Varenicline and Smoking Behavior (VSMK)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by University of Pennsylvania
Sponsor:
Collaborators:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01524627
First received: January 10, 2012
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

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 fMRI 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.


Condition Intervention Phase
Nicotine Dependence
Drug: Varenicline or placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Characterizing a Cue-vulnerable Pharmaco-responsive Endophenotype in Smokers

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Varenilcine and Smoking Behavior - Difference in brain and behavioral responses to smoking cues depending on genetic differences [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
    Genetic differences (DAT 9/10 versus DAT 10/10) will have better treatment outcomes as measured by taking urines that are analyzed for cotinine levels, which is the primary metabolite of nicotine, if they are randomized to varenicline versus placebo.


Estimated Enrollment: 60
Study Start Date: December 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: varenicline versus placebo (sugar pill)
Participants will receive either varenicline or placebo
Drug: Varenicline or placebo
Varenicline or placebo 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.
Active Comparator: varenicline
Subjects will receive either varenicline or placebo
Drug: Varenicline or placebo
Varenicline or placebo 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
  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: NCT01524627

Contacts
Contact: Joshua Shin, BS 215-222-3200 ext 199 Shin_j@mail.trc.upenn.edu
Contact: Julian Bender, BA 215-222-3200 ext 188 Bender_j@mail.trc.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Addiction Treatment Research Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Teresa Franklin, PhD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Teresa Franklin, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01524627     History of Changes
Other Study ID Numbers: 813779, 1R01DA029845-01A1
Study First Received: January 10, 2012
Last Updated: February 14, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Pennsylvania:
Smokers
fMRI
varenicline

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 October 23, 2014