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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The objective of this study is to investigate the relative contributions of nicotine replacement and sensorimotor replacement (i.e., smoking denicotinized cigarettes) on abstinence-induced smoking urges, withdrawal-related negative affect, psychiatric symptoms, cognitive task performance and 90-min ad libitum usual-brand smoking behavior in smokers with schizophrenia and non-psychiatric smokers.
This study used a mixed between- and within-subjects design to investigate the separate and combined effects of sensorimotor replacement for smoking (very low nicotine content [VLNC] cigarettes vs. no cigarettes) and transdermal nicotine replacement (42 mg nicotine [NIC] vs. placebo [PLA] patches) in smokers with schizophrenia and control smokers without psychiatric illness. Each session contained a 5-h controlled administration period in which participants underwent the following conditions, in counterbalanced order: VLNC + NIC, VLNC + PLA, no cigarettes + NIC, no cigarettes + PLA, Usual Brand cigarettes + no patches. Next, participants completed measures of cigarette craving, nicotine withdrawal, smoking habit withdrawal, cigarette subjective effects, psychiatric symptoms and cognitive task performance followed by a 90-min period of ad libitum usual-brand smoking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active nicotine replacement (NRT) + denicotinized cigarettes | Active Comparator | 42 mg nicotine replacement plus sensorimotor replacement |
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| Placebo NRT + denicotinized cigarettes | Active Comparator | inactive transdermal patches plus sensorimotor replacement |
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| Active NRT + no cigarettes | Active Comparator | 42 mg nicotine replacement with no sensorimotor replacement |
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| Placebo NRT + No cigarettes | Placebo Comparator | Double placebo: No nicotine or sensorimotor replacement |
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| usual brand smoking | Active Comparator | positive control: usual brand smoking |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sensorimotor replacement | Behavioral | denicotinized cigarettes |
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| Measure | Description | Time Frame |
|---|---|---|
| Preferred Brand Smoke Intake (CO) | preferred brand smoke intake (breath CO) after 5-hr "satiation" periods in which nicotine replacement and sensorimotor replacement were provided under double-blind conditions | 90 min |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire on Smoking Urges - Brief Scale (QSU-Brief) | Measure of cigarette craving in which 10 items were rated on 100-mm visual analogue scales (0 = "no urge at all", 100 = "strongest urge you've ever had") | 5 hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Tidey, Ph.D. | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University, 121 South Main Street | Providence | Rhode Island | 02912 | United States |
Participants underwent telephone and in-person screening for eligibility.
Participants were recruited from the community using newspaper and other community advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | VLNC + NIC | Within-subjects study with 5 conditions that participants underwent in counter-balanced order:
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| ID | Title | Description |
|---|---|---|
| BG000 | Smokers With Schizophrenia | |
| BG001 | Non-Psychiatric Controls | Smokers without current psychiatric illness |
| BG002 |
| 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, Categorical | Count of Participants |
| 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 | ||||||
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| Primary | Preferred Brand Smoke Intake (CO) | preferred brand smoke intake (breath CO) after 5-hr "satiation" periods in which nicotine replacement and sensorimotor replacement were provided under double-blind conditions | Participants who completed all conditions and for whom data are available | Posted | Mean | Standard Deviation | ppm | 90 min |
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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 | Smokers With Schizophrenia |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment | self-report, not related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Tidey, Ph.D. | Brown University | 401-863-6418 | Jennifer_Tidey@brown.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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Within-subjects design study that investigated the separate and combined effects of sensorimotor replacement for smoking (very low nicotine content [VLNC] cigarettes vs. no cigarettes) and transdermal nicotine replacement (42 mg nicotine [NIC] vs. placebo [PLA] patches). Participants were smokers with schizophrenia and equally-heavy smokers without psychiatric disorders. Each participant underwent the following conditions, in counterbalanced order: VLNC + NIC, VLNC + PLA, no cigarettes + NIC, no cigarettes + PLA, usual-brand cigarettes + no patches.
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Participants and outcomes assessor were blind to patch condition (NIC or PLA)
| 42 mg transdermal nicotine replacement | Drug | 2 21-mg nicotine patches |
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| Placebo transdermal nicotine | Drug | 2 placebo patches matched to 21-mg nicotine patches |
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| usual brand smoking | Other | participant smokes usual brand of cigarette |
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| Total |
Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG002 | No Cigarettes + Nicotine Replacement | 5-hr 42 mg nicotine replacement only |
| OG003 | No Cigarettes + Placebo | 5-hr placebo patches only |
| OG004 | Usual Brand Cigarettes | 5-hr use of usual-brand cigarettes |
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| Secondary | Questionnaire on Smoking Urges - Brief Scale (QSU-Brief) | Measure of cigarette craving in which 10 items were rated on 100-mm visual analogue scales (0 = "no urge at all", 100 = "strongest urge you've ever had") | Participants who completed the study and for whom data were available | Posted | Mean | Standard Deviation | mm | 5 hr |
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| 0 |
| 37 |
| 3 |
| 37 |
| EG001 | Non-Psychiatric Controls | Smokers without current psychiatric illness | 0 | 38 | 3 | 38 |
| alcohol detoxification | Nervous system disorders | Systematic Assessment | self-report, not related |
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| suicidality | Psychiatric disorders | Systematic Assessment | self-report, not related |
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| fall requiring stitches | Skin and subcutaneous tissue disorders | Systematic Assessment | self-report, not related |
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| headache | General disorders | Systematic Assessment | self-report, not related |
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| car accident | Social circumstances | Systematic Assessment | self-report, not related |
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