Varenicline Treatment in Alcohol and Nicotine Dependent Patients With Schizophrenia

NCT00727103 | Completed Phase 4 DMC

• 1 other identifier: SUNY UMU IRBPHS #5656
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the proposed pilot study is to find out whether varenicline (ChantixTM) treatment decreases alcohol use and smoking in patients with schizophrenia or schizoaffective disorder. Varenicline may also improve cognition (memory and concentration) and negative symptoms (e.g. poor attention, poverty of speech, apathy, affective flattening, anhedonia) in patients with schizophrenia and comorbid nicotine and alcohol dependence.

Conditions

Schizophrenia; Schizoaffective Disorder; Alcohol Dependence; Nicotine Dependence

Keywords

Varenicline; Smoking cessation; Schizophrenia; Schizoaffective disorder; Alcohol dependence; Nicotine dependence

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data.

  8 weeks

Secondary Outcomes (4)

• The outcome measure for smoking cessation effectiveness will be the amount of carbon monoxide in expired air at the end of the treatment phase, relative to data collected at baseline and during treatment.

  8 weeks

• The safety of Varenicline use will be determined by examination of adverse events observed during the course of this investigation, with particular emphasis on comparing the frequency of adverse events in Placebo versus Treatment groups.

  8 weeks

• Improvement in cognition will be assessed using the standardized California Verbal Learning Test (CVLT).

  8 weeks

• Improvement in negative symptoms will be assessed using the PANSS negative score.

  8 weeks

Study Arms (2)

1 Varenicline

ACTIVE COMPARATOR

Varenicline will be dispensed in 0.5 mg (blue capsules containing a 0.5 mg varenicline tablet) and 1 mg (red capsules containing a 1 mg varenicline tablet) capsules taken orally. During the first 3 days of medication, participants will take one blue capsule (0.5 mg tablet) of varenicline daily. If the medication is well-tolerated, the dose will be increased to one blue capsule (0.5 mg) po twice daily for 4 days. On day 8, the dose will be increased again to the standard dosing schedule of 1 red capsule (1 mg) po twice daily. At the end of the 8th week, varenicline will be discontinued.

Drug: Varenicline

2 Placebo

PLACEBO COMPARATOR

Placebo will be dispensed in blue and red color coded capsules. During the first 3 days, participants will take one blue capsule po daily. If the medication is well-tolerated, the dose will be increased to one blue capsule po twice daily for 4 days. On day 8, the patients will take 1 red capsule po twice daily. At the end of the 8th week, placebo will be discontinued.

Drug: Placebo

Interventions

Varenicline DRUG

Varenicline will be dispensed in 0.5 mg and 1 mg tablets taken orally. During the first 3 days of medication, participants will take one 0.5 mg tablet of varenicline daily. If the medication is well-tolerated, the dose will be increased to 0.5 mg po twice daily for 4 days. On day 8, the dose will be increased again to the standard dosing schedule of 1 mg (1 tablet) po twice daily. At the end of the 8th week, varenicline will be discontinued.

Also known as: Chantix

1 Varenicline

Placebo DRUG

Placebo will be dispensed in color-coded capsules. Blue capsules will contain 0.5 mg glucose (placebo), red capsules will contain 1 mg glucose (placebo).

2 Placebo

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, ages 18 to 69, with a DSM-IV diagnosis of Schizophrenia or Schizoaffective Disorder, receiving outpatient psychiatric treatment
• Currently taking antipsychotic medication for at least 4 weeks (medication is prescribed, compliance assessed based on self-report and collateral information)
• Current DSM-IV diagnosis of Nicotine Dependence
• Current DSM-IV diagnosis of Alcohol Dependence
• Subject expresses a desire to cut down or quit smoking and drinking (based on assessment with contemplation ladder)
• An average of at least one pack of cigarettes per day (\>=20 cigarettes/day) over the 7 days prior to intake
• An average of at least 7 drinks over the 7 days prior to intake

You may not qualify if:

• Inability to give adequate informed consent
• Currently taking sustained - release bupropion (Zyban) or receiving any other form of bupropion, such as Wellbutrin or Wellbutrin SR; receiving another form of pharmacological smoking cessation treatment (e.g., nicotine gum or patch); or participating in another structured, formal smoking cessation program.
• Currently taking naltrexone (ReVia), Campral or Antabuse
• Participation in a clinical trial less than 3 months prior to intake
• History of suicide attempt in the past year
• History of hospitalization due to suicidal ideation in the past year
• Suicidal ideation at baseline
• Known allergic reaction to varenicline
• Female patients of childbearing potential who are sexually active, not sterile, and who deny using a form of birth control.
• Female patients who are pregnant or nursing.
• Significant unstable medical problems (e.g. impaired renal function).
• Significant unstable psychiatric disorders.
• Subjects who do not attend all required screening appointments.
• Subjects who have pending legal proceedings whose outcome may lead to incarceration within 3 months of intake.
• Positive urine drug screen for cocaine, opioids or amphetamine at baseline

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Related Publications (2)

• Meszaros ZS, Abdul-Malak Y, Dimmock JA, Wang D, Ajagbe TO, Batki SL. Varenicline treatment of concurrent alcohol and nicotine dependence in schizophrenia: a randomized, placebo-controlled pilot trial. J Clin Psychopharmacol. 2013 Apr;33(2):243-7. doi: 10.1097/JCP.0b013e3182870551.

  PMID: 23422399 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; Psychotic Disorders; Alcoholism; Tobacco Use Disorder; Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Zsuzsa Szombathyne Meszaros, MD, PhD

  SUNY Upstate Medical University, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

• Steven L Batki, MD

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: August 1, 2008
• Study Start: July 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

US (1)