NCT00738595

Brief Summary

This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated to quit smoking. EVT 302 will be compared to placebo both with and without open label nicotine replacement therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 29, 2009

Status Verified

May 1, 2009

Enrollment Period

7 months

First QC Date

August 18, 2008

Last Update Submit

May 28, 2009

Conditions

Smoking Cessation

Keywords

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • The four-week continuous quit rate over the last four weeks of treatment

    Last 4 weeks of therapy

Secondary Outcomes (10)

  • 7 -week abstinence

    7 weeks post quit day

  • 7-day point prevalence quit rate

    weekly for 7 weeks

  • Daily cigarettes smoked

    Daily

  • Change from baseline in the number of cigarettes smoked

    Week 8

  • Minnesota Nicotine Withdrawal Scale

    Weekly

  • +5 more secondary outcomes

Study Arms (4)

1

EXPERIMENTAL

EVT 302, 5 mg once Daily

Drug: EVT 302

2

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

3

EXPERIMENTAL

EVT 302 plus open label Nicotine replacement

Drug: EVT 302 plus open label Nicotine replacement

4

ACTIVE COMPARATOR

Placebo plus nicotine replacement therapy

Drug: Placebo plus open label Nicotine Replacement

Interventions

EVT 302DRUG

EVT 302 5 mg once daily

1
PlaceboDRUG

Placebo to match EVT 302, 5 mg

2
EVT 302 plus open label Nicotine replacementDRUG

Double-blind EVT 302 plus open label nicotine replacement

3
Placebo plus open label Nicotine ReplacementDRUG

Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.

4

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoker of at least 10 cigarettes daily
  • Motivated to quit smoking
  • Reports at least one unsuccessful attempt to quit in the last 2 years
  • In generally good health
  • Provides written informed consent to participate in the sudy

You may not qualify if:

  • Pregnant or nursing females.
  • Women of child-bearing potential must agree to use acceptable contraceptive precautions (contraceptive pill and one barrier method)during the study and for 2-months thereafter
  • History of anaphylaxis
  • History of alcohol or drug abuse
  • History of or current significant medical or psychiatric disorder
  • History or presence of cataract or abnormality identified by slit lamp investigation
  • Use of other MAO inhibitors, pethidine, SSRIs, tricyclic antidepressants,nasal or oral decongestants or cold medicines containing ephedrine, pseudoephedrine or other sympathomimetics.
  • Any medicine contraindicated for use with MAO inhibitors.
  • Have or be a carrier of hepatitis B or c or HIV 1 or 2
  • Use of tobacco products other than cigarettes
  • Use of nicotine replacement therapy in the past month
  • Received an investigational drug in the past 30 days
  • Previous participation in a study with a MAO-B inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Evotec Study Site 2

Berlin, Germany

Location

Evotec Study Site 3

Bochum, Germany

Location

Evotec Study Site 8

Chemnitz, Germany

Location

Evotec Study Site 4

Dresden, Germany

Location

Evotec Study Site 5

Frankfurt, Germany

Location

Evotec Study Site 7

Görlitz, Germany

Location

Evotec Study Site 1

Leipzig, Germany

Location

Evotec Study Site 6

Magdeburg, Germany

Location

Evotec Study Site 9

Potsdam, Germany

Location

Related Publications (1)

  • Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

    PMID: 37230961DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

sembragiline

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • H D Stahl, MD, PhD

    ClinPharm International, Leipzig, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 20, 2008

Study Start

August 1, 2008

Primary Completion

March 1, 2009

Study Completion

May 1, 2009

Last Updated

May 29, 2009

Record last verified: 2009-05

Locations

DE(9)