Nicotine Addiction Clinical Trial
Official title:
A Combination of Scheduled Reduced Smoking With Varenicline to Enhance Cessation
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.
Status | Terminated |
Enrollment | 32 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of Prolonged Abstinence | Prolonged Abstinence from 12 weeks post-quit as compared to 4 weeks post-quit | up to12 weeks post-quit | No |
Secondary | Comparison of Continuous Abstinence | Continuous Abstinence as compared from 30 days post-quit to 30 days post end-of-treatment | 30 days post-quit and 30 days post end-of-treatment | No |
Secondary | Comparison of Survival | Survival as compared from 30 days post-quit to 30 days post end-of-treatment | 30 days post-quit and 30 days post end-of-treatment | No |
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