About this trial
Smoking remains the single most preventable cause of morbidity and mortality in the United States, accounting for approximately half a million deaths every year. The current study will investigate the efficacy and mechanisms of change of a novel smoking cessation intervention. The current study will thus provide essential information regarding a treatment that has the potential to enhance the efficacy of existing smoking cessation interventions, thereby having a beneficial impact on the public health of the United States.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
at least 18 years of age
smoke at least 5 cigarettes per day
Expired breath carbon monoxide (CO) reading of at least five parts per million
report the intention to quit
Disqualifiers
inability to speak English
presence of a condition that contraindicates use of the nicotine patch
presence of conditions that might interfere with compliance with the protocol or greatly complicate treatment
any acutely life-threatening disease
Trial design
Factorial
Treatments tested in this trial
cognitive-behavioral withdrawal regulation strategies
BehavioralParticipants will generate and refine individualized withdrawal regulation strategies with the aid of a therapist
relaxation strategies
BehavioralParticipants will generate and refine relaxation techniques with the aid of a therapist
early withdrawal exposure
BehavioralExposure to the first 4 hours of abstinence across 4 separate sessions
Treatment groups
Trial outcomes
Primary outcomes
Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
Self reported abstinence from smoking ("no smoking, not even a puff) in the past seven days, biochemically confirmed by a breath carbon monoxide reading of 3 or less
Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
Self reported abstinence from smoking ("no smoking, not even a puff) in the past seven days, biochemically confirmed by a breath carbon monoxide reading of 3 or less
Smoking cessation as evaluated by self-reported, biochemically-confirmed seven-day point-prevalence abstinence
Self reported abstinence from smoking ("no smoking, not even a puff) in the past seven days, biochemically confirmed by a breath carbon monoxide reading of 3 or less
Secondary outcomes
Cessation milestones as determined by the Timeline Followback Interview
1\) Was initial abstinence achieved (was there any day of non-smoking within the first two weeks after the quit date; yes or no)?; 2) latency to lapse (number of days to the first cigarette after the quit day); 3) was there a progression from lapse to relapse (defined as seven consecutive days of smoking; yes or no)?
Cessation milestones as determined by the Timeline Followback Interview
1\) latency to lapse (number of days to the first cigarette after the quit day); 2) was there a progression from lapse to relapse (defined as seven consecutive days of smoking; yes or no)?
Cessation milestones as determined by the Timeline Followback Interview
1\) latency to lapse (number of days to the first cigarette after the quit day); 2) was there a progression from lapse to relapse (defined as seven consecutive days of smoking; yes or no)?
Physical tobacco dependence
Tobacco dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD). The FTCD is a widely used 9-item measure of physical dependence. FTCD scores, computed from the sum of the items, range from 0 to 10, with greater scores indicating greater dependence.
Sponsors and contacts
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University of Alabama at Birmingham
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator