Reduction of Smoking in Cardiac Disease Patients - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00469885

Purpose

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

Condition	Intervention	Phase
Cardiovascular Disease Tobacco Use Disorder	Drug: Nicotine replacement Behavioral: Motivational counseling	Phase II

MedlinePlus related topics: Smoking

Drug Information available for: Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Harm Reduction Treatment for Smokers With Cardiovascular Disease {Reduction of Smoking in Cardiovascular Disease Patients (ROSCAP)}

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Number of cigarettes per day [ Time Frame: 6 months ] [ Designated as safety issue: No ]
ASCVD health changes [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Days of abstinence from cigarettes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of quit attempts [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Withdrawal symptoms [ Time Frame: ongoing through 6 months ] [ Designated as safety issue: No ]

Enrollment:	152
Study Start Date:	January 2001
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Usual care	Behavioral: Motivational counseling No drugs
2 Reduction	Drug: Nicotine replacement For reduction

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469885

Locations

United States, Minnesota
Univerisity of Minnesota
Minneapolis, Minnesota, United States, 55414
Univeristy of Minnesota
Minneapolis, Minnesota, United States, 55404

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Anne Joseph, MD

Veteran's Administration Hospital

More Information

Responsible Party:	UMN ( Anne Joseph )
Study ID Numbers:	P50DA13333-8, NIDA P50 DA13333
Study First Received:	May 3, 2007
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00469885
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):

Smoking cessation
cardiovascular disease
smoking reduction
nicotine replacement

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Heart Diseases
Nicotine

Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Autonomic Agents
Nicotinic Agonists
Physiological Effects of Drugs

Ganglionic Stimulants
Cardiovascular Diseases
Peripheral Nervous System Agents
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009