Varenicline and Smoking Behavior
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | December 2011 |
| End Date: | November 2015 |
Characterizing a Cue-vulnerable Pharmaco-responsive Endophenotype in Smokers
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.
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.
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.
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