Baclofen Effects in Cigarette Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Baclofen; placebo
Intervention MeSH terms: Baclofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nicotine Addiction; fMRI; Baclofen

Summary:

      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.
    

Eligibility criteria:

        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.