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A Study to Investigate a Research Drug as an Aid for Smoking Cessation in Chronic Cigarette Smokers (0364-007)

A Double-Blind, Multicenter, Randomized, Titrated-Dose, Placebo-Controlled, Study of MK0364 (4 mg to 8 mg) in Chronic Cigarette Smokers as an Aid for Smoking Cessation

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00109135
Enrollment
300
Registered
2005-04-25
Start date
2005-01-31
Completion date
2005-06-30
Last updated
2015-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking

Brief summary

The purpose of this study is to evaluate the safety and tolerability of an investigational drug that may help individuals to stop smoking.

Interventions

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Smoking greater than/equal to 10 cigarettes/day for at least 1 year * Laboratory tests that meet the criteria of the study * In overall good health as determined by the investigator

Exclusion criteria

* Psychiatric diagnoses * Certain cancers * Patients who use nicotine replacement therapy * Patients on a diet regimen

Design outcomes

Primary

MeasureTime frame
Quitting smoking after 8 weeks of treatment by measuring lab values and expired breath CO levelsafter 8 weeks of treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026