Schizophrenia, Tobacco Use Disorder
Conditions
Keywords
nicotine, craving, dual-diagnosis, comorbidity
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALsensorimotor replacement
denicotinized cigarettes
DRUG42 mg transdermal nicotine replacement
2 21-mg nicotine patches
DRUGPlacebo transdermal nicotine
2 placebo patches matched to 21-mg nicotine patches
OTHERusual brand smoking
participant smokes usual brand of cigarette
Sponsors
National Institute on Drug Abuse (NIDA)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and outcomes assessor were blind to patch condition (NIC or PLA)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* schizophrenia or no psychiatric illness * 18 and older * men and women * cigarette smokers, 20-50 cigarettes per day * would like to quit someday
Exclusion criteria
* medical conditions excluding transdermal nicotine replacement * pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preferred Brand Smoke Intake (CO) | 90 min | preferred brand smoke intake (breath CO) after 5-hr satiation periods in which nicotine replacement and sensorimotor replacement were provided under double-blind conditions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire on Smoking Urges - Brief Scale (QSU-Brief) | 5 hr | 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) |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the community using newspaper and other community advertisements.
Pre-assignment details
Participants underwent telephone and in-person screening for eligibility.
Participants by arm
| Arm | Count |
|---|---|
| Smokers With Schizophrenia | 37 |
| Non-Psychiatric Controls Smokers without current psychiatric illness | 38 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Baseline | high breath alcohol levels | 1 |
| Baseline | Physician Decision | 1 |
| Baseline | Withdrawal by Subject | 5 |
| Session 2 | Withdrawal by Subject | 5 |
| Session 3 | Withdrawal by Subject | 4 |
| Session 4 | Physician Decision | 1 |
| Session 4 | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Non-Psychiatric Controls | Smokers With Schizophrenia | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 37 Participants | 75 Participants |
| Age, Continuous | 41.7 years STANDARD_DEVIATION 11.7 | 45.4 years STANDARD_DEVIATION 8.2 | 43.6 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment United States | 38 participants | 37 participants | 75 participants |
| Sex: Female, Male Female | 21 Participants | 22 Participants | 43 Participants |
| Sex: Female, Male Male | 17 Participants | 15 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 37 | 3 / 38 |
| serious Total, serious adverse events | 0 / 37 | 0 / 38 |
Outcome results
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
Time frame: 90 min
Population: Participants who completed all conditions and for whom data are available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Very Low Nicotine Content Cigarettes + Nicotine Replacement | Preferred Brand Smoke Intake (CO) | 3.30 ppm | Standard Deviation 8.31 |
| Very Low Nicotine Content Cigarettes + Placebo | Preferred Brand Smoke Intake (CO) | 3.16 ppm | Standard Deviation 10.1 |
| No Cigarettes + Nicotine Replacement | Preferred Brand Smoke Intake (CO) | 9.07 ppm | Standard Deviation 6.95 |
| No Cigarettes + Placebo | Preferred Brand Smoke Intake (CO) | 10.54 ppm | Standard Deviation 7.31 |
| Usual Brand Cigarettes | Preferred Brand Smoke Intake (CO) | 5.12 ppm | Standard Deviation 10.33 |
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)
Time frame: 5 hr
Population: Participants who completed the study and for whom data were available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Very Low Nicotine Content Cigarettes + Nicotine Replacement | Questionnaire on Smoking Urges - Brief Scale (QSU-Brief) | 32.02 mm | Standard Deviation 32.74 |
| Very Low Nicotine Content Cigarettes + Placebo | Questionnaire on Smoking Urges - Brief Scale (QSU-Brief) | 37.92 mm | Standard Deviation 34.94 |
| No Cigarettes + Nicotine Replacement | Questionnaire on Smoking Urges - Brief Scale (QSU-Brief) | 67.08 mm | Standard Deviation 30.33 |
| No Cigarettes + Placebo | Questionnaire on Smoking Urges - Brief Scale (QSU-Brief) | 74.13 mm | Standard Deviation 26.47 |
| Usual Brand Cigarettes | Questionnaire on Smoking Urges - Brief Scale (QSU-Brief) | 24.48 mm | Standard Deviation 26.73 |