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Reduction of Smoking in Cardiac Disease Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00469885
First Posted: May 7, 2007
Last Update Posted: January 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute on Drug Abuse (NIDA)
  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 2

Study Type: Interventional
Study Design: 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)}

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of cigarettes per day [ Time Frame: 6 months ]
  • ASCVD health changes [ Time Frame: 6 months ]
  • Days of abstinence from cigarettes [ Time Frame: 6 months ]
  • Number of quit attempts [ Time Frame: 6 months ]

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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).
  Contacts and Locations
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
  More Information

Responsible Party: Anne Joseph, UMN
ClinicalTrials.gov Identifier: NCT00469885     History of Changes
Other Study ID Numbers: P50DA13333-8
NIDA P50 DA13333
First Submitted: May 3, 2007
First Posted: May 7, 2007
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