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Effect of Smoking Exposure on Smoking Relapse Following Brief Abstinence - 2

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ClinicalTrials.gov Identifier: NCT00136838
Recruitment Status : Completed
First Posted : August 29, 2005
Results First Posted : May 11, 2016
Last Update Posted : June 18, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Adam Bisaga, New York State Psychiatric Institute

Study Description
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Brief Summary:

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, the investigators will develop a laboratory model of relapse to cigarette use in nicotine dependent volunteers.


Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Behavioral: Neutral or active cigarette cues Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Smoking Exposure on Tobacco Self-Administration Following Brief Abstinence
Study Start Date : October 2001
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006
Arms and Interventions
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Arm Intervention/treatment
Experimental: Neutral Cue first, then Active Cue

Each participant receives two consecutive interventions.

  1. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue
  2. Cigarette cue: during this phase of treatment participants were presented with active cigarette cue.
 Behavioral: Neutral or active cigarette cues
Packets of cigarettes or cigarette smoke.
Experimental: Active Cue first, then Neutral Cue

Each participant receives two consecutive interventions.

  1. Cigarette cue: during this phase of treatment participants were presented with active cigarette cue.
  2. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue
 Behavioral: Neutral or active cigarette cues
Packets of cigarettes or cigarette smoke.


Outcome Measures
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Primary Outcome Measures :
  1. Cigarette Choice After 3 Day Abstinence [ Time Frame: During Day 4 experimental session ]
    Following 3 days of abstinence participants had an option to smoke cigarettes every 30 minutes for the maximum of 6 choices


Other Outcome Measures:
  1. Craving [ Time Frame: immediately following cue expose ]
    Measure of self-reported craving on a scale of 0-70 (0=no craving; 70= worst possible craving).


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136838


Locations
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United States, New York
Columbia University
New York, New York, United States, 10023
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Adam Bisaga, M.D. New York State Psychiatric Institute
More Information
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Responsible Party: Adam Bisaga, Research Psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00136838    
Other Study ID Numbers: #4725(2)
R01DA017572 ( U.S. NIH Grant/Contract )
R01DA017572-02 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Posted: August 29, 2005    Key Record Dates
Results First Posted: May 11, 2016
Last Update Posted: June 18, 2018
Last Verified: May 2018
Keywords provided by Adam Bisaga, New York State Psychiatric Institute:
tobacco use
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders