NCT00018161

Brief Summary

This protocol evaluates the efficacy of combining pharmacologic treatments for smoking cessation, entailing the use of the nicotine skin patch with the nicotinic antagonist mecamylamine, with a specific behavioral therapy designed to inhibit the smoking urge.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 1997

Typical duration 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

January 1, 1997

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2001

Completed
Last Updated

January 21, 2009

Status Verified

September 1, 2007

First QC Date

July 3, 2001

Last Update Submit

January 20, 2009

Conditions

Smoking

Keywords

Nicotineaddictioncigarette smoking

Interventions

MecamylamineDRUG
Nicotine PatchDRUG
Cigarette brand switchingBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Smokers, * Ages 18-65, wanted to quit smoking. * Must be in good health * Exclude cardiac disease, hypotensive or hypertensive, skin allergy, glaucoma, prostatic hypertrophy, pregnant women, drug or alcohol abuse, kidney disease.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Veterans Affairs Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

SmokingBehavior, AddictiveCigarette Smoking

Interventions

MecamylamineTobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

BehaviorCompulsive BehaviorImpulsive BehaviorTobacco SmokingTobacco Use

Intervention Hierarchy (Ancestors)

NorbornanesBridged Bicyclo CompoundsBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsTherapeutics

Study Officials

  • Eric C Westman, M.D.

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

July 3, 2001

First Posted

July 5, 2001

Study Start

January 1, 1997

Study Completion

June 1, 2001

Last Updated

January 21, 2009

Record last verified: 2007-09

Locations

US(1)