Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia

NCT00554840 | Completed Phase 2 Results DMC

• 1 other identifier: HP-00042225
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifically, The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients. We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support.

Conditions

Cigarette Smoking; Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Change of ExpiredCO Level From Baseline

  End expired carbon monoxide (CO) level change from baseline to determine participants' level of smoking reduction by treatment assignment. Larger negative values represent a greater level of smoking reduction.

  Weekly for 12 weeks

• Level of Nicotine Dependence by Treatment Assignment

  Nicotine dependence was measured using the total score from the Fagerstrom Test for Nicotine Dependence (FTND) assessment. The total score is computed by adding the scores from the five subscales. Total scores range from 1-10, with lower scores representing a smaller degree of nicotine dependence.

  Weekly for 12 weeks

Secondary Outcomes (4)

• Brief Psychiatric Rating Scale (BPRS) - Total Score

  Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.

• Brief Psychiatric Rating Scale (BPRS) - Psychosis Score

  Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.

• Brief Psychiatric Rating Scale (BPRS) - Anxiety/Depression Score

  Baseline (week 0) then again during the Treatment Phase at weeks 1, 2, 4, 8, and 12.

• Side Effects

  Weekly for 12 weeks

Study Arms (2)

varenicline

ACTIVE COMPARATOR

Drug: varenicline

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

varenicline DRUG

Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.

Also known as: chantix, study drug

varenicline

placebo DRUG

At the end of Pre-med week 1, subjects will receive study medication with the target quit date being the following week. Subjects will be randomized to receive either active drug or matching placebo capsules using the following titration schedule: 0.5mg for three days, 0.5mg twice daily for the next four days, then 1mg twice daily for the rest of the treatment phase. Subjects will be evaluated weekly for abstinence through self report, end expired CO and urine dipstick for cotinine.

Also known as: sugar pill

placebo

Eligibility Criteria

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

You may qualify if:

• Age 18-64
• Regular ten cigarette per day smoker for one year
• Nicotine Dependency Score greater than or equal to four
• DSM-IV Diagnosis of Schizophrenia or Schizoaffective disorder
• Psychiatric medication regimen unchanged for at least 90 days
• Psychiatric medication dosage unchanged for at least 30 days

You may not qualify if:

• Psychiatric hospitalization in last 6 months
• Meets criteria for current Major Depressive Disorder or has a score of greater than 10 on the Calgary Depression Scale (see withdrawal criteria)
• Suicide or homicide ideation with a plan in the last six months
• Life time history of suicide attempt
• Has had a diagnosis of Schizophrenia or Schizoaffective disorder for less than three years
• Current treatment with Bupropion SR
• DSM-IV diagnosis of alcohol or substance dependence within last 6 months\*
• DSM-IV diagnosis of alcohol or substance abuse within three months \*
• Pregnancy or lactation in females (+HCG)
• Use of tobacco product other than cigarettes
• Use of nicotine replacements
• Unstable or serious medical condition in last 6 months

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Drug Abuse (NIDA): collaborator

Related Publications (1)

• 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

Cigarette Smoking; Schizophrenia

Interventions

Varenicline; Drug Evaluation; Sugars

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Drug Development; Investigative Techniques; Evaluation Studies as Topic; Carbohydrates

Limitations and Caveats

Larger studies are needed to confirm these encouraging results.

Results Point of Contact

• Title: Elaine Weiner, M.D.
• Organization: Maryland Psychiatric Research Center

eweiner@mprc.umaryland.edu

410-402-7694

Study Officials

• Elaine Weiner, M.D.

  Maryland Psychiatric Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Maryland Psychiatric Research Center, Outpatient Research Program

Study Record Dates

• First Submitted: November 6, 2007
• First Posted: November 7, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2011
• Last Updated: March 18, 2022
• Results First Posted: May 15, 2017

Record last verified: 2022-03