Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treating Schizophrenic Smokers: Effects on Craving, Cues and Withdrawal

This study has been withdrawn prior to enrollment.
(Study design was altered such that a treatment component was removed through the VA IRB. We did not and will not begin this clinical trial.)
Sponsor:
Information provided by:
VA Boston Healthcare System
ClinicalTrials.gov Identifier:
NCT00781755
First received: October 28, 2008
Last updated: December 9, 2008
Last verified: December 2008
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Treating Schizophrenic Smokers Using Varenicline and Behavioral Intervention: Effects on Craving, Cues and Withdrawal

Resource links provided by NLM:


Further study details as provided by VA Boston Healthcare System:

Primary Outcome Measures:
  • Reported Smoking Urge and Withdrawal [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Smoking Status [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Mood Ratings [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Arms Assigned Interventions
Experimental: 1
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.
Placebo Comparator: 2
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781755

Locations
United States, Massachusetts
VA Boston Healthcare System Brockton Medical Center
Brockton, Massachusetts, United States, 02301
Sponsors and Collaborators
VA Boston Healthcare System
Investigators
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
  More Information

No publications provided

Responsible Party: Gary B. Kaplan, M.D./ Director, Mental Health Service/ Professor of Psychiatry and Pharmacology, VA Boston Healthcare System/ Boston University School of Medicine
ClinicalTrials.gov Identifier: NCT00781755     History of Changes
Other Study ID Numbers: 1988, VABHS IRB Protocol #1988
Study First Received: October 28, 2008
Last Updated: December 9, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by VA Boston Healthcare System:
smoking cessation
varenicline
schizophrenia
serious mental illness
Nicotine addiction
Smoking Behavior

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Varenicline
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014