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

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neutral or active cigarette cues
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tobacco Use Disorder focused on measuring tobacco use

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Neutral Cue first, then Active Cue

Active Cue first, then Neutral Cue

Arm Description

Each participant receives two consecutive interventions. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue Cigarette cue: during this phase of treatment participants were presented with active cigarette cue.

Each participant receives two consecutive interventions. Cigarette cue: during this phase of treatment participants were presented with active cigarette cue. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue

Outcomes

Primary Outcome Measures

Cigarette Choice After 3 Day Abstinence
Following 3 days of abstinence participants had an option to smoke cigarettes every 30 minutes for the maximum of 6 choices

Secondary Outcome Measures

Full Information

First Posted
August 25, 2005
Last Updated
May 17, 2018
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00136838
Brief Title
Effect of Smoking Exposure on Smoking Relapse Following Brief Abstinence - 2
Official Title
Effect of Smoking Exposure on Tobacco Self-Administration Following Brief Abstinence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
tobacco use

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neutral Cue first, then Active Cue
Arm Type
Experimental
Arm Description
Each participant receives two consecutive interventions. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue Cigarette cue: during this phase of treatment participants were presented with active cigarette cue.
Arm Title
Active Cue first, then Neutral Cue
Arm Type
Experimental
Arm Description
Each participant receives two consecutive interventions. Cigarette cue: during this phase of treatment participants were presented with active cigarette cue. Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue
Intervention Type
Behavioral
Intervention Name(s)
Neutral or active cigarette cues
Intervention Description
Packets of cigarettes or cigarette smoke.
Primary Outcome Measure Information:
Title
Cigarette Choice After 3 Day Abstinence
Description
Following 3 days of abstinence participants had an option to smoke cigarettes every 30 minutes for the maximum of 6 choices
Time Frame
During Day 4 experimental session
Other Pre-specified Outcome Measures:
Title
Craving
Description
Measure of self-reported craving on a scale of 0-70 (0=no craving; 70= worst possible craving).
Time Frame
immediately following cue expose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Bisaga, M.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States

12. IPD Sharing Statement

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

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