A Smoking Intervention Study Using Scheduled Gradual Reduction With Varenicline to Help With Cessation
Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nicotine Addiction
Intervention: Scheduled Gradual Reduction + Varenicline (Other); Scheduled Gradual Reduction + Placebo Drug (Other); Basic Advice + Varenicline (Other); Basic Advice + Placebo Drug (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: Icahn School of Medicine at Mount Sinai Official(s) and/or principal investigator(s): Joel Erblich, Ph.D, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai
Overall contact: Alexandra Michalowski, BA, Phone: 212-824-7820, Email: alexandra.michalowski@mssm.edu
Summary
This study has three main aims. Aim 1: To provide initial data on the efficacy of combined
Scheduled Gradual Reduction (SGR) and Varenicline (VN) for smoking cessation, by assessing
abstinence and levels of smoking at 2 time points (4 and 12 weeks post quit). Aim 2: To
explore the possibility that SGR+VN will be particularly efficacious among smokers with
higher background levels of Cue Reactivity (CR), as assessed at the start of the study,
using a classic experimental smoking CR paradigm. Aim 3: To explore possible mechanisms
underlying the effects of SGR+VN, by assessing potential mediators (i. e., self-efficacy,
cue-induced cravings) of treatment effects.
Clinical Details
Official title: A Combination of Scheduled Reduced Smoking With Varenicline to Enhance Cessation
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Comparison of Prolonged Abstinence
Secondary outcome: Comparison of Continuous AbstinenceComparison of Survival
Detailed description:
Smoking remains an intransigent public health concern. There is ample evidence that
non-pharmacological factors, such as environmental triggers (e. g., sight or smell of a
cigarette), can give rise to strong classically-conditioned urges to smoke (termed
'cue-reactivity' [CR]), and that exposure to smoking cues can contribute to cessation
failure. One promising intervention that may address CR is scheduled smoking with gradual
reduction (SGR). Under SGR, individuals smoke only at fixed intervals, and over several
weeks, systematically decrease their cigarettes consumed each day. The approach is
postulated to: 1) provide 'practice' coping with environmentally-triggered cravings that
occur during the inter-cigarette intervals, yielding increased self-efficacy to quit, and 2)
weaken the associations between cues and smoking. Accumulating evidence has also shown that
the smoking cessation drug, varenicline (VN), substantially ameliorates cravings and
enhances cessation, significantly outperforming other drugs. Interestingly, recent animal
research suggests that VN may operate at least partially by dampening conditioned drug
cravings. A combination therapy consisting of SGR+VN might thus lead to significantly
enhanced cessation, simultaneously attacking cravings using both pharmacological and
non-pharmacological approaches. Because the beneficial effects of SGR and VN may be at least
partially due to enhanced management of conditioned cravings, it is possible that that they
will be particularly efficacious for smokers with high levels of CR. Using both laboratory
experimental techniques and a prospective intervention design in this R34 application, we
propose to provide initial data to: 1) test the hypothesis that a combination of SGR+VN will
enhance cessation, 2) explore the possibility that SGR and VN might be particularly
efficacious among smokers with higher levels of CR, and 3) explore potential mechanisms
underlying treatment effects. Findings from this study would set the stage for larger
efficacy and effectiveness trials of SGR alone and in conjunction with VN, as well as
efforts to target SGR and/or VN toward the subgroups that would benefit the most (e. g.,
smokers with high levels of CR, carriers of specific smoking-related genotypes).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Current cigarette smoker
- Averages at least 10 cigarettes/day for 5 or more years
- DSM-IV diagnosis of Nicotine Dependence
- Breath carbon monoxide > 6 ppm
- Motivated to quit: score > 8 on Contemplation Ladder
- Age > 18 years
Exclusion Criteria:
- Current illicit substance use
- Other tobacco use (e. g., cigar, pipe)
- History of psychosis
- Past or current cardiovascular disease
- Impaired renal functioning
- Pregnancy
- Nursing
- Current treatment for smoking cessation
- Clinically significant depressive symptoms (CES-D > 16)
- Current suicidal ideation
Locations and Contacts
Alexandra Michalowski, BA, Phone: 212-824-7820, Email: alexandra.michalowski@mssm.edu
Icahn School of Medicine at Mount Sinai, New York, New York 10029, United States; Recruiting Joel Erblich, Ph.D, Principal Investigator
Additional Information
Starting date: December 2012
Last updated: April 16, 2015
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