51 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
|
General disorders
Dizziness
|
1.9%
1/52 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
9.8%
5/51 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
|
General disorders
Excessive Sweating
|
5.8%
3/52 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
5.9%
3/51 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
|
Musculoskeletal and connective tissue disorders
Body aches / pains
|
7.7%
4/52 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
3.9%
2/51 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
|
General disorders
Dry mouth
|
5.8%
3/52 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
3.9%
2/51 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
|
Gastrointestinal disorders
Change in Appetite
|
5.8%
3/52 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
3.9%
2/51 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cold / Seasonal Allergy Symptoms
|
11.5%
6/52 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
5.9%
3/51 • Adverse events that were reported during the period (up to 2 weeks) when participants were taking either levomilnacipran or placebo
Participants were asked to report any side effects or health changes that occurred regardless of whether they thought that these were related to the study medication
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place