Tobacco Use Disorder
Conditions
Brief summary
The purpose of this study is to provide preliminary information assessing if levomilnacipran may be effective at increasing smoking cessation rates.
Interventions
DRUGLevomilnacipran
DRUGPlacebo
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Be between 25 years old and 55 years old * Smoke a minimum number of cigarettes per day * Indicate motivation to quit smoking
Exclusion criteria
* Current or history of medical or psychiatric conditions that could interfere with measures being studied or that could be affected by the study medication * Use of medication that could interfere with measures to be studied or that could be expected to interact with levomilnacipran * Are pregnant or breast feeding The investigators will evaluate if there are other reasons why someone may not be eligible to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Days of Confirmed Abstinence (Out of 5 Maximum) | 5 days | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 28 |
| Total | 56 |
Baseline characteristics
| Characteristic | Levomilnacipran Then Placebo | Total | Placebo Then Levomilnacipran |
|---|---|---|---|
| Age, Continuous | 45 Years | 44 Years | 44 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 51 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 20 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 14 Participants | 30 Participants | 16 Participants |
| Region of Enrollment United States | 28 participants | 56 participants | 28 participants |
| Sex: Female, Male Female | 9 Participants | 16 Participants | 7 Participants |
| Sex: Female, Male Male | 19 Participants | 40 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 51 |
| other Total, other adverse events | 37 / 52 | 26 / 51 |
| serious Total, serious adverse events | 0 / 52 | 0 / 51 |
Outcome results
Primary
Percent of Days of Confirmed Abstinence (Out of 5 Maximum)
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
Time frame: 5 days
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Levomilnacipran | Percent of Days of Confirmed Abstinence (Out of 5 Maximum) | 46.9 percentage of days non-smoking | Standard Error 6.7 |
| Placebo | Percent of Days of Confirmed Abstinence (Out of 5 Maximum) | 42.0 percentage of days non-smoking | Standard Error 6.5 |