Novel Medication as a Potential Smoking Cessation Aid

Not Applicable

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Drug: Levomilnacipran; Drug: Placebo

• Registration Number: NCT02265367
• Lead Sponsor: University of Minnesota

Brief Summary

The purpose of this study is to provide preliminary information assessing if levomilnacipran may be effective at increasing smoking cessation rates.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-15
• Study Start: 2015-01
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2022-03
• Results First Submitted: 2022-03-28
• Results First Submitted QC: 2022-03-28
• Last Update Submitted: 2022-03-28
• Results First Posted: 2022-04-22
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Levomilnacipran	In the first three week period placebo is evaluated whereas in the second three week period levomilnacipran is evaluated
Levomilnacipran	Placebo	In the first three week period levomilnacipran is evaluated whereas in the second three week period placebo is evaluated
Placebo	Placebo	In the first three week period placebo is evaluated whereas in the second three week period levomilnacipran is evaluated
Levomilnacipran	Levomilnacipran	In the first three week period levomilnacipran is evaluated whereas in the second three week period placebo is evaluated

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Clinical and Translational Sciences Institute; 🇺🇸 Minneapolis, Minnesota, United States