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Reduction of Smoking in Cardiac Disease Patients

Primary Purpose

Cardiovascular Disease, Tobacco Use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nicotine replacement
Motivational counseling
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Disease focused on measuring Smoking cessation, cardiovascular disease, smoking reduction, nicotine replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Sites / Locations

  • Univeristy of Minnesota
  • Univerisity of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

Usual care

Reduction

Outcomes

Primary Outcome Measures

Number of cigarettes per day
ASCVD health changes
Days of abstinence from cigarettes
Number of quit attempts

Secondary Outcome Measures

Withdrawal symptoms

Full Information

First Posted
May 3, 2007
Last Updated
January 9, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00469885
Brief Title
Reduction of Smoking in Cardiac Disease Patients
Official Title
Harm Reduction Treatment for Smokers With Cardiovascular Disease {Reduction of Smoking in Cardiovascular Disease Patients (ROSCAP)}
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the effect of smoking reduction vs usual care (quitting advice only) for individuals with peripheral arterial disease who smoke.
Detailed Description
This study randomly assigns smokers who do not have a quit date set to either a smoking reduction grop or usual care group. The smoking reduction group receives behavioral counseling on smoking reduction and nicotine patch and/or gum to reduce the number of cigarettes smoked per day by at least 50%. The usual care group is given brief advice to quit smoking and referral to local cessation services. 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). Participants complete questionnaires that measure mood, functional ability, smoking history, and motivation to quit smoking. Participants will be followed in this study for up to 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Tobacco Use Disorder
Keywords
Smoking cessation, cardiovascular disease, smoking reduction, nicotine replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Usual care
Arm Title
2
Arm Type
Other
Arm Description
Reduction
Intervention Type
Drug
Intervention Name(s)
Nicotine replacement
Other Intervention Name(s)
Nicoderm, Nicorrette
Intervention Description
For reduction
Intervention Type
Behavioral
Intervention Name(s)
Motivational counseling
Other Intervention Name(s)
Behavioral counseling
Intervention Description
No drugs
Primary Outcome Measure Information:
Title
Number of cigarettes per day
Time Frame
6 months
Title
ASCVD health changes
Time Frame
6 months
Title
Days of abstinence from cigarettes
Time Frame
6 months
Title
Number of quit attempts
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Withdrawal symptoms
Time Frame
ongoing through 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Joseph, MD
Organizational Affiliation
Veteran's Administration Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Univerisity of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States

12. IPD Sharing Statement

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Reduction of Smoking in Cardiac Disease Patients

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