SmokingPhase 2NCT00109135
A Study to Investigate a Research Drug as an Aid for Smoking Cessation in Chronic Cigarette Smokers (0364-007)
A Phase 2 study testing taranabant in people with Smoking, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of an investigational drug that may help individuals to stop smoking. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- taranabant
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jun 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Psychiatric diagnoses
- Certain cancers
- Patients who use nicotine replacement therapy
- Patients on a diet regimen
About this study
Official title: 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
The purpose of this study is to evaluate the safety and tolerability of an investigational drug that may help individuals to stop smoking.
- Conditions
- Smoking
- Being tested
- taranabant
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taranabantDrug
Also called MK0364
What is being measured
The primary outcome is the main question the study is designed to answer.
Quitting smoking after 8 weeks of treatment by measuring lab values and expired breath CO levels
Measured: after 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2005 (estimated)
- Study startJan 2005
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109135
- Sponsor's protocol ID
- 0364-007
- Other IDs
- 2005_012, MK-0364-007
- Status last verified
- Sep 2015
- First submitted
- 22 Apr 2005
- Last updated
- 25 Sep 2015
- Results posted
- No
Publications
Morrison MF, Ceesay P, Gantz I, Kaufman KD, Lines CR. Randomized, controlled, double-blind trial of taranabant for smoking cessation. Psychopharmacology (Berl). 2010 Apr;209(3):245-53. doi: 10.1007/s00213-010-1790-2. Epub 2010 Feb 27.
PubMed 20191360
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00109135
- Acronym / sponsor ID
- 0364-007
- Conditions
- Smoking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 25 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of an investigational drug that may help individuals to stop smoking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Psychiatric diagnoses
- Certain cancers
- Patients who use nicotine replacement therapy
- Patients on a diet regimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taranabantAlso: MK0364 | Drug | – |
Primary outcome
Quitting smoking after 8 weeks of treatment by measuring lab values and expired breath CO levels
Time frame: after 8 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
- Derived from this study: PubMed 20191360Morrison MF, Ceesay P, Gantz I, Kaufman KD, Lines CR. Randomized, controlled, double-blind trial of taranabant for smoking cessation. Psychopharmacology (Berl). 2010 Apr;209(3):245-53. doi: 10.1007/s00213-010-1790-2. Epub 2010 Feb 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing taranabant in people with Smoking, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quitting smoking after 8 weeks of treatment by measuring lab values and expired breath CO levels (time frame: after 8 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00109135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.