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Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

Primary Purpose

Tobacco Use Disorder, Schizophrenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sensorimotor replacement
42 mg transdermal nicotine replacement
Placebo transdermal nicotine
usual brand smoking
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tobacco Use Disorder focused on measuring nicotine, craving, dual-diagnosis, comorbidity

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brown University, 121 South Main Street

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Active nicotine replacement (NRT) + denicotinized cigarettes

Placebo NRT + denicotinized cigarettes

Active NRT + no cigarettes

Placebo NRT + No cigarettes

usual brand smoking

Arm Description

42 mg nicotine replacement plus sensorimotor replacement

inactive transdermal patches plus sensorimotor replacement

42 mg nicotine replacement with no sensorimotor replacement

Double placebo: No nicotine or sensorimotor replacement

positive control: usual brand smoking

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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")

Full Information

First Posted
October 1, 2010
Last Updated
September 19, 2020
Sponsor
Brown University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01213524
Brief Title
Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia
Official Title
Biological and Behavioral Mechanisms of Smoking in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Schizophrenia
Keywords
nicotine, craving, dual-diagnosis, comorbidity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and outcomes assessor were blind to patch condition (NIC or PLA)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active nicotine replacement (NRT) + denicotinized cigarettes
Arm Type
Active Comparator
Arm Description
42 mg nicotine replacement plus sensorimotor replacement
Arm Title
Placebo NRT + denicotinized cigarettes
Arm Type
Active Comparator
Arm Description
inactive transdermal patches plus sensorimotor replacement
Arm Title
Active NRT + no cigarettes
Arm Type
Active Comparator
Arm Description
42 mg nicotine replacement with no sensorimotor replacement
Arm Title
Placebo NRT + No cigarettes
Arm Type
Placebo Comparator
Arm Description
Double placebo: No nicotine or sensorimotor replacement
Arm Title
usual brand smoking
Arm Type
Active Comparator
Arm Description
positive control: usual brand smoking
Intervention Type
Behavioral
Intervention Name(s)
sensorimotor replacement
Intervention Description
denicotinized cigarettes
Intervention Type
Drug
Intervention Name(s)
42 mg transdermal nicotine replacement
Intervention Description
2 21-mg nicotine patches
Intervention Type
Drug
Intervention Name(s)
Placebo transdermal nicotine
Intervention Description
2 placebo patches matched to 21-mg nicotine patches
Intervention Type
Other
Intervention Name(s)
usual brand smoking
Intervention Description
participant smokes usual brand of cigarette
Primary Outcome Measure Information:
Title
Preferred Brand Smoke Intake (CO)
Description
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
Secondary Outcome Measure Information:
Title
Questionnaire on Smoking Urges - Brief Scale (QSU-Brief)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Tidey, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University, 121 South Main Street
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

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Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

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