Baclofen Effects in Cigarette Smokers



Status:Completed
Conditions:Smoking Cessation, Tobacco Consumers
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 60
Updated:12/20/2018
Start Date:March 2013
End Date:June 2017

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Baclofen Effects on Brain and Behavior in Cigarette Smokers

The proposed project will utilize perfusion functional magnetic resonance imaging (fMRI), a
functional candidate gene association approach (of dopaminergic addictions-targeted
polymorphisms), and the dopamine-modulating and gamma-aminobutyric acid (GABA) B receptor
agonist, baclofen, to examine the brain and behavioral responses in smokers to appetitive
smoking reminders (cues that motivate continued smoking and relapse). These studies will
provide a means to identify an appetitive cue-sensitive pharmacologic-responsive
endophenotype. Once brain/behavioral/genetic endophenotypes can be determined prior to
treatment, smoking cessation treatments can be structured to meet individual needs, which
will significantly improve treatment outcome.


Inclusion Criteria:

- Physically healthy, as determined by a comprehensive physical examination and approval
of the study physician males or females who smoke cigarettes, ages 18-60.

- Smoke ≥ 6 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. Examples of medically acceptable methods for this
protocol include barrier (diaphragm or condom) with spermicide, an intrauterine device
(IUD), the Nuvaring, oral contraceptives, levonorgestrel implant, hormonal injection
or complete abstinence.

- Provide voluntary informed consent.

- Must be able to read. [Subjects are required to be able to read because there are
several self-administered measures that they must read, understand and provide written
answers.]

- Intelligence quotient of ≥ 80.

Exclusion Criteria:

- History of head trauma or injury causing loss of consciousness, lasting more than five
(5) minutes or associated with skull fracture or inter-cranial bleeding or abnormal
MRI.

- Current Diagnostic and Statistical Manual-IV (DSM-IV) Axis I diagnoses other than
nicotine dependence.

- Presence of magnetically active irremovable prosthetics, plates, pins, permanent
retainer, bullets, etc. (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.

- History of psychosis.

- Claustrophobia or other medical condition preventing subject from lying in the MRI for
approximately one (1) hour.

- Current diagnosis of or treatment within the last 3 months for alcohol dependence.

- Current use of any smoking cessation treatments such as Zyban, Chantix, Wellbutrin,
patch, gum, inhaler, electronic cigarettes, herbal preparations.

- Vision problems that cannot be corrected with glasses.

- Weight exceeding 300 pounds [Imaging data acquisition is impaired with high weight
individuals].

- History of stroke.
We found this trial at
1
site
Philadelphia, Pennsylvania 19104
Principal Investigator: Teresa R Franklin, Ph.D.
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mi
from
Philadelphia, PA
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