Varenicline and Smoking Cessation in Schizophrenia

NCT01111149 | Completed Phase 2 Results DMC

• 2 other identifiers: 0904M64601R01DA024674
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

There is a strong association between smoking and schizophrenia with prevalence rates ranging from 74% to 90%, versus a national average of 30% in nonschizophrenic individuals. A number of hypotheses have been proposed to explain the relationship between high smoking rates and schizophrenia, mostly relating to self-medication primarily for the negative symptoms of schizophrenia. Smoking cessation rates among schizophrenic patients are considerably lower than for other psychiatric disorders. The negative health effects of smoking increase the morbidity and mortality in schizophrenic patients. Currently, the efficacy of bupropion HCl in the treatment of smoking by schizophrenic subjects is inconclusive, and there have not been any published studies of the efficacy of varenicline in schizophrenic subjects. As varenicline appears to be a promising treatment in non-psychiatric patients, it would be useful to expand these studies to examine its effects in schizophrenic patients. Identifying effective and safe means of smoking cessation for this vulnerable population has the potential to reduce morbidity and mortality among individuals with schizophrenia.

Conditions

Schizophrenia; Smoking Cessation

Keywords

Schizophrenia; Smoking cessation; Varenicline; Bupropion

Outcome Measures

Primary Outcomes (3)

• Smoking Abstinence - Serum/Urine Measurements

  Measured by blood/urine tests for nicotine and its break-down product cotinine.

  Week 12

• Smoking Abstinence - Number of Cigarettes Smoked

  Number of cigarettes smoked at week 12 of the study by self-report.

  Week 12

• Smoking Abstinence - Exhaled Carbon Monoxide

  Exhaled carbon monoxide as a biochemical verification of smoking abstinence. Values below are for week 12.

  Week 12

Secondary Outcomes (20)

• Reduction in Smoking

  Week 12

• Negative Symptoms of Schizophrenia - SANS

  Week 12

• Impulsivity and Inattention

  Week 12

• Side Effects

  Week 12

• Abstinence-related Symptoms - MNWS and FTND

  Week 12

Study Arms (3)

Sugar Pill

PLACEBO COMPARATOR

Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.

Other: Sugar Pill

Varenicline

EXPERIMENTAL

Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.

Drug: Varenicline

Bupropion HCl

ACTIVE COMPARATOR

Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.

Drug: Bupropion HCl

Interventions

Sugar Pill OTHER

Sugar pill created and masked by the pharmacy to be used as a control.

Sugar Pill

Varenicline DRUG

Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.

Also known as: Chantix

Varenicline

Bupropion HCl DRUG

in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study

Also known as: Wellbutrin, Zyban

Bupropion HCl

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, 18-75 years old
• Diagnosis of schizophrenia or schizoaffective disorder based on Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria
• Smoking at least 10 cigarettes per day
• Weight of at least 100 lbs (45.4 kg)
• Motivation to quit smoking
• Stabilized psychotic symptoms
• Provision of informed consent for testing and treatment

You may not qualify if:

• Serious cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic disorder
• Seizure disorder, recent withdrawal from alcohol or anxiolytics
• History of bulimia nervosa, anorexia nervosa, or dementia
• History of depression, panic, or bipolar disorders
• Pregnancy or lactation
• Prior use of varenicline or bupropion HCl within three months prior to initiation of the study
• Current use of other smoking cessation treatments
• Regular use of non-cigarette tobacco products (\> than once/week)
• Past substance abuse (alcohol or non-nicotine containing drugs) in the preceding 6 months
• Patients with suicidal ideations or plans
• Florid psychosis or increasing psychosis following varenicline or bupropion HCl treatment
• History of, or current, alcohol dependence/abuse
• Current use of monoamine oxidase inhibitors (MAOI)

Sponsors & Collaborators

• University of Minnesota: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Minnesota, University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (4)

• Yousefi MK, Folsom TD, Fatemi SH. A Review of Varenicline's Efficacy and Tolerability in Smoking Cessation Studies in Subjects with Schizophrenia. J Addict Res Ther. 2011 Dec 20;S4(1):3045. doi: 10.4172/2155-6105.S4-001.

  PMID: 22514788 BACKGROUND

• Fatemi SH. Varenicline efficacy and tolerability in a subject with schizophrenia. Schizophr Res. 2008 Aug;103(1-3):328-9. doi: 10.1016/j.schres.2008.05.002. Epub 2008 Jun 24. No abstract available.

  PMID: 18572388 BACKGROUND

• Fatemi SH, Yousefi MK, Kneeland RE, Liesch SB, Folsom TD, Thuras PD. Antismoking and potential antipsychotic effects of varenicline in subjects with schizophrenia or schizoaffective disorder: a double-blind placebo and bupropion-controlled study. Schizophr Res. 2013 May;146(1-3):376-8. doi: 10.1016/j.schres.2013.02.015. Epub 2013 Mar 16. No abstract available.

  PMID: 23507358 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

MeSH Terms

Conditions

Schizophrenia; Smoking Cessation

Interventions

Sugars; Varenicline; Bupropion

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Carbohydrates; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Dr. S. Hossein Fatemi
• Organization: University of Minnesota

fatem002@umn.edu

612-626-3633

Study Officials

• S. Hossein Fatemi, M.D., Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: April 27, 2010
• Study Start: December 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 17, 2014
• Results First Posted: July 3, 2014

Record last verified: 2014-07

Locations

US (1)