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

Effect of Smoking Exposure on Tobacco Self-Administration Following Brief Abstinence

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Behavioral: Neutral or active cigarette cues

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neutral Cue first, then Active Cue; 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.	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.; 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	Behavioral: Neutral or active cigarette cues; Packets of cigarettes or cigarette smoke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During Day 4 experimental session

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Craving	Measure of self-reported craving on a scale of 0-70 (0=no craving; 70= worst possible craving).	immediately following cue expose

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: August 25, 2005
• First Submitted That Met QC Criteria: August 25, 2005
• First Posted (Estimate): August 29, 2005

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: tobacco use
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: #4725(2); DPMC (Other Identifier: NIDA); R01DA017572 (U.S. NIH Grant/Contract); R01DA017572-02 (U.S. NIH Grant/Contract)