MedTrace Logo

Treating Schizophrenic Smokers: Effects on Craving, Cues and Withdrawal

NCT00781755 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-06-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • VA Boston Healthcare System

    lead FED

Principal Investigators

  • Gary B Kaplan, M.D. · VA Boston Healthcare System

  • Suzy Bird Gulliver, Ph.D. · VISN 17 Center of Excellence for Research on Returning War Veterans

  • Barbara W Kamholz, Ph.D. · VA Boston Healthcare System

  • James Levitt, M.D. · VA Boston Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00781755 on ClinicalTrials.gov