Varenicline and Smoking Behavior (VSMK)
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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 |
- 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 |
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| 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 |
| United States, Pennsylvania | |
| University of Pennsylvania Addiction Treatment Research Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: Teresa Franklin, PhD | |
| 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:
|
Tobacco Use Disorder Substance-Related Disorders Mental Disorders Varenicline Nicotinic Agonists Cholinergic Agonists |
Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013