CompletedNCT01524627VSMKUpdated Aug 17, 2017Results posted

Effects of Varenicline on Smoking Reminders

A Phase 2 interventional study of Varenicline and Placebo in Nicotine Dependence, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-08-17.

Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 124
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study summary

Varenicline is the best smoking cessation agent to date; however it is only effective in a subgroup of smokers and is associated with undesirable side effects in other subgroups. To understand the underlying pharmaco-heterogeneity, the proposed project will use perfusion functional magnetic resonance imaging and a functional candidate gene association approach using brain, behavioral, and clinical endpoints in a placebo-controlled study of chronic varenicline administration in smokers. Brain and behavioral responses to smoking cues will be will be significantly greater in 9/10-repeats compared to 10/10-repeats. DAT 9/10-repeat smokers receiving varenicline will have better treatment outcome compared to 10/10-repeats. For the purposes of the clinical trial portion of the study, the change from cigarettes per day at Baseline to the last day of treatment will be reported.

Conditions studied

Nicotine Dependence

Browse trials for

Tobacco Use Disorder 968

Keywords

Smokers
fMRI
varenicline

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 124 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

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

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Physically healthy male or female nicotine dependent patients ages 18-60 without other current drug dependence or psychiatric diagnosis.
Smoke ≥ 10 cigarettes per day for at least 6 months prior to study start date.
Females must be non-pregnant, non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of child bearing potential but practicing a medically acceptable method of birth control from at least 2 weeks prior to screening until 30 days after the last dose of varenicline. Examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine (IUD), oral contraceptives, levonorgestrel implant, or complete abstinence.
Subjects provide voluntary informed consent.
Subjects must read at 8th grade level or higher.

Exclusion criteria

Exclusion Criteria:

History of head trauma or injury causing loss of consciousness, lasting more than three (3) minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI.
Presence of magnetically active prosthetics, plates, pins, permanent retainer, bullets, etc. in patient's body (unless a radiologist confirms that it's presence is unproblematic). An x-ray may be obtained to determine eligibility given the possibility of a foreign body.
Self report of HIV positive and on medication for symptoms: Determined on an individual basis by results from the physical examination and final approval by the study physician.
Symptomatic presence of other hematological disease.
Clinically significant hepatic (liver), renal (kidney), neurological, or endocrinological abnormalities.
History of any cardiovascular event within the last 6 months and any serious/significant cardiovascular event in the subject's life. This will be determined on an individual basis by the study physician.
History of psychosis or seizures.
Use of medications or natural herbs that may cause sedation or may effect the brain systems that are being studied (medication use will be evaluated on a case-by-case basis).
Claustrophobia or other medical condition preventing subject from lying in the MRI for approximately one (1) hour.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 124 participants (actual)

Study arms

Placebo comparator
Control Group
Placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective for Varenicline: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
Drug: Placebo
Active comparator
Varenicline
Varenicline will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
Drug: Varenicline

Interventions

DrugVarenicline
Varenicline will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
Also known as: Chantix
DrugPlacebo
Placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective for Varenicline: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
Also known as: Sugar Pill

What researchers measure

Primary outcomes

Cigarettes Per Day
Cigarettes per day at Baseline versus 8 weeks of treatment, placebo-controlled
Time frame: last week of treatment (1-8 weeks)

Results

Posted Aug 17, 2017

Participant flow

Subjects were recruited from 1/2012-7/2015. Methods used to recruit were flyers, advertisements on public transportation, Craigslist, word of mouth. 596 potential subjects were phone screened, 124 of those successfully consented, 43 were randomized

Participant flow — Overall Study
Milestone	Placebo	Varenicline
Started	22	21
Completed	21	19
Not completed	1	2
Withdrew: Physician decision	0	1
Withdrew: Lost to follow-up	1	1

Outcome measures

PrimaryCigarettes Per Day

Cigarettes per day at Baseline versus 8 weeks of treatment, placebo-controlled

Time frame:: last week of treatment (1-8 weeks)
Reported as:: Mean · cigarettes per day

Cigarettes Per Day
cigarettes per day	Placebo	Varenicline
Baseline	15.7 ± 2.5	14.3 ± 1.8
Following Treatment	9.8 ± 2.6	5.3 ± 1.6

Statistical analysis

Varenicline · t-test, 2 sided · p = 0.0004
Placebo · t-test, 2 sided · p = 0.1

Adverse events

Collected over Collected over 5 years during a subject's week 1-8. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	0/22 (0%)	0/22 (0%)	13/22 (59.1%)
Varenicline	0/21 (0%)	0/21 (0%)	8/21 (38.1%)

Most frequent other events

Most frequent other events
Event	Placebo	Varenicline
Nausea (mild)Gastrointestinal disorders	3/22	7/21
Headache (mild)Nervous system disorders	5/22	0/21
Dizziness (mild)Nervous system disorders	3/22	0/21
Sedation/Drowsiness (mild)Nervous system disorders	3/22	2/21
Nausea (moderate)Gastrointestinal disorders	2/22	2/21
Skin Irritation (mild)Skin and subcutaneous tissue disorders	0/22	2/21
Coughing (mild)Respiratory, thoracic and mediastinal disorders	2/22	0/21
Vivid Dreams (mild)Nervous system disorders	2/22	0/21
Upper Respiratory Infection (moderate)Respiratory, thoracic and mediastinal disorders	2/22	0/21

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo	Varenicline	Total
Mean	40.6 ± 11.1	36.2 ± 11.9	38.1 ± 1.8

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Varenicline	Total
Female	11	12	23
Male	11	9	20

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Placebo	Varenicline	Total
White	6	12	18
Black	15	8	23
Asian	1	0	1
Mixed Race	0	1	1
Hispanic	3	1	4
Non-Hispanic	18	21	39

Region of Enrollment
Region of Enrollment(participants)	Placebo	Varenicline	Total
United States	22	21	43

Study locations

1 site

University of Pennsylvania Addiction Treatment Research Center
Philadelphia, Pennsylvania 19104, United States

Updates

Tracking since Sep 25, 2026

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

Registry details

Key details

Study ID: NCT01524627
Lead sponsor: University of Pennsylvania
Collaborators: National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
Responsible party: Sponsor
First posted: Feb 2, 2012
Start date: Dec 2011
Primary completion: Nov 2015
Completion: Nov 2015
Results posted: Aug 17, 2017
Last update: Aug 17, 2017

Study contacts

Teresa Franklin, PhD

principal investigator · University of Pennsylvania

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Tobacco Use Disorder→

Other studies from this sponsor

University of Pennsylvania

Start the discussion