Study of Varenicline (Champix) for Smoking Cessation/Reduction in Patients With Bipolar Disorder

NCT01093937 | Completed DMC

• 1 other identifier: 229/2009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated, expansive and irritable mood, often alternating with periods of significant clinical depression. People with Bipolar Disorder are typically heavy smokers who have difficulty quitting, and this is associated with significant tobacco-related medical illness and death. The proposed study will be a double-blind, placebo-controlled 10-week clinical trial of the safety and efficacy of varenicline (Champix™) in thirty subjects with Bipolar I Disorder. This medication is the latest first-line pharmacotherapy for smoking cessation and has been shown to be efficacious for smoking cessation, but has not yet been systematically studied in persons with Bipolar Disorder.

Conditions

Nicotine Dependence

Keywords

Bipolar disorder; Bipolar-I; Varenicline; Champix; Chantix; Nicotine; Nicotinic receptor; Nicotinic receptor dysregulation; Dopamine; Acetylcholine; Cigarette; Smoking; Tobacco; Dependence; Neuropsychological function

Outcome Measures

Primary Outcomes (2)

• Safety

  Medical and psychiatric evaluation

  Baseline (week 0), Weeks 1-9, End of trial (Week 10)

• Smoking cessation

  Medical and psychiatric evaluation

  End of trial (Week 10)

Interventions

varenicline DRUG

One to four 0.5 mg capsules (0.5-2.0 mg) orally per day for ten weeks.

Also known as: Champix, Chantix

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Structured Clinical Interview (SCID) derived DSM-IV diagnoses of Bipolar Disorder (Type I or II), and Nicotine Dependence
• Young Mania Rating Scale Total Score \<12 at study entry
• HAM-D 17-Item Score \>5 and \<24 at study entry
• Fagerstrom Test for Nicotine Dependence (FTND) score of 5 or higher
• Be able to provide informed consent to participate in this study as judged by clinical evaluation, and scoring at least 80% on a post-consent "test"
• Smoking at least 10 cigarettes per day (confirmed by an expired breath CO level \>10 ppm and a plasma cotinine level \>150 ng/ml at baseline)
• Be motivated to quit smoking within 30 days of initial evaluation, as assessed by a score of 7 or higher on the Contemplation Ladder assessment tool
• On a stable dose of a mood stabilizer for at least 1 month (e.g. lithium, valproate, carbamazepine, atypical antipsychotic)
• Judged by the study psychiatrists and/or trained psychiatric clinicians to be in remission from active manic, hypomanic, major depressive and psychotic symptoms based on a clinical interview and SCID-IV ≥1 month prior to study enrollment

You may not qualify if:

• Meet criteria for current abuse or dependence for any other alcohol or illicit substance within the past 3 months of study enrollment
• Current evidence by SCID-IV and clinical evaluation of suicidality, homicidality or psychosis
• Meet DSM-IV criteria for current major depression at the time of baseline evaluation
• A history of hypersensitivity or other known adverse reactions (e.g. hyperstimulation, severe agitation) to varenicline.
• Serious medical conditions (i.e. a history of severe cardiac, renal or hepatic disease, diabetes mellitus or thyroid abnormalities)
• EKG abnormalities
• Prescription of Nicotine Replacement Therapies (NRTs) including patches, gum, lozenges or inhalers
• Prescription of monoamine oxidase inhibitors (MAO-I's) including selegiline or moclobemide
• Prescription of varenicline
• Prescription of bupropion SR
• The presence of manic, mixed manic or hypomanic symptoms in the past one month prior to study enrollment.
• A lifetime history of antidepressant-induced mania or hypomania
• A history of suicidal ideation while taking antidepressants

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Canadian Tobacco Control Research Initiative: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (1)

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

  PMID: 37142273 DERIVED

Related Links

• Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating Centre

MeSH Terms

Conditions

Tobacco Use Disorder; Bipolar Disorder; Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Tony P George, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: March 26, 2010
• Study Start: November 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 23, 2011

Record last verified: 2011-06

Locations

CA (1)