Effects of EVT 302 With or Without NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of Cigarettes
NCT ID: NCT00622752
Last Updated: 2008-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2008-02-29
2008-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
EVT 302, 10 mg
EVT 302, 10 mg
2 X EVT 302, 5 mg tablets
2
EVT 302, 10 mg + NRT patch, 21 mg
EVT 302, 10 mg
2 X EVT 302, 5 mg tablets
Nicotine replacement therapy (NRT)
NRT patch containing 21 mg of nicotine
3
NRT patch, 21 mg
Nicotine replacement therapy (NRT)
NRT patch containing 21 mg of nicotine
4
Placebo to match EVT 302 and placebo patch to match NRT patch
placebo
2 X placebo tablets to match EVT 302 5 mg
NRT placebo
Medically inert plaster cut to match the NRT plaster
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EVT 302, 10 mg
2 X EVT 302, 5 mg tablets
placebo
2 X placebo tablets to match EVT 302 5 mg
Nicotine replacement therapy (NRT)
NRT patch containing 21 mg of nicotine
NRT placebo
Medically inert plaster cut to match the NRT plaster
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* 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
* 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
18 Years
55 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Evotec Neurosciences GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Evotec Neurosciences GmbH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alla Radicke, MD
Role: PRINCIPAL_INVESTIGATOR
Parexel International GmbH, Clinical Pharmacology Research Unit
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
PAREXEL International GmbH, Clinical Pharmacology Research Unit
Berlin, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EUDRACT No.: 2007-006236-63
Identifier Type: -
Identifier Source: secondary_id
EVT 302/3011
Identifier Type: -
Identifier Source: org_study_id