Treating Schizophrenic Smokers: Effects on Craving, Cues and Withdrawal

Status:

WITHDRAWN

Treating Schizophrenic Smokers: Effects on Craving, Cues and Withdrawal

Lead Sponsor:

VA Boston Healthcare System

Conditions:

Tobacco Use Disorder

Eligibility:

All Genders

18-65 years

Phase:

PHASE4

Brief 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 wit...

Eligibility Criteria

Inclusion

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

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00781755

Last Update

June 4 2015

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