Smoking CessationPhase 2NCT00738595
Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation.
A Phase 2 study testing EVT 302 and EVT 302 plus open label Nicotine replacement in people with Smoking Cessation, run by Evotec Neurosciences GmbH at 9 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- EVT 302 and EVT 302 plus open label Nicotine replacement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 9 sitesGermany
- Study dates
- Aug 2008to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Evotec Study Site 2
Berlin
Evotec Study Site 3
Bochum
Evotec Study Site 8
Chemnitz
Evotec Study Site 4
Dresden
Evotec Study Site 5
Frankfurt
Evotec Study Site 7
Görlitz
Evotec Study Site 1
Leipzig
Evotec Study Site 6
Magdeburg
Evotec Study Site 9
Potsdam
About this study
Official title: Phase II Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation, Effect on it Own and in Combination With Open Label Nicotine Replacement Therapy.
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.
- Conditions
- Smoking Cessation
- Being tested
- EVT 302, Placebo, EVT 302 plus open label Nicotine replacement, Placebo plus open label Nicotine Replacement
- Keywords
- Smoking Cessation
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVT 302Drug
EVT 302 5 mg once daily
PlaceboDrug
Placebo to match EVT 302, 5 mg
EVT 302 plus open label Nicotine replacementDrug
Double-blind EVT 302 plus open label nicotine replacement
Placebo plus open label Nicotine ReplacementDrug
Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | EVT 302, 5 mg once Daily Receives: Drug: EVT 302 |
| 2 | Placebo comparator | Placebo once daily Receives: Drug: Placebo |
| 3 | Experimental | EVT 302 plus open label Nicotine replacement Receives: Drug: EVT 302 plus open label Nicotine replacement |
| 4 | Active comparator | Placebo plus nicotine replacement therapy Receives: Drug: Placebo plus open label Nicotine Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The four-week continuous quit rate over the last four weeks of treatment
Measured: Last 4 weeks of therapy
Secondary outcomes (10)
7 -week abstinence
Measured: 7 weeks post quit day
7-day point prevalence quit rate
Measured: weekly for 7 weeks
Daily cigarettes smoked
Measured: Daily
Change from baseline in the number of cigarettes smoked
Measured: Week 8
Minnesota Nicotine Withdrawal Scale
Measured: Weekly
Brief Questionnaire of Smoking Urges
Measured: Weekly
Modified Cigarette Evaluation Questionnaire
Measured: Weekly
Adverse Events
Measured: Weekly
Laboratory investigations (Haematology & biochemistry)
Measured: Weekly
ECGs
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evotec Neurosciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences, Clinpharm International Management Holding GmbH
- Investigators
- H D Stahl, MD, PhD, Principal investigator, ClinPharm International, Leipzig, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738595
- Sponsor's protocol ID
- EVT 302/3009
- Other IDs
- EUDRACT No.: 2008-002472-99
- Status last verified
- May 2009
- First submitted
- 18 Aug 2008
- Last updated
- 29 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37230961
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation, Effect on it Own and in Combination With Open Label Nicotine Replacement Therapy.
- ClinicalTrials.gov ID
- NCT00738595
- Acronym / sponsor ID
- EVT 302/3009
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Evotec Neurosciences GmbHIndustry (pharma, biotech, devices)
- Collaborators
- PRA Health Sciences, Clinpharm International Management Holding GmbH
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: EVT 302EVT 302, 5 mg once Daily |
| 2 | Placebo comparator | Drug: PlaceboPlacebo once daily |
| 3 | Experimental | Drug: EVT 302 plus open label Nicotine replacementEVT 302 plus open label Nicotine replacement |
| 4 | Active comparator | Drug: Placebo plus open label Nicotine ReplacementPlacebo plus nicotine replacement therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVT 302EVT 302 5 mg once daily | Drug | 1 |
| PlaceboPlacebo to match EVT 302, 5 mg | Drug | 2 |
| EVT 302 plus open label Nicotine replacementDouble-blind EVT 302 plus open label nicotine replacement | Drug | 3 |
| Placebo plus open label Nicotine ReplacementDouble-blind placebo plus open label Nicotine replacement patch 21 mg once daily. | Drug | 4 |
Primary outcome
The four-week continuous quit rate over the last four weeks of treatment
Time frame: Last 4 weeks of therapy
10 secondary outcomes
7 -week abstinence
Time frame: 7 weeks post quit day
7-day point prevalence quit rate
Time frame: weekly for 7 weeks
Daily cigarettes smoked
Time frame: Daily
Change from baseline in the number of cigarettes smoked
Time frame: Week 8
Minnesota Nicotine Withdrawal Scale
Time frame: Weekly
Brief Questionnaire of Smoking Urges
Time frame: Weekly
Modified Cigarette Evaluation Questionnaire
Time frame: Weekly
Adverse Events
Time frame: Weekly
Laboratory investigations (Haematology & biochemistry)
Time frame: Weekly
ECGs
Time frame: Weekly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2009.
- Derived from this study: PubMed 37230961Hajizadeh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H D Stahl, MD, PhD principal investigator
ClinPharm International, Leipzig, Germany
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EVT 302 and EVT 302 plus open label Nicotine replacement in people with Smoking Cessation, run by Evotec Neurosciences GmbH at 9 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The four-week continuous quit rate over the last four weeks of treatment (time frame: Last 4 weeks of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00738595, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2009.