Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

Biological and Behavioral Mechanisms of Smoking in Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Tobacco Use Disorder
• Intervention / Treatment: Behavioral: sensorimotor replacement; Drug: 42 mg transdermal nicotine replacement; Drug: Placebo transdermal nicotine; Other: usual brand smoking

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University, 121 South Main Street

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active nicotine replacement (NRT) + denicotinized cigarettes; 42 mg nicotine replacement plus sensorimotor replacement	Behavioral: sensorimotor replacement; denicotinized cigarettes; Drug: 42 mg transdermal nicotine replacement; 2 21-mg nicotine patches
Active Comparator: Placebo NRT + denicotinized cigarettes; inactive transdermal patches plus sensorimotor replacement	Behavioral: sensorimotor replacement; denicotinized cigarettes; Drug: Placebo transdermal nicotine; 2 placebo patches matched to 21-mg nicotine patches
Active Comparator: Active NRT + no cigarettes; 42 mg nicotine replacement with no sensorimotor replacement	Drug: 42 mg transdermal nicotine replacement; 2 21-mg nicotine patches
Placebo Comparator: Placebo NRT + No cigarettes; Double placebo: No nicotine or sensorimotor replacement	Drug: Placebo transdermal nicotine; 2 placebo patches matched to 21-mg nicotine patches
Active Comparator: usual brand smoking; positive control: usual brand smoking	Other: usual brand smoking; participant smokes usual brand of cigarette

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Jennifer Tidey, Ph.D., Brown University

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: October 1, 2010
• First Submitted That Met QC Criteria: October 1, 2010
• First Posted (Estimate): October 4, 2010

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: September 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: craving; nicotine; comorbidity; dual-diagnosis
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: R01DA014002 (U.S. NIH Grant/Contract)