Trials / Completed
CompletedNCT00622752
Effects of EVT 302 With or Without NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of Cigarettes
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Evotec Neurosciences GmbH · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2008-05-01
- Completion
- 2008-05-01
- First posted
- 2008-02-25
- Last updated
- 2008-06-17
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00622752. Inclusion in this directory is not an endorsement.