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Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder (BEST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01010204
First Posted: November 9, 2009
Last Update Posted: December 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Mental Health (NIMH)
Pfizer
Information provided by (Responsible Party):
K.N. Roy Chengappa, University of Pittsburgh
  Purpose

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.


Condition Intervention Phase
Smoking Cessation Bipolar Disorder Drug: Varenicline Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by K.N. Roy Chengappa, University of Pittsburgh:

Primary Outcome Measures:
  • 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks [ Time Frame: 12 weeks ]
    To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence at 12 weeks

  • 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks [ Time Frame: 24 weeks ]
    To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence


Secondary Outcome Measures:
  • Participants Experiencing Neuropsychiatric Events [ Time Frame: 24 weeks ]
    Evaluate the safety of varenicline in treatment-emergent hypomania, mania, mixed or depressed episodes or being associated suicidal or aggressive behavior or psychotic symptoms when used as adjunctive treatment in participants with bipolar disorder.


Enrollment: 60
Study Start Date: January 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Varenicline
We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.
Drug: Varenicline
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.
Other Name: Chantix
Placebo Comparator: Placebo
We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.
Drug: Placebo
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.
Other Name: Comparator

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010204


Locations
United States, Pennsylvania
Dubois Regional Medical Center
DuBois, Pennsylvania, United States, 15801
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
K.N. Roy Chengappa
National Institute of Mental Health (NIMH)
Pfizer
Investigators
Principal Investigator: K.N. Roy Chengappa University of Pittsburgh School of Medicine Department of Psychiatry
  More Information

Publications:
Responsible Party: K.N. Roy Chengappa, Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01010204     History of Changes
Other Study ID Numbers: R21MH087928 ( U.S. NIH Grant/Contract )
First Submitted: November 5, 2009
First Posted: November 9, 2009
Results First Submitted: February 27, 2015
Results First Posted: March 12, 2015
Last Update Posted: December 4, 2017
Last Verified: April 2015

Keywords provided by K.N. Roy Chengappa, University of Pittsburgh:
Varenicline
Chantix
Smoking
Bipolar Disorder

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs