CompletedNCT01308736Updated Jul 17, 2017Results posted

Varenicline-Aided Cigarette Reduction in Smokers Not Ready to Quit

An interventional study of Varenicline and Placebo pill in Tobacco Use Disorder, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-17.

Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 73
Allocation: Randomized
Ages: 18 Years to 64 Years
Sex: All

Study summary

The investigators will randomize smokers to receive 1) Varenicline + smoking cessation/reduction counseling or 2) Placebo pill + smoking cessation/reduction counseling. Neither the participants nor the research therapists/evaluators will know to which condition (active or placebo pill) the participants have been assigned i.e., a double-blind study). The medication and weekly counseling will occur for 28 days. Participants will complete assessment measures just before the start of treatment (baseline), at the end-of-treatment, at 1-month, 3-month, and at 6-months to determine if there are differences in tobacco use between treatment groups.

Conditions studied

Tobacco Use Disorder

Browse trials for

Tobacco Use Disorder 968

Keywords

tobacco
nicotine
cigarette smoking

In context

Tobacco Use Disorder

968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.

This study's enrollment of 73 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 64 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Must smoke at least 10 cigarettes per day for past 6-months
Must have a working cellular or land-line phone

Exclusion criteria

Exclusion Criteria:

Must not be thinking of quitting in the next 30 days, but be interested in cutting down- Must not regularly (more than 1x/month) use tobacco products other than cigarettes
Must not be currently receiving tobacco dependence treatment counseling
Must not currently be taking varenicline, bupropion, nortriptyline, or any nicotine preparations (gum, lozenge, patch, spray, inhaler)
Must not have positive screen on SCID-I/NP Psychotic Screen
Must have no contraindications to using varenicline, including pregnancy, as measured by Medical History Form

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 73 participants (actual)

Study arms

Active comparator
varenicline
Drug: Varenicline
Placebo comparator
placebo pill
Drug: Placebo pill

Interventions

DrugVarenicline
Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
DrugPlacebo pill
Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.

What researchers measure

Primary outcomes

Cigarette Reduction
50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.
Time frame: At 6-month follow-up

Results

Posted Jul 23, 2015

Participant flow

Participant flow — Overall Study
Milestone	Varenicline	Placebo Pill
Started	31	32
Completed	25	27
Not completed	6	5
Withdrew: Did not attend a single session	6	5

Outcome measures

PrimaryCigarette Reduction

50% reduction in cigarettes per day as compared to baseline. Missing data are assumed to NOT have reduced.

Time frame:: At 6-month follow-up
Reported as:: Number · participants

Cigarette Reduction
participants	Varenicline	Placebo Pill
Cigarette Reduction	10	11

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Varenicline	—	0/31 (0%)	17/31 (54.8%)
Placebo Pill	—	0/32 (0%)	16/32 (50%)

Most frequent other events

Showing 10 of 30

Most frequent other events
Event	Varenicline	Placebo Pill
NauseaGastrointestinal disorders	9/31	5/32
Vivid or Bizarre DreamsGeneral disorders	6/31	4/32
DiarrheaGastrointestinal disorders	3/31	4/32
ConstipationGastrointestinal disorders	3/31	3/32
Dizzy/light-headedGeneral disorders	3/31	0/32
Insomnia or fitful sleepGeneral disorders	1/31	3/32
Cold/Flu symptomsGeneral disorders	1/31	3/32
IrritabilityGeneral disorders	2/31	2/32
Upset stomachGastrointestinal disorders	2/31	0/32
CongestionGeneral disorders	2/31	0/32

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Varenicline	Placebo Pill	Total
Mean	44.03 ± 10.54	44.81 ± 12.14	44.43 ± 11.29

Sex: Female, Male
Sex: Female, Male(Participants)	Varenicline	Placebo Pill	Total
Female	14	17	31
Male	17	15	32

Region of Enrollment
Region of Enrollment(participants)	Varenicline	Placebo Pill	Total
United States	31	32	63

Study locations

1 site

Division of Addiction Psychiatry
New Brunswick, New Jersey 08901, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01308736
Lead sponsor: Rutgers, The State University of New Jersey
Collaborators: Pfizer
Responsible party: Marc L. Steinberg, Ph.D. (Associate Professor, Rutgers University) — Principal investigator
First posted: Mar 4, 2011
Start date: Jan 2011
Primary completion: Feb 2014
Completion: Feb 2014
Results posted: Jul 23, 2015
Last update: Jul 17, 2017

Study contacts

Marc L Steinberg, Ph.D.

principal investigator · University of Medicine and Dentistry of New Jersey

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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