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Nicotine DependenceNCT01093937

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

A study testing varenicline in people with Nicotine Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Nicotine Dependence
What is being tested?
varenicline
Type of treatment
Pill or oral medicine
How many people
30 participants
Where
1 siteCanada
Study dates
Nov 2009to Jun 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M5S 2S1

Other trials in Canada

About this study

Official title: A 10-Week Pilot Study of Varenicline (Champix) Versus Placebo for Smoking Cessation/Reduction in Patients With Bipolar Disorder

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.

Read the detailed description

Varenicline (VAR) is a α4β2 central nicotinic acetylcholine receptor (nAChR) partial agonist. It is believed to mimic the effect of nicotine by stimulating nAChRs and releasing sufficient dopamine in order to reduce craving and withdrawal effects. In the past two years since the approval of VAR there have been some increasing concerns about this medication, particularly in psychiatric smokers. Besides the typical side effects of nausea and insomnia, it has been associated with treatment-emergent suicidality, aggression, psychosis, and induction of hypomania or mania.

Study Design:

Thirty nicotine-dependent cigarette smokers with Bipolar I Disorder will be enrolled (N=30). All subjects will be symptomatically stable prior to enrollment, and compliant with their mood-stabilizer medication treatment to minimize the chances of adverse outcomes. The treatment group would receive flexible doses of varenicline (VAR) ranging from one to four capsules (0.5-2.0 mg) orally per day. The control group would receive one to four capsules of placebo VAR (0 mg) orally per day. All subjects would receive weekly Cognitive Behavioral Therapy (CBT) offered in group format to help them deal with tobacco cravings and mood management. The target quit date would be set during Week 3 of the trial. Comprehensive neuropsychological assessment and laboratory testing will be given at baseline and ten weeks;

Hypotheses:

  1. Varenicline will be superior to placebo for smoking cessation outcomes.
  2. Varenicline will be well-tolerated and safe for use in Bipolar I smokers in comparison to placebo.
  3. Varenicline will reduce smoking indices (Carbon monoxide, cotinine) and have minimal effects on psychiatric symptomatology in mood-stabilizer treated Bipolar I smoking patients.
  4. The presence of prefrontal cortical, impulsivity and attentional deficits on the baseline neuropsychological battery will predict smoking cessation treatment failure in Bipolar I smokers.

Significance:

  • This would be the first placebo-controlled clinical trial using varenicline for the treatment of tobacco dependence in people with Bipolar Disorder.
  • There is an immense need for a safe and effective smoking cessation therapy for smokers with bipolar illness. The co-morbidity between the major psychiatric disorders and nicotine dependence has been well established. The prevalence of cigarette smoking in patients with bipolar disorder is approximately 50-70% as compared to ~19% in the Canadian population. Moreover, smokers with Bipolar Disorder suffer to a higher extent from smoking-related illnesses than non-psychiatric smokers.
Being tested
varenicline
Keywords
Bipolar disorder, Bipolar-I, Varenicline, Champix, Chantix, Nicotine, Nicotinic receptor, Nicotinic receptor dysregulation, Dopamine, Acetylcholine, Cigarette, Smoking, Tobacco, Dependence, Neuropsychological function
Medical subject headings
Tobacco Use Disorder, Bipolar Disorder, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vareniclineDrug

    Also called Champix, Chantix

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

    Medical and psychiatric evaluation

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

  2. Smoking cessation

    Medical and psychiatric evaluation

    Measured: End of trial (Week 10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2010 (estimated)
  2. Study startNov 2009
  3. Primary completionFeb 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01093937
Sponsor's protocol ID
229/2009
Status last verified
Jun 2011
First submitted
25 Mar 2010
Last updated
23 Jun 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37142273

Questions about this trial

What is this clinical trial studying?

A study testing varenicline in people with Nicotine Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: Baseline (week 0), Weeks 1-9, End of trial (Week 10)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01093937, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.

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