Reduction of Smoking in Cardiac Disease Patients

Cardiovascular Disease Clinical Trial

Official title:

Harm Reduction Treatment for Smokers With Cardiovascular Disease {Reduction of Smoking in Cardiovascular Disease Patients (ROSCAP)}

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469885
• Other study ID #: P50DA13333-8
• Secondary ID: NIDA P50 DA13333
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2007
• Last updated: January 9, 2017
• Start date: January 2001
• Est. completion date: December 2005

Study information

• Verified date: June 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Tobacco Use Disorder

Intervention

Drug:
• Nicotine replacement
For reduction

Behavioral:
• Motivational counseling
No drugs

Locations

Country	Name	City	State
United States	Univerisity of Minnesota	Minneapolis	Minnesota
United States	Univeristy of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cigarettes per day		6 months	No
Primary	ASCVD health changes		6 months	Yes
Primary	Days of abstinence from cigarettes		6 months	No
Primary	Number of quit attempts		6 months	No
Secondary	Withdrawal symptoms		ongoing through 6 months	No