Novel Medication as a Potential Smoking Cessation Aid
1 other identifier
interventional
56
1 country
1
Brief Summary
The purpose of this study is to provide preliminary information assessing if levomilnacipran may be effective at increasing smoking cessation rates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2014
CompletedFirst Posted
Study publicly available on registry
October 15, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
April 22, 2022
CompletedApril 22, 2022
March 1, 2022
2.3 years
October 9, 2014
March 28, 2022
March 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Levomilnacipran
EXPERIMENTALIn the first three week period levomilnacipran is evaluated whereas in the second three week period placebo is evaluated
Placebo
EXPERIMENTALIn the first three week period placebo is evaluated whereas in the second three week period levomilnacipran is evaluated
Interventions
Eligibility Criteria
You may qualify if:
- Be between 25 years old and 55 years old
- Smoke a minimum number of cigarettes per day
- Indicate motivation to quit smoking
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical and Translational Sciences Institute
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael Kotlyar
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Kotlyar, PharmD
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2014
First Posted
October 15, 2014
Study Start
January 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
April 22, 2022
Results First Posted
April 22, 2022
Record last verified: 2022-03