Phase 2 N=75 Randomized Double-blind Basic Science

Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

Tobacco Use Disorder · Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT01213524 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Preferred Brand Smoke Intake (CO) — 3.30; 3.16; 9.07; 10.54 ppm

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: sensorimotor replacement (Behavioral); 42 mg transdermal nicotine replacement (Drug); Placebo transdermal nicotine (Drug); usual brand smoking (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Brown University
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Preferred Brand Smoke Intake (CO)	3.30; 3.16; 9.07; 10.54; 5.12	—
SECONDARY Questionnaire on Smoking Urges - Brief Scale (QSU-Brief)	32.02; 37.92; 67.08; 74.13; 24.48	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01213524). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.