Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Biological and Behavioral Mechanisms of Smoking in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213524
• Other study ID #: R01DA014002
• Status: Completed
• Phase: Phase 2
• Start date: September 2005
• Est. completion date: March 2011

Study information

• Verified date: August 2020
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia
• Tobacco Use Disorder

Intervention

Behavioral:
• sensorimotor replacement
denicotinized cigarettes

Drug:
• 42 mg transdermal nicotine replacement
2 21-mg nicotine patches
• Placebo transdermal nicotine
2 placebo patches matched to 21-mg nicotine patches

Other:
• usual brand smoking
participant smokes usual brand of cigarette

Locations

Country	Name	City	State
United States	Brown University, 121 South Main Street	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	90 min
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")	5 hr