Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to provide preliminary information assessing if levomilnacipran may be effective at increasing smoking cessation rates.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levomilnacipran | Experimental | In the first three week period levomilnacipran is evaluated whereas in the second three week period placebo is evaluated |
|
| Placebo | Experimental | In the first three week period placebo is evaluated whereas in the second three week period levomilnacipran is evaluated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levomilnacipran | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
The investigators will evaluate if there are other reasons why someone may not be eligible to participate
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Kotlyar, PharmD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical and Translational Sciences Institute | Minneapolis | Minnesota | 55455 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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 | Posted | Mean | Standard Error | percentage of days non-smoking | 5 days |
|
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
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levomilnacipran | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sleep / Energy Changes | General disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Kotlyar | University of Minnesota | 612-625-1160 | kotly001@umn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 26, 2016 | Mar 25, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078862 | Levomilnacipran |
| ID | Term |
|---|---|
| D000078764 | Milnacipran |
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 |
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| 37 |
| 52 |
| EG001 | Placebo | 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 | 0 | 51 | 0 | 51 | 26 | 51 |
| Gastrointestinal Symptoms | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Changes in Mood, Anxiety or Irritability Level | Psychiatric disorders | Non-systematic Assessment |
|
| Dizziness | General disorders | Non-systematic Assessment |
|
| Excessive Sweating | General disorders | Non-systematic Assessment |
|
| Body aches / pains | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Dry mouth | General disorders | Non-systematic Assessment |
|
| Change in Appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cold / Seasonal Allergy Symptoms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |