Smoking CessationPhase 2NCT00622752
Effects of EVT 302 With or Without NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of Cigarettes
A Phase 2 study testing EVT 302, 10 mg and Nicotine replacement therapy (NRT) in people with Smoking Cessation, run by Evotec Neurosciences GmbH at 1 site in Germany.
Trial summary
This randomised, placebo-controlled study is designed to explore the effects of EVT 302 both with and without concomitant nicotine replacement therapy (NRT) on craving and withdrawal in smokers after short term deprivation of cigarettes. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- EVT 302, 10 mg and Nicotine replacement therapy (NRT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2008to May 2008
- 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 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male subjects between 18 and 55 years of age, inclusive
- BMI between 18 and 30, minimum weight of 50 kg
- Negative urine drug \& alcohol screen
- Able to comply with tyramine-restricted diet
- Smoking of ≥17 and ≤34 cigarettes per day for the past year and have not tried to quit smoking in the 3 months prior to screening
- Subjects are willing and able to quit for about 12 hours in each of three subsequent study periods
Show all 9Show fewer
- Previous experience of craving following smoking cessation
- Breath CO between 15 ppm and 20 ppm and cotinine in saliva and plasma at least 250 ng/mL at screening
- Liver function test results not above 1.5 times the upper normal limit (UNL) at screening visit and at re-assessment during the study.
Who cannot join
- Participation in another clinical study within 60 days of screening
- Evidence of active significant psychiatric or neurological disease or dependency other than cigarettes
- Are known to have or are a carrier of the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, has a positive result to the human immunodeficiency virus-1 and/or 2 (HIV-1 and/or HIV-2) antibodies
- Known hypersensitivity to MAO inhibitors or any substance that is contained in the study formulations
- Known allergy to plasters or NRT patches
- Previous participation in another study with EVT 302
Show all 15Show fewer
- Currently receiving treatment for smoking cessation
- Current use of tobacco products other than cigarettes
- Require treatment with any medication
- Subject with a clinically relevant abnormal 12-lead ECG recording or QTcB/F >430 ms
- Use of a prescription medicine within 14 days or 5 half-lives, whichever is the longer, of the start of dosing, or use of an over-the-counter medication during the 7 days before the study, including herbal remedies, but excluding paracetamol and vitamin supplements (provided intake does not exceed the daily recommended allowance)
- Subjects must not be planning to father a child or donate sperm, during the study and 3 months after the end of the study. Acceptable methods of contraception comprise barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least 2 month)
- Daily consumption of more than 5 cups of tea or coffee, or more than 1.0 litre of xanthine-containing drinks
- Recent myocardial infarction, unstable or worsening angina pectoris, prince metal angina, severe arrhythmias, recent stroke.
- Creatinine clearance (CLR) calculated according to the formula by Modification of Diet in Renal Disease (MDRD) of <80 mL/min
Trial locations and contacts
1 site in 1 country.
Germany1 site
PAREXEL International GmbH, Clinical Pharmacology Research Unit
Berlin, 14050
About this study
Official title: A Double-Blind, Randomized, Placebo- and NRT -Controlled Phase II Study to Assess the Effects of EVT 302 Alone and in Combination With NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of Cigarettes
This randomised, placebo-controlled study is designed to explore the effects of EVT 302 both with and without concomitant nicotine replacement therapy (NRT) on craving and withdrawal in smokers after short term deprivation of cigarettes.
