Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Mount Sinai School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joel Erblich, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01772641
First received: January 17, 2013
Last updated: October 22, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Nicotine Addiction
Other: Scheduled Gradual Reduction + Varenicline
Other: Scheduled Gradual Reduction + Placebo Drug
Other: Basic Advice + Varenicline
Other: Basic Advice + Placebo Drug
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Combination of Scheduled Reduced Smoking With Varenicline to Enhance Cessation

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Comparison of Prolonged Abstinence [ Time Frame: up to12 weeks post-quit ] [ Designated as safety issue: No ]
    Prolonged Abstinence from 12 weeks post-quit as compared to 4 weeks post-quit


Secondary Outcome Measures:
  • Comparison of Continuous Abstinence [ Time Frame: 30 days post-quit and 30 days post end-of-treatment ] [ Designated as safety issue: No ]
    Continuous Abstinence as compared from 30 days post-quit to 30 days post end-of-treatment

  • Comparison of Survival [ Time Frame: 30 days post-quit and 30 days post end-of-treatment ] [ Designated as safety issue: No ]
    Survival as compared from 30 days post-quit to 30 days post end-of-treatment


Estimated Enrollment: 192
Study Start Date: December 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Scheduled Gradual Reduction + Varenicline
Participants will be given the behavioral intervention of Scheduled Gradual Reduction along with the smoking cessation drug, Varenicline.
Other: Scheduled Gradual Reduction + Varenicline
Participants will receive a four-week Scheduled Gradual Reduction (SGR) intervention in which participants cut down on the number of cigarettes smoked. This is done through a smoking schedule in which participants smoke a cigarette at given fixed and equal intervals throughout their waking day. Additionally, they will take 0.5 mg of Varenicline (VN) once a day for the first three days, then 0.5 mg twice a day for the next four days, and they will continue for 13 weeks at 1.0 mg twice per day.
Experimental: Scheduled Gradual Reduction + Placebo Drug
Participants will be given the behavioral intervention, SGR, along with a placebo drug matching the schedule of the VN group.
Other: Scheduled Gradual Reduction + Placebo Drug
Participants will receive a four-week Scheduled Gradual Reduction (SGR) intervention in which participants cut down on the number of cigarettes smoked. This is done through a smoking schedule in which participants smoke a cigarette at given fixed and equal intervals throughout their waking day. Additionally, they will take placebo pills matching the schedule of the VN group.
Experimental: Basic Advice + Varenicline
Participants will be given basic advice about quitting smoking along with the smoking cessation drug Varenicline
Other: Basic Advice + Varenicline
Participants will receive informational pamphlets with advice about quitting smoking. Additionally, they will take 0.5 mg of Varenicline (VN) once a day for the first three days, then 0.5 mg twice a day for the next four days, and they will continue for 13 weeks at 1.0 mg twice per day.
Placebo Comparator: Basic Advice + Placebo Drug
Participants will be given basic advice along with a placebo drug matching the schedule of the VN group.
Other: Basic Advice + Placebo Drug
Participants will receive informational pamphlets with advice about quitting smoking. Additionally, they will take placebo pills matching the schedule of the VN group.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772641

Contacts
Contact: Alexandra Michalowski, BA 212-824-7820 alexandra.michalowski@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Principal Investigator: Joel Erblich, Ph.D         
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Joel Erblich, Ph.D Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Joel Erblich, Associate Professor, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01772641     History of Changes
Other Study ID Numbers: GCO 10-0879, 5R34DA031327-02
Study First Received: January 17, 2013
Last Updated: October 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
cigarette
smoking
cessation
varenicline
scheduled reduction
craving

Additional relevant MeSH terms:
Varenicline
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014