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

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Mount Sinai Health System

Status and phase

Terminated
Phase 4

Conditions

Nicotine Addiction

Treatments

Other: Scheduled Gradual Reduction + Varenicline
Other: Basic Advice + Varenicline
Other: Scheduled Gradual Reduction + Placebo Drug
Other: Basic Advice + Placebo Drug

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01772641
5R34DA031327-02 (U.S. NIH Grant/Contract)
GCO 10-0879

Details and patient eligibility

About

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.

Full 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).

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

32 participants in 4 patient groups, including a placebo group

Scheduled Gradual Reduction + Varenicline
Experimental group
Description:
Participants will be given the behavioral intervention of Scheduled Gradual Reduction along with the smoking cessation drug, Varenicline.
Treatment:
Other: Scheduled Gradual Reduction + Varenicline
Scheduled Gradual Reduction + Placebo Drug
Experimental group
Description:
Participants will be given the behavioral intervention, SGR, along with a placebo drug matching the schedule of the VN group.
Treatment:
Other: Scheduled Gradual Reduction + Placebo Drug
Basic Advice + Varenicline
Experimental group
Description:
Participants will be given basic advice about quitting smoking along with the smoking cessation drug Varenicline
Treatment:
Other: Basic Advice + Varenicline
Basic Advice + Placebo Drug
Placebo Comparator group
Description:
Participants will be given basic advice along with a placebo drug matching the schedule of the VN group.
Treatment:
Other: Basic Advice + Placebo Drug

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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