Varenicline Treatment for Smoking Cessation in Patients With Bipolar Disorder

NCT01010204 | Completed Phase 4 Results DMC

• 1 other identifier: R21MH087928
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Smoking Cessation; Bipolar Disorder

Keywords

Varenicline; Chantix; Smoking; Bipolar Disorder

Outcome Measures

Primary Outcomes (2)

• 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks

  To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence at 12 weeks

  12 weeks

• 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks

  To evaluate the efficacy of varenicline treatment added to standard behavioral treatment for smoking abstinence

  24 weeks

Secondary Outcomes (1)

• Participants Experiencing Neuropsychiatric Events

  24 weeks

Study Arms (2)

Varenicline

EXPERIMENTAL

We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.

Drug: Placebo

Interventions

Varenicline DRUG

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.

Also known as: Chantix

Varenicline

Placebo DRUG

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.

Also known as: Comparator

Placebo

Eligibility Criteria

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

You may qualify if:

• DSM IV-TR Bipolar I or II or Bipolar NOS Disorder
• Ability to provide written informed consent
• Male or Female patients, all races, ages 18 to 65 years inclusive
• 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.
• MADRS total scores ≤ 8 (past 4 weeks) (suicidal item, score ≤ 1, past 4 weeks).
• Y-MRS scores ≤ 8 (past 4 weeks) irritability, speech content, disruptive, or aggressive behavior items score ≤ 3, past 4 weeks)
• Stable doses of primary bipolar maintenance medication for at least 8 weeks prior to randomization
• No psychiatric hospitalization or Emergency Room Visits for psychiatric issues in the 6-month period prior to randomization
• No suicidal attempts or behavior history past 6 months
• No aggressive or violent acts or behavior by history past 6 months

You may not qualify if:

• Uncontrolled seizure disorders and other neurological disorders including Huntington's Chorea, Multiple Sclerosis, Cerebral Palsy, and stroke (cerebrovascular accident, CVA).
• Female patients who are pregnant, lactating or likely to become pregnant in next 6 months
• 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.
• Severe dizziness or fainting due to orthostatic blood pressure changes
• Known hypersensitivity to varenicline
• Current use of cimetidine
• Current treatment with heparin, warfarin, or lidocaine
• Comorbid psychiatric condition diagnosed within the last three months.
• Score of 7 or greater on the Contemplation Ladder, and willing to pick a target quit date within the next 4 weeks.
• Smoke \> 10 cigarettes per day.
• Expired breath CO level \> 10 ppm at screening and randomization.
• No use of smoking cessation medication and/or behavioral treatment for smoking cessation in the past three months.
• No current use of any nicotine replacement treatment.
• Not using any tobacco products other than cigarettes.
• No current treatment for smoking cessation (hypnosis, acupuncture, others).

Sponsors & Collaborators

• K.N. Roy Chengappa: lead
• National Institute of Mental Health (NIMH): collaborator
• Pfizer: collaborator

Study Sites (2)

Dubois Regional Medical Center

DuBois, Pennsylvania, 15801, United States

Location

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• Chengappa KN, Perkins KA, Brar JS, Schlicht PJ, Turkin SR, Hetrick ML, Levine MD, George TP. Varenicline for smoking cessation in bipolar disorder: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014 Jul;75(7):765-72. doi: 10.4088/JCP.13m08756.

  PMID: 25006684 RESULT

• 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

• Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

  PMID: 34611902 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Bipolar Disorder; Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: K.N. Roy Chengappa, Md
• Organization: Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center

chengappakn@upmc.edu

412-246-5006

Study Officials

• K.N. Roy Chengappa

  University of Pittsburgh School of Medicine Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 9, 2009
• Study Start: January 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 4, 2017
• Results First Posted: March 12, 2015

Record last verified: 2015-04

Locations

US (2)