A Smoking Intervention Study Using Scheduled Gradual Reduction With Varenicline to Help With Cessation

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Nicotine Addiction

In brief

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.

Key facts

Study ID

NCT01772641

Run by

Icahn School of Medicine at Mount Sinai

People needed

32

Starts

2012-12-01

Expected to finish

2014-01-01

Last updated by the study team

2016-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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