- Conditions
- Smoking Cessation
- Being tested
- EVT 302, 10 mg, placebo, Nicotine replacement therapy (NRT), NRT placebo
- Keywords
- Smoking cessation, Craving, Smokers
- 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 302, 10 mgDrug
2 X EVT 302, 5 mg tablets
placeboDrug
2 X placebo tablets to match EVT 302 5 mg
Nicotine replacement therapy (NRT)Drug
NRT patch containing 21 mg of nicotine
NRT placeboDevice
Medically inert plaster cut to match the NRT plaster
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | EVT 302, 10 mg Receives: Drug: EVT 302, 10 mg |
| 2 | Experimental | EVT 302, 10 mg + NRT patch, 21 mg Receives: Drug: EVT 302, 10 mg; Drug: Nicotine replacement therapy (NRT) |
| 3 | Experimental | NRT patch, 21 mg Receives: Drug: Nicotine replacement therapy (NRT) |
| 4 | Placebo comparator | Placebo to match EVT 302 and placebo patch to match NRT patch Receives: Drug: placebo; Device: NRT placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Craving and withdrawal
Measured: Within 12 hours of the last cigarette
Secondary outcomes (5)
CogState Cognitive test Battery
Measured: 12 hours post last cigarette
Breath carbon monoxide levels
Measured: 12 hours post last cigarette
Salivary cotinine levels
Measured: 12 hours post last cigarette
Clinical safety lab tests
Measured: Up to 7 days post dose
Assessment of adverse events
Measured: Up to 7 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evotec Neurosciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alla Radicke, MD, Principal investigator, Parexel International GmbH, Clinical Pharmacology Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622752
- Sponsor's protocol ID
- EVT 302/3011
- Other IDs
- EUDRACT No.: 2007-006236-63
- Status last verified
- Jun 2008
- First submitted
- 13 Feb 2008
- Last updated
- 17 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo- and NRT -Controlled Phase II Study to Assess the Effects of EVT 302 Alone and in Combination With NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of Cigarettes
- ClinicalTrials.gov ID
- NCT00622752
- Acronym / sponsor ID
- EVT 302/3011
- Conditions
- Smoking Cessation
- Keywords
- Smoking cessation, Craving, Smokers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Evotec Neurosciences GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 25 Feb 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 randomised, placebo-controlled study is designed to explore the effects of EVT 302 both with and without concomitant nicotine replacement therapy (NRT) on craving and withdrawal in smokers after short term deprivation of cigarettes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: EVT 302, 10 mgEVT 302, 10 mg |
| 2 | Experimental | Drug: EVT 302, 10 mg, Drug: Nicotine replacement therapy (NRT)EVT 302, 10 mg + NRT patch, 21 mg |
| 3 | Experimental | Drug: Nicotine replacement therapy (NRT)NRT patch, 21 mg |
| 4 | Placebo comparator | Drug: placebo, Device: NRT placeboPlacebo to match EVT 302 and placebo patch to match NRT patch |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male subjects between 18 and 55 years of age, inclusive
- BMI between 18 and 30, minimum weight of 50 kg
- Negative urine drug \& alcohol screen
- Able to comply with tyramine-restricted diet
- Smoking of ≥17 and ≤34 cigarettes per day for the past year and have not tried to quit smoking in the 3 months prior to screening
Key exclusion criteria (15 listed)
- Participation in another clinical study within 60 days of screening
- Evidence of active significant psychiatric or neurological disease or dependency other than cigarettes
- Are known to have or are a carrier of the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, has a positive result to the human immunodeficiency virus-1 and/or 2 (HIV-1 and/or HIV-2) antibodies
- Known hypersensitivity to MAO inhibitors or any substance that is contained in the study formulations
- Known allergy to plasters or NRT patches
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 302, 10 mg2 X EVT 302, 5 mg tablets | Drug | 1, 2 |
| placebo2 X placebo tablets to match EVT 302 5 mg | Drug | 4 |
| Nicotine replacement therapy (NRT)NRT patch containing 21 mg of nicotine | Drug | 2, 3 |
| NRT placeboMedically inert plaster cut to match the NRT plaster | Device | 4 |
Primary outcome
Reduction in Craving and withdrawal
Time frame: Within 12 hours of the last cigarette
5 secondary outcomes
CogState Cognitive test Battery
Time frame: 12 hours post last cigarette
Breath carbon monoxide levels
Time frame: 12 hours post last cigarette
Salivary cotinine levels
Time frame: 12 hours post last cigarette
Clinical safety lab tests
Time frame: Up to 7 days post dose
Assessment of adverse events
Time frame: Up to 7 days post dose
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 17 Jun 2008.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
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.
Alla Radicke, MD principal investigator
Parexel International GmbH, Clinical Pharmacology Research Unit
1 site 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, 10 mg and Nicotine replacement therapy (NRT) in people with Smoking Cessation, run by Evotec Neurosciences GmbH at 1 site 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 9 inclusion and 15 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 17 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Reduction in Craving and withdrawal (time frame: Within 12 hours of the last cigarette). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2008.