Treating Schizophrenic Smokers: Effects on Craving, Cues and Withdrawal

Tobacco Use Disorder Clinical Trial

Official title:

Phase 4 Study of Treating Schizophrenic Smokers Using Varenicline and Behavioral Intervention: Effects on Craving, Cues and Withdrawal

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00781755
• Other study ID #: 1988
• Secondary ID: VABHS IRB Protoc
• Status: Withdrawn
• Phase: Phase 4
• First received: October 28, 2008
• Last updated: June 3, 2015

Study information

• Verified date: December 2008
• Source: VA Boston Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a clinical research protocol to study the efficacy of combined varenicline (Chantix) and motivational interviewing (MI) for smoking cessation in a sample of smokers who have been diagnosed with schizophrenia or schizoaffective disorder. The study is a double-blind, randomized, controlled, subacute treatment trial of MI plus varenicline (VAR-MI) versus MI plus placebo (PLA-MI). The pharmaceutical treatment will utilize Chantix at a dose of 1 mg/day for a period of two weeks.

The primary goal is to determine if VAR-MI decreases baseline behavioral measures of urge and withdrawal and reduces baseline rates of cigarette consumption. The primary efficacy measures of VAR-MI vs. PLA-MI treatment are: Minnesota Nicotine Withdrawal Scale, Questionnaire for Smoking Urge-brief, number of cigarettes smoked per day in the previous week, CO levels, and Brief Psychiatric Rating Scale and Positive And Negative Symptom Scale scores on the last day of the study. Other primary outcome measures are to determine the effects of VAR-MI and PLA-MI on smoking cue-induced urges in tobacco cue reactivity sessions and reward responsiveness as assessed by a computerized task.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Eligible participants for this study:

• Are between the ages 18-65 years of age

• Are daily cigarette smokers

• Have smoked a minimum of 10 cigarettes per day for at least one year

• Are confirmed smokers as verified by CO

• Have a psychiatric diagnosis of schizophrenia or schizoaffective disorder (any subtype) as determined by the SCID-IV. Participants must have received a stable dose of antipsychotic medication for at least 2 weeks prior to beginning the study. Patients receiving clozapine at 500 mg/day or more must also be receiving anti-seizure prophylaxis. Patients must be determined to be psychiatrically stable at baseline as established by standardized interview and medical review by psychiatrist.

Exclusion Criteria:

Individuals who are not eligible to participate in this study include individuals with:

• Any serious or unstable medical problem in the last 6 months

• Severe renal impairment

• A history of clinically significant allergic reactions to nicotine agonist medications

• Current primary use of tobacco products other than cigarettes

• Breath alcohol level > 0.005 g/l at screening

• Current substance abuse or dependence (besides nicotine)

• Current attempts to quit smoking using any method

• Designation as legally incompetent to sign the informed consent (i.e., have a guardian or have delegated power of attorney to another).

Other exclusions are:

• Current use of medications that might affect the behavioral response to cigarette smoking, including transdermal nicotine or nicotine gum and bupropion - Inability to participate in the screening session due to severe psychosis, severe depression or suicidality, current mania, or an organic mental disorder such as dementia or delirium

• Presence of unstable psychiatric symptoms or clinical deterioration (i.e., unstable psychosis, homicidality, or suicidality) within the last month.

• Females of childbearing potential are eligible if not pregnant or nursing and if they practice effective contraception (oral, injectable, or implantable contraceptives; intrauterine device; or barrier method with spermicide).

• There currently are no known contraindications to the use of varenicline and no identified drug-drug interactions. However, reduced dosage of varenicline is recommended for individuals with severe renal impairment.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• varenicline
.5mg/day for 3 days then titrated to 1.0mg/day for 11 days. A total dosing regimen of 14 days.

Behavioral:
• Adaptation of Motivational Interviewing
2 sessions of behavioral intervention designed to create ambivalence about quitting or plan for a quit attempt if the patient is ready.

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Brockton Medical Center	Brockton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reported Smoking Urge and Withdrawal		2 weeks	No
Secondary	Smoking Status		2 weeks	No
Secondary	Mood Ratings		2 weeks	No