Effect of Smoking Exposure on Smoking Relapse Following Brief Abstinence - 2 - Full Text View

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) New York State Psychiatric Institute
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00136838

Purpose

Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development.

The purpose of this study is to develop a laboratory model for early-stage testing of new and existing treatments for nicotine addiction. Specifically, we will develop a laboratory model of smoking relapse in nicotine dependent volunteers.

Condition	Intervention	Phase
Tobacco Use Disorder	Behavioral: Neutral or active cigarette cues	Phase II

MedlinePlus related topics: Smoking

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Efficacy Study
Official Title:	Effect of Smoking Exposure on Tobacco Self-Administration Following Brief Abstinence

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Smoking Relapse [ Time Frame: Day 5 ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	October 2001
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Packets of cigarettes or cigarette smoke.

Detailed Description:

Tobacco use is the leading preventable cause of death in the United States. Recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development. The goal of this study is to develop a laboratory model for early-stage testing of new and existing compounds for the treatment of tobacco and nicotine addiction. In addition, the objective of this study is to develop a laboratory model of relapse induced by cigarette exposure that would reproduce the psychological and physiological processes that are involved when abstinent individuals progress from initial cigarette smoking (lapse) to a pre-abstinence level of use (relapse). Such a model may be used to study the mechanisms of relapse and to screen medications that might be effective in preventing relapse in treatment seekers.

This study will consist of two phases. Each phase will consist of a 5-day inpatient stay. During the first portion of inpatient stay, participants will not be permitted to smoke. During the second portion of inpatient stay, smoking reinstatement will be modeled, as participant will have opportunity to smoke, following the exposure to tobacco-related or control cues. A variety of behavioral, subjective, physiological, and performance measures will be assessed throughout the study.

Eligibility

Ages Eligible for Study:	21 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

DSM-IV diagnosis of nicotine dependence with psychological dependence
Smokes at least 15 cigarettes per day for the three months prior to enrollment
Currently not seeking treatment for nicotine dependence
Medically healthy, on the basis of physical examination and medical history, vital signs, EKG, and laboratory tests
Females must use an effective method of contraception for the duration of the study

Exclusion Criteria:

DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine
Current Axis I diagnosis or current treatment with psychotropic medications within the 3 months prior to enrollment
History of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders
Currently seeking treatment for nicotine disorders
On parole or probation
History of seizures or head trauma with loss of consciousness, brain contusion, or fracture
History of significant recent violent behavior
Blood pressure greater than 150/90
History of eating disorders
Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136838

Locations

United States, New York
Columbia University
New York, New York, United States, 10023

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

New York State Psychiatric Institute

Investigators

Principal Investigator:

Adam Bisaga, M.D.

New York State Psychiatric Institute

More Information

Responsible Party:	New York State Psychiatric Institute ( Adam Bisaga, MD, Principal Investigator )
Study ID Numbers:	NIDA-17572-2, R01-17572-2, DPMC
Study First Received:	August 25, 2005
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00136838
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Smoking
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 14, 2009