NCT00202696

Brief Summary

To determine if nalmefene is safe and effective in smoking cessation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

May 19, 2008

Status Verified

May 1, 2008

Enrollment Period

6 months

First QC Date

September 12, 2005

Last Update Submit

May 15, 2008

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Assess the efficacy of 2 doses of nalmefene relative to placebo

Secondary Outcomes (1)

  • Evaluate the safety and tolerability of 2 doses of nalmefene

Study Arms (3)

1

EXPERIMENTAL

Nalmefene 40 mg

Drug: nalmefene

2

EXPERIMENTAL

Nalmefene 80 mg

Drug: nalmefene

3

OTHER

Placebo

Other: Placebo

Interventions

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).

12
PlaceboOTHER

Placebo tablets, administered orally, twice daily for 5 weeks (following a 2-week titration period).

3

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smokers in good general health self reporting more than 15 cigarettes per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

nalmefene

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Philip Jochelson, MD

    Somaxon Pharmaceuticals CMO

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

September 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

May 19, 2008

Record last verified: 2008-05

Locations

US(1)