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

Tobacco Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136838
• Other study ID #: #4725(2)
• Secondary ID: R01DA017572R01DA
• Status: Completed
• Phase: N/A
• Start date: October 2001
• Est. completion date: June 2006

Study information

• Verified date: May 2018
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• Neutral or active cigarette cues
Packets of cigarettes or cigarette smoke.

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Craving	Measure of self-reported craving on a scale of 0-70 (0=no craving; 70= worst possible craving).	immediately following cue expose
Primary	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