Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jennifer Tidey, Brown University
ClinicalTrials.gov Identifier:
NCT01213524
First received: October 1, 2010
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

The objective of this study is to investigate the relative contributions of nicotine replacement and sensorimotor replacement (i.e., smoking denicotinized cigarettes) on abstinence-induced smoking urges, withdrawal-related negative affect, psychiatric symptoms, cognitive task performance and smoking behavior in smokers with schizophrenia and non-psychiatric smokers.


Condition Intervention Phase
Tobacco Use Disorder
Schizophrenia
Behavioral: sensorimotor replacement
Drug: 42 mg transdermal nicotine replacement
Drug: Placebo transdermal nicotine
Other: usual brand smoking
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Biological and Behavioral Mechanisms of Smoking in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • preferred brand smoking [ Time Frame: 90 min ] [ Designated as safety issue: No ]
    preferred brand smoking is measured after 5-hr "satiation" periods in which nicotine replacement and/or sensorimotor replacement are provided under double-blind conditions


Secondary Outcome Measures:
  • cigarette craving [ Time Frame: 5 hr ] [ Designated as safety issue: No ]
    cigarette craving is measured after 5-hr "satiation" period in which nicotine replacement and/or sensorimotor replacement for smoking are provided under double-blind conditions


Enrollment: 76
Study Start Date: September 2005
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active NRT + denicotinized cigarettes
42 mg nicotine replacement plus sensorimotor replacement
Behavioral: sensorimotor replacement
denicotinized cigarettes
Drug: 42 mg transdermal nicotine replacement
2 21-mg nicotine patches
Active Comparator: Placebo NRT + denicotinized cigarettes
inactive transdermal patches plus sensorimotor replacement
Behavioral: sensorimotor replacement
denicotinized cigarettes
Drug: Placebo transdermal nicotine
2 placebo patches matched to 21-mg nicotine patches
Active Comparator: Active NRT + no cigarettes
42 mg nicotine replacement with no sensorimotor replacement
Drug: 42 mg transdermal nicotine replacement
2 21-mg nicotine patches
Placebo Comparator: Placebo NRT + No cigarettes
Double placebo: No nicotine or sensorimotor replacement
Drug: Placebo transdermal nicotine
2 placebo patches matched to 21-mg nicotine patches
Active Comparator: usual brand smoking
positive control: usual brand smoking
Other: usual brand smoking
participant smokes usual brand of cigarette

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • schizophrenia or no psychiatric illness
  • 18 and older
  • men and women
  • cigarette smokers, 20-50 cigarettes per day
  • would like to quit someday

Exclusion Criteria:

  • medical conditions excluding transdermal nicotine replacement
  • pregnancy or lactation
  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: NCT01213524

Locations
United States, Rhode Island
Brown University, 121 South Main Street
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Jennifer Tidey, Ph.D. Brown University
  More Information

No publications provided

Responsible Party: Jennifer Tidey, Associate Professor (Research), Brown University
ClinicalTrials.gov Identifier: NCT01213524     History of Changes
Other Study ID Numbers: R01DA14002
Study First Received: October 1, 2010
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brown University:
nicotine
craving
dual-diagnosis
comorbidity

Additional relevant MeSH terms:
Schizophrenia
Tobacco Use Disorder
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014