Effects of EVT 302 With or Without NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of Cigarettes

Smoking Cessation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00622752
• Other study ID #: EVT 302/3011
• Secondary ID: EUDRACT No.: 200
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2008
• Last updated: June 16, 2008
• Start date: February 2008
• Est. completion date: May 2008

Study information

• Verified date: June 2008
• Source: Evotec Neurosciences GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

• 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:

• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• 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

Device:
• NRT placebo
Medically inert plaster cut to match the NRT plaster

Locations

Country	Name	City	State
Germany	PAREXEL International GmbH, Clinical Pharmacology Research Unit	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Evotec Neurosciences GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Craving and withdrawal		Within 12 hours of the last cigarette	No
Secondary	CogState Cognitive test Battery		12 hours post last cigarette	No
Secondary	Breath carbon monoxide levels		12 hours post last cigarette	No
Secondary	Salivary cotinine levels		12 hours post last cigarette	No
Secondary	Clinical safety lab tests		Up to 7 days post dose	Yes
Secondary	Assessment of adverse events		Up to 7 days post dose	Yes