A Phase 2 interventional study of Nicotine replacement and Motivational counseling in Cardiovascular Disease and Tobacco Use Disorder, sponsored by National Institute on Drug Abuse (NIDA). Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-10.
Sponsored by National Institute on Drug Abuse (NIDA) · Phase 2, Interventional, and Treatment
This study evaluates the effect of smoking reduction vs usual care (quitting advice only) for individuals with peripheral arterial disease who smoke.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 152 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →National Institute on Drug Abuse (NIDA) is the lead sponsor of 388 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Usual care
Behavioral: Motivational counseling
Reduction
Drug: Nicotine replacement
For reduction
Also known as: Nicoderm, Nicorrette
No drugs
Also known as: Behavioral counseling
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
Withdrawal symptoms
Time frame: ongoing through 6 months
This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
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National Institute on Drug Abuse (NIDA)