Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
VA Boston Healthcare System |
---|---|
Information provided by: | VA Boston Healthcare System |
ClinicalTrials.gov Identifier: | NCT00781755 |
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.
Condition | Intervention | Phase |
---|---|---|
Tobacco Use Disorder |
Drug: varenicline Behavioral: Adaptation of Motivational Interviewing |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Phase 4 Study of Treating Schizophrenic Smokers Using Varenicline and Behavioral Intervention: Effects on Craving, Cues and Withdrawal |
Estimated Enrollment: | 30 |
Arms | Assigned Interventions |
---|---|
1: Experimental
VAR-MI: This group will receive 1mg/day varenicline (titrated from .5mg/day) and two sessions of a motivational interviewing platform CBT treatment over the course of two weeks.
|
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.
|
2: Placebo Comparator
PLA-MI: VAR-MI: This group will receive a daily placebo pill and two sessions of a motivational interviewing platform CBT treatment over the course of two weeks.
|
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.
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible participants for this study:
Exclusion Criteria:
Individuals who are not eligible to participate in this study include individuals with:
Other exclusions are:
United States, Massachusetts | |
VA Boston Healthcare System Brockton Medical Center | |
Brockton, Massachusetts, United States, 02301 |
Principal Investigator: | Gary B Kaplan, M.D. | VA Boston Healthcare System |
Study Chair: | Suzy Bird Gulliver, Ph.D. | VISN 17 Center of Excellence for Research on Returning War Veterans |
Study Chair: | Barbara W Kamholz, Ph.D. | VA Boston Healthcare System |
Study Chair: | James Levitt, M.D. | VA Boston Healthcare System |
Responsible Party: | VA Boston Healthcare System/ Boston University School of Medicine ( Gary B. Kaplan, M.D./ Director, Mental Health Service/ Professor of Psychiatry and Pharmacology ) |
Study ID Numbers: | 1988, VABHS IRB Protocol #1988 |
Study First Received: | October 28, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00781755 |
Health Authority: | United States: Food and Drug Administration |
smoking cessation varenicline schizophrenia |
serious mental illness Nicotine addiction Smoking Behavior |
Nicotine polacrilex Schizophrenia Smoking Behavior, Addictive Nicotine |
Mental Disorders Tobacco Use Disorder Substance-Related Disorders Disorders of Environmental Origin |