NCT00469885

Brief Summary

This study evaluates the effect of smoking reduction vs usual care (quitting advice only) for individuals with peripheral arterial disease who smoke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

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, 2001

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2007

Completed
Last Updated

January 10, 2017

Status Verified

June 1, 2008

Enrollment Period

4.9 years

First QC Date

May 3, 2007

Last Update Submit

January 9, 2017

Conditions

Cardiovascular DiseaseTobacco Use Disorder

Keywords

Smoking cessationcardiovascular diseasesmoking reductionnicotine replacement

Outcome Measures

Primary Outcomes (4)

  • Number of cigarettes per day

    6 months

  • ASCVD health changes

    6 months

  • Days of abstinence from cigarettes

    6 months

  • Number of quit attempts

    6 months

Secondary Outcomes (1)

  • Withdrawal symptoms

    ongoing through 6 months

Study Arms (2)

1

OTHER

Usual care

Behavioral: Motivational counseling

2

OTHER

Reduction

Drug: Nicotine replacement

Interventions

Nicotine replacementDRUG

For reduction

Also known as: Nicoderm, Nicorrette
2
Motivational counselingBEHAVIORAL

No drugs

Also known as: Behavioral counseling
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be included in the study, participants must have peripheral arterial disease (defined as ankle Brachial Index equal to or less than 0.85 or history of prior revascularization) and they must be daily smokers (defined as at least 1 cigarette, cigar, or tobacco pipe daily).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Univeristy of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

Univerisity of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesTobacco Use DisorderSmoking CessationSmoking Reduction

Interventions

Nicotine Replacement TherapyNicotineBehavior Therapy

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehaviorSmoking

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Anne Joseph, MD

    Veteran's Administration Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 7, 2007

Study Start

January 1, 2001

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

January 10, 2017

Record last verified: 2008-06

Locations

US(2)