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Trial record 35 of 656 for:    "tobacco use disorder"

Novel Medication as a Potential Smoking Cessation Aid

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ClinicalTrials.gov Identifier: NCT02265367
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Drug: Levomilnacipran Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Novel Medication as a Potential Smoking Cessation Aid
Study Start Date : January 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Levomilnacipran
In this three week period, baseline measures are obtained during the first week, levomilnacipran will be started during the second week and effects on smoking behavior will be assessed during the third week
Drug: Levomilnacipran
Other Name: Fetzima
Placebo Comparator: Placebo
In this three week period, baseline measures are obtained during the first week, placebo will be started during the second week and effects on smoking behavior will be assessed during the third week
Drug: Placebo



Primary Outcome Measures :
  1. Number of days of confirmed abstinence (out of 5 maximum) [ Time Frame: 1 week ]
    Subjects will be asked to abstain for five consecutive days during the third week of each intervention period with the number of confirmed abstinence days being the primary outcome measure



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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265367


Locations
United States, Minnesota
Clinical and Translational Sciences Institute
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Michael Kotlyar, PharmD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02265367     History of Changes
Other Study ID Numbers: FRD14.42:
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Milnacipran
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents