Effect of Smoking Exposure on Tobacco Self-Administration Following Brief Abstinence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Cigarette Choice After 3 Day Abstinence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Neutral or active cigarette cues (Behavioral)
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
Intervention: Neutral or active cigarette cues (Behavioral)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Adam Bisaga
Research Psychiatrist
New York State Psychiatric Institute