Tobacco Use Disorder
Conditions
Keywords
tobacco use
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.
Interventions
BEHAVIORALNeutral or active cigarette cues
Packets of cigarettes or cigarette smoke.
Sponsors
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
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 * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cigarette Choice After 3 Day Abstinence | 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
| Measure | Time frame | Description |
|---|---|---|
| Craving | immediately following cue expose | Measure of self-reported craving on a scale of 0-70 (0=no craving; 70= worst possible craving). |
Countries
United States
Participant flow
Recruitment details
Twelve participants were recruited through advertisements in local newspapers and flyers.
Participants by arm
| Arm | Count |
|---|---|
| Study Participants This is a within-group study design, all participant who completed the study completed 2 phases of treatment, done in random order, each lasting 5 days and separated by at least 2 weeks. During one of the phases participants were exposed to active cigarette cues (pack of cigarettes, smoke) and during the other phase they were exposed to sham control cues (water bottle and the glass) | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Study Participants |
|---|---|
| Age, Continuous | 31 years STANDARD_DEVIATION 6.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
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
Time frame: During Day 4 experimental session
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Cue | Cigarette Choice After 3 Day Abstinence | 2.50 number of cigarette choices (0-6) | Standard Error 0.63 |
| Neutral Cue | Cigarette Choice After 3 Day Abstinence | 3.67 number of cigarette choices (0-6) | Standard Error 0.58 |
Other Pre-specified
Craving
Measure of self-reported craving on a scale of 0-70 (0=no craving; 70= worst possible craving).
Time frame: immediately following cue expose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Cue | Craving | 58.8 units on a scale (0-70) | Standard Error 3.1 |
| Neutral Cue | Craving | 53.8 units on a scale (0-70) | Standard Error 5.2 |