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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00469885 |
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 |
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Cardiovascular Disease Tobacco Use Disorder |
Drug: Nicotine replacement Behavioral: Motivational counseling |
Phase II |
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)} |
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 |
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1
Usual care
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Behavioral: Motivational counseling
No drugs
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2
Reduction
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Drug: Nicotine replacement
For reduction
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, Minnesota | |
Univerisity of Minnesota | |
Minneapolis, Minnesota, United States, 55414 | |
Univeristy of Minnesota | |
Minneapolis, Minnesota, United States, 55404 |
Principal Investigator: | Anne Joseph, MD | Veteran's Administration Hospital |
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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Smoking cessation cardiovascular disease smoking reduction nicotine replacement |
Nicotine polacrilex Smoking Neurotransmitter Agents Heart Diseases Nicotine Mental Disorders |
Nicotinic Agonists Tobacco Use Disorder Substance-Related Disorders Disorders of Environmental Origin Peripheral Nervous System Agents Cholinergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Tobacco Use Disorder Nicotinic Agonists Physiological Effects of Drugs Disorders of Environmental Origin Cholinergic Agents |
Pharmacologic Actions Mental Disorders Nicotine Autonomic Agents Substance-Related Disorders Ganglionic Stimulants Cardiovascular Diseases Peripheral Nervous System Agents |