Smoking CessationPhase 2NCT00202696
Nalmefene Smoking Cessation Study
A Phase 2 study testing nalmefene in people with Smoking Cessation, run by Somaxon Pharmaceuticals at 1 site in United States.
Trial summary
To determine if nalmefene is safe and effective in smoking cessation. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- nalmefene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Mar 2006
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smokers in good general health self reporting more than 15 cigarettes per day
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center Evaluation of Nalmefene HCl Versus Placebo on Smoking Cessation
To determine if nalmefene is safe and effective in smoking cessation.
Read the detailed description
Single centered, randomized, placebo-controlled,double-blind, outpatient pilot study to evaluate the efficacy, safety and tolerability of 2 doses of nalmefene on smoking cessation.
- Conditions
- Smoking Cessation
- Being tested
- nalmefene, Placebo
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nalmefeneDrug
Nalmefene HCl film-coated tablets administered orally, twice daily, for total daily dosage of 40 or 80 mg, for 5 weeks (following a 2-week titration period).
PlaceboOther
Placebo tablets, administered orally, twice daily for 5 weeks (following a 2-week titration period).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nalmefene 40 mg Receives: Drug: nalmefene |
| 2 | Experimental | Nalmefene 80 mg Receives: Drug: nalmefene |
| 3 | Other | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the efficacy of 2 doses of nalmefene relative to placebo
Secondary outcomes (1)
Evaluate the safety and tolerability of 2 doses of nalmefene
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Somaxon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Philip Jochelson, MD, Study director, Somaxon Pharmaceuticals CMO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202696
- Sponsor's protocol ID
- SP-N0408
- Status last verified
- May 2008
- First submitted
- 12 Sep 2005
- Last updated
- 19 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Evaluation of Nalmefene HCl Versus Placebo on Smoking Cessation
- ClinicalTrials.gov ID
- NCT00202696
- Acronym / sponsor ID
- SP-N0408
- Conditions
- Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Somaxon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 20 Sep 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.
To determine if nalmefene is safe and effective in smoking cessation.
Detailed description
Single centered, randomized, placebo-controlled,double-blind, outpatient pilot study to evaluate the efficacy, safety and tolerability of 2 doses of nalmefene on smoking cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: nalmefeneNalmefene 40 mg |
| 2 | Experimental | Drug: nalmefeneNalmefene 80 mg |
| 3 | Other | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Smokers in good general health self reporting more than 15 cigarettes per day
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| nalmefeneNalmefene HCl film-coated tablets administered orally, twice daily, for total daily dosage of 40 or 80 mg, for 5 weeks (following a 2-week titration period). | Drug | 1, 2 |
| PlaceboPlacebo tablets, administered orally, twice daily for 5 weeks (following a 2-week titration period). | Other | 3 |
Primary outcome
Assess the efficacy of 2 doses of nalmefene relative to placebo
1 secondary outcome
Evaluate the safety and tolerability of 2 doses of nalmefene
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 19 May 2008.
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Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
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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.
Philip Jochelson, MD study director
Somaxon Pharmaceuticals CMO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nalmefene in people with Smoking Cessation, run by Somaxon Pharmaceuticals at 1 site in United States.
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 1 inclusion and 1 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 19 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Assess the efficacy of 2 doses of nalmefene relative to placebo. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2008.