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Effects of Varenicline on Smoking Reminders (VSMK)

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ClinicalTrials.gov Identifier: NCT01524627
Recruitment Status : Completed
First Posted : February 2, 2012
Results First Posted : August 17, 2017
Last Update Posted : August 17, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: Varenicline Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Characterizing a Cue-vulnerable Pharmaco-responsive Endophenotype in Smokers
Study Start Date : December 2011
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
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.
Other Name: Sugar Pill
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
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.
Other Name: Chantix



Primary Outcome Measures :
  1. Cigarettes Per Day [ Time Frame: last week of treatment (1-8 weeks) ]
    Cigarettes per day at Baseline versus 8 weeks of treatment, placebo-controlled



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524627


Locations
United States, Pennsylvania
University of Pennsylvania Addiction Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Investigators
Principal Investigator: Teresa Franklin, PhD University of Pennsylvania

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01524627     History of Changes
Other Study ID Numbers: 813779
1R01DA029845-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 2, 2012    Key Record Dates
Results First Posted: August 17, 2017
Last Update Posted: August 17, 2017
Last Verified: August 2017

Keywords provided by University of Pennsylvania:
Smokers
fMRI
varenicline

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs