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NCT02265367 Clinical Trial

Novel Medication as a Potential Smoking Cessation Aid

Tobacco Use Disorder Clinical Trial

Official title:
Novel Medication as a Potential Smoking Cessation Aid

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02265367
Other study ID # 1409M53561
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date May 2017

Study information
Verified date March 2022
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 25 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Levomilnacipran

• Placebo

Locations
Country Name City State
United States Clinical and Translational Sciences Institute Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
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 5 days
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