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Reduction of Smoking in Cardiac Disease Patients

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ClinicalTrials.gov Identifier: NCT00469885
Recruitment Status : Completed
First Posted : May 7, 2007
Last Update Posted : January 10, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

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

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Tobacco Use Disorder Drug: Nicotine replacement Behavioral: Motivational counseling Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Harm Reduction Treatment for Smokers With Cardiovascular Disease {Reduction of Smoking in Cardiovascular Disease Patients (ROSCAP)}
Study Start Date : January 2001
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
1
Usual care
Behavioral: Motivational counseling
No drugs
Other Name: Behavioral counseling

2
Reduction
Drug: Nicotine replacement
For reduction
Other Name: Nicoderm, Nicorrette




Primary Outcome Measures :
  1. Number of cigarettes per day [ Time Frame: 6 months ]
  2. ASCVD health changes [ Time Frame: 6 months ]
  3. Days of abstinence from cigarettes [ Time Frame: 6 months ]
  4. Number of quit attempts [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Withdrawal symptoms [ Time Frame: ongoing through 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469885


Locations
United States, Minnesota
Univeristy of Minnesota
Minneapolis, Minnesota, United States, 55404
Univerisity of Minnesota
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Anne Joseph, MD Veteran's Administration Hospital

Responsible Party: Anne Joseph, UMN
ClinicalTrials.gov Identifier: NCT00469885     History of Changes
Other Study ID Numbers: P50DA13333-8
NIDA P50 DA13333
First Posted: May 7, 2007    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: June 2008

Keywords provided by National Institute on Drug Abuse (NIDA):
Smoking cessation
cardiovascular disease
smoking reduction
nicotine replacement

Additional relevant MeSH terms:
Cardiovascular Diseases
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action