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Reduction of Smoking in Cardiac Disease Patients

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00469885
First received: May 3, 2007
Last updated: June 27, 2008
Last verified: June 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Smoking
U.S. FDA Resources

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
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

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

No publications provided

Responsible Party: Anne Joseph, UMN
ClinicalTrials.gov Identifier: NCT00469885     History of Changes
Other Study ID Numbers: P50DA13333-8, NIDA P50 DA13333
Study First Received: May 3, 2007
Last Updated: June 27, 2008
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

Additional relevant MeSH terms:
Cardiovascular Diseases
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013