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

NCT00622752 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2008-06-17

No results posted yet for this study

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.

Conditions

  • Smoking Cessation

Interventions

DRUG

EVT 302, 10 mg

2 X EVT 302, 5 mg tablets

DRUG

placebo

2 X placebo tablets to match EVT 302 5 mg

DRUG

Nicotine replacement therapy (NRT)

NRT patch containing 21 mg of nicotine

DEVICE

NRT placebo

Medically inert plaster cut to match the NRT plaster

Sponsors & Collaborators

  • Evotec Neurosciences GmbH

    lead INDUSTRY

Principal Investigators

  • Alla Radicke, MD · Parexel International GmbH, Clinical Pharmacology Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00622752 on ClinicalTrials.gov