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Novel Medication as a Potential Smoking Cessation Aid

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Levomilnacipran
Placebo
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tobacco Use Disorder

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical and Translational Sciences Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Levomilnacipran

Placebo

Arm Description

In the first three week period levomilnacipran is evaluated whereas in the second three week period placebo is evaluated

In the first three week period placebo is evaluated whereas in the second three week period levomilnacipran is evaluated

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 9, 2014
Last Updated
March 28, 2022
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02265367
Brief Title
Novel Medication as a Potential Smoking Cessation Aid
Official Title
Novel Medication as a Potential Smoking Cessation Aid
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levomilnacipran
Arm Type
Experimental
Arm Description
In the first three week period levomilnacipran is evaluated whereas in the second three week period placebo is evaluated
Arm Title
Placebo
Arm Type
Experimental
Arm Description
In the first three week period placebo is evaluated whereas in the second three week period levomilnacipran is evaluated
Intervention Type
Drug
Intervention Name(s)
Levomilnacipran
Other Intervention Name(s)
Fetzima
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percent of Days of Confirmed Abstinence (Out of 5 Maximum)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kotlyar, PharmD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical and Translational Sciences Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Novel Medication as a Potential Smoking Cessation Aid

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