Novel Medication as a Potential Smoking Cessation Aid

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

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Levomilnacipran

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Clinical and Translational Sciences Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Levomilnacipran; In the first three week period levomilnacipran is evaluated whereas in the second three week period placebo is evaluated	Drug: Placebo; Drug: Levomilnacipran; Other Names: Fetzima
Experimental: Placebo; In the first three week period placebo is evaluated whereas in the second three week period levomilnacipran is evaluated	Drug: Placebo; Drug: Levomilnacipran; Other Names: Fetzima

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Michael Kotlyar, PharmD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: October 9, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Milnacipran; Levomilnacipran
• Other Study ID Numbers: 1409M53561

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED