NCT00781755

Treating Schizophrenic Smokers: Effects on Craving, Cues and Withdrawal

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: VA Boston Healthcare System · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tobacco Use Disorder

Interventions

Type	Name	Description
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.

Timeline

• First posted: 2008-10-29
• Last updated: 2015-06-04

Locations

1 site across 1 country: United States