Study Stopped
difficulty recruiting and retaining participants
A Smoking Intervention Study Using Scheduled Gradual Reduction With Varenicline to Help With Cessation
A Combination of Scheduled Reduced Smoking With Varenicline to Enhance Cessation
2 other identifiers
interventional
32
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 17, 2013
CompletedFirst Posted
Study publicly available on registry
January 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedMarch 16, 2016
March 1, 2016
1.1 years
January 17, 2013
March 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of Prolonged Abstinence
Prolonged Abstinence from 12 weeks post-quit as compared to 4 weeks post-quit
up to12 weeks post-quit
Secondary Outcomes (2)
Comparison of Continuous Abstinence
30 days post-quit and 30 days post end-of-treatment
Comparison of Survival
30 days post-quit and 30 days post end-of-treatment
Study Arms (4)
Scheduled Gradual Reduction + Varenicline
EXPERIMENTALParticipants will be given the behavioral intervention of Scheduled Gradual Reduction along with the smoking cessation drug, Varenicline.
Scheduled Gradual Reduction + Placebo Drug
EXPERIMENTALParticipants will be given the behavioral intervention, SGR, along with a placebo drug matching the schedule of the VN group.
Basic Advice + Varenicline
EXPERIMENTALParticipants will be given basic advice about quitting smoking along with the smoking cessation drug Varenicline
Basic Advice + Placebo Drug
PLACEBO COMPARATORParticipants will be given basic advice along with a placebo drug matching the schedule of the VN group.
Interventions
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.
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.
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.
Participants will receive informational pamphlets with advice about quitting smoking. Additionally, they will take placebo pills matching the schedule of the VN group.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Related Publications (1)
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
PMID: 37142273DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joel Erblich, Ph.D
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 17, 2013
First Posted
January 21, 2013
Study Start
December 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
March 16, 2016
Record last verified: 2016-03