Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder
Condition: Smoking Cessation; Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Varenicline; Placebo
Intervention description: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.; Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water.
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Varenicline; Chantix; Smoking; Bipolar Disorder

Summary:

      The investigators' hypothesis is that add-on varenicline will be effective (versus placebo)
      in initiating abstinence from smoking in subjects with stable, euthymic bipolar disorder who
      are motivated to quit smoking within four weeks. This primary outcome will be assessed from
      randomization to 12 weeks or end of the treatment phase of the study. Secondarily, the
      investigators also hypothesize that varenicline will prevent relapse in the subsequent
      12-weeks follow-up non-treatment phase. Furthermore, the investigators plan to test the
      effectiveness of varenicline in reducing nicotine withdrawal symptoms or urges to smoke, as
      well as its safety for use in stable bipolar patients when used as an add-on treatment for
      smoking cessation.

      The investigators plan to test these hypotheses by conducting a randomized,
      placebo-controlled add-on treatment trial of Chantix with 60 recruited subjects diagnosed
      with DSM-IV bipolar disorder for a period of three months. The investigators will follow-up
      with them three months later to evaluate extended abstinence.
    

Eligibility criteria:

        Subject inclusion criteria

          1. DSM IV-TR Bipolar I or II or Bipolar NOS Disorder

          2. Ability to provide written informed consent

          3. Male or Female patients, all races, ages 18 to 65 years inclusive

          4. Negative serum pregnancy test for females of child-bearing potential. Patients must
             agree to one of the following birth control methods: an oral contraceptive agent, an
             intrauterine device (IUD), an implantable contraceptive (e.g., Norplant), or an
             injectable contraceptive (e.g., Depo Provera) for at least 1 month prior to entering
             the study and will continue its use through at least 30 days after the last dose of
             study medication or a barrier method of contraception, e.g., condom and/or diaphragm
             with spermicide while participating in the study through at least 30 days after the
             last dose of study medication or abstinence.

          5. MADRS total scores ≤ 8 (past 4 weeks) (suicidal item, score ≤ 1, past 4 weeks).

          6. Y-MRS scores ≤ 8 (past 4 weeks) irritability, speech content, disruptive, or
             aggressive behavior items score ≤ 3, past 4 weeks)

          7. Stable doses of primary bipolar maintenance medication for at least 8 weeks prior to
             randomization

          8. No psychiatric hospitalization or Emergency Room Visits for psychiatric issues in the
             6-month period prior to randomization

          9. No suicidal attempts or behavior history past 6 months

         10. No aggressive or violent acts or behavior by history past 6 months

        Subject exclusion criteria

          1. Uncontrolled seizure disorders and other neurological disorders including Huntington's
             Chorea, Multiple Sclerosis, Cerebral Palsy, and stroke (cerebrovascular accident,
             CVA).

          2. Current alcohol or other substance abuse or dependence within the last 3 months
             (caffeine will be permitted, nicotine dependence is part of inclusion criteria),
             including a case-by-case evaluation of those who meet remission criteria and who are
             on long-term substance abuse and/or alcohol abuse treatment.

          3. Female patients who are pregnant, lactating or likely to become pregnant in next 6
             months

          4. Uncontrolled diabetes mellitus, asthma, seizure disorder, uncontrolled hypertension,
             (uncontrolled hypertension is defined as Systolic BP > 150 mm or Hg or diastolic BP >
             95 mm or Hg on 2 consecutive BP readings 15 minutes apart at the time of screening) or
             unstable medical illness. Moderate to severe renal disease - moderate renal failure is
             defined as serum Creatinine >1.3 mg/dl in women and > 1.5 mg/dl in men, at the time of
             screening.

          5. Severe dizziness or fainting due to orthostatic blood pressure changes

          6. Known hypersensitivity to varenicline

          7. Current use of cimetidine

          8. Current treatment with heparin, warfarin, or lidocaine

          9. Comorbid psychiatric condition diagnosed within the last three months.

        Subject smoking inclusion criteria

          1. Score of 7 or greater on the Contemplation Ladder, and willing to pick a target quit
             date within the next 4 weeks.

          2. Smoke > 10 cigarettes per day.

          3. Expired breath CO level > 10 ppm at screening and randomization.

          4. No use of smoking cessation medication and/or behavioral treatment for smoking
             cessation in the past three months.

          5. No current use of any nicotine replacement treatment.

          6. Not using any tobacco products other than cigarettes.

          7. No current treatment for smoking cessation (hypnosis, acupuncture, others).

          8. No current use or past treatment failure with varenicline.

          9. No current treatment with bupropion for smoking cessation.