Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder

ClinicalTrials.gov ID: NCT01010204

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01010204
Recruitment status: Completed
Study type: Interventional
Phase: Phase 4
Lead sponsor: K.N. Roy Chengappa; Other
Enrollment: 60 participants

Conditions and interventions

Conditions

Interventions

Varenicline Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 2010 (Type not available)
Primary completion: Mar 2013 (Actual)
Completion: Mar 2013 (Actual)
Last update posted: Dec 4, 2017

2010 – 2013

United States locations

U.S. sites: 2
U.S. states: 1
U.S. cities: 2

Facility	City	State	ZIP	Site status
Dubois Regional Medical Center	DuBois	Pennsylvania	15801	—
Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania	15213	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01010204, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 4, 2017 · Synced Nov 13, 2026