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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA017572 | U.S. NIH Grant/Contract | View source | |
| R01DA017572-02 | U.S. NIH Grant/Contract | View source | |
| DPMC | Other Identifier | NIDA |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neutral Cue first, then Active Cue | Experimental | Each participant receives two consecutive interventions.
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| Active Cue first, then Neutral Cue | Experimental | Each participant receives two consecutive interventions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neutral or active cigarette cues | Behavioral | Packets of cigarettes or cigarette smoke. |
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| 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 |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Bisaga, M.D. | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10023 | United States |
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Twelve participants were recruited through advertisements in local newspapers and flyers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Neutral Cue First, Then Active Cue | Participants receives two consecutive interventions in random order.
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| FG001 | Active Cue First, Then Neutral Cue | Each participant receives two consecutive interventions in random order.
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention ( 5 Days) |
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| Second Intervention ( 5 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Error | number of cigarette choices (0-6) | During Day 4 experimental session |
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During the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neutral Cue | Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adam Bisaga | New York State Psychiatric Institute | 646-774-6155 | bisagaa@nyspi.columbia.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Other Pre-specified | Craving | Measure of self-reported craving on a scale of 0-70 (0=no craving; 70= worst possible craving). | Posted | Mean | Standard Error | units on a scale (0-70) | immediately following cue expose |
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| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Active Cue | 1.Cigarette cue: during this phase of treatment participants were presented with active cigarette cue. | 0 | 12 | 0 | 12 |
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