Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

NCT01213524 | Completed Phase 2 Results

• 1 other identifier: R01DA014002
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder; Schizophrenia

Keywords

nicotine; craving; dual-diagnosis; comorbidity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Questionnaire on Smoking Urges - Brief Scale (QSU-Brief)

  5 hr

Study Arms (5)

Active nicotine replacement (NRT) + denicotinized cigarettes

ACTIVE COMPARATOR

42 mg nicotine replacement plus sensorimotor replacement

Behavioral: sensorimotor replacement; Drug: 42 mg transdermal nicotine replacement

Placebo NRT + denicotinized cigarettes

ACTIVE COMPARATOR

inactive transdermal patches plus sensorimotor replacement

Behavioral: sensorimotor replacement; Drug: Placebo transdermal nicotine

Active NRT + no cigarettes

ACTIVE COMPARATOR

42 mg nicotine replacement with no sensorimotor replacement

Drug: 42 mg transdermal nicotine replacement

Placebo NRT + No cigarettes

PLACEBO COMPARATOR

Double placebo: No nicotine or sensorimotor replacement

Drug: Placebo transdermal nicotine

usual brand smoking

ACTIVE COMPARATOR

positive control: usual brand smoking

Other: usual brand smoking

Interventions

sensorimotor replacement BEHAVIORAL

denicotinized cigarettes

Active nicotine replacement (NRT) + denicotinized cigarettes; Placebo NRT + denicotinized cigarettes

42 mg transdermal nicotine replacement DRUG

2 21-mg nicotine patches

Active NRT + no cigarettes; Active nicotine replacement (NRT) + denicotinized cigarettes

Placebo transdermal nicotine DRUG

2 placebo patches matched to 21-mg nicotine patches

Placebo NRT + No cigarettes; Placebo NRT + denicotinized cigarettes

usual brand smoking OTHER

participant smokes usual brand of cigarette

usual brand smoking

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• schizophrenia or no psychiatric illness
• and older
• men and women
• cigarette smokers, 20-50 cigarettes per day
• would like to quit someday

You may not qualify if:

• medical conditions excluding transdermal nicotine replacement
• pregnancy or lactation

Sponsors & Collaborators

• Brown University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Brown University, 121 South Main Street

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Schizophrenia

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Results Point of Contact

• Title: Jennifer Tidey, Ph.D.
• Organization: Brown University

Jennifer_Tidey@brown.edu

401-863-6418

Study Officials

• Jennifer Tidey, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcomes assessor were blind to patch condition (NIC or PLA)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Research)

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 4, 2010
• Study