Novel Medication as a Potential Smoking Cessation Aid

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Levomilnacipran

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

Group Type EXPERIMENTAL

Levomilnacipran

Intervention Type DRUG

Placebo

Intervention Type DRUG

Placebo

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

Group Type EXPERIMENTAL

Levomilnacipran

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Levomilnacipran

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Fetzima

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No