Clinical trial NCT01213524: Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia
Official title: Biological and Behavioral Mechanisms of Smoking in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Disorder
Schizophrenia
Keywords: nicotine
craving
dual-diagnosis
comorbidity
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-10-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Preferred Brand Smoke Intake (CO)
timeFrame: 90 min
Secondary outcomes:
measure: Questionnaire on Smoking Urges - Brief Scale (QSU-Brief)
timeFrame: 5 hr
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University, 121 South Main Street
state: Rhode Island
Study officials:
affiliation: Brown University
name: Jennifer Tidey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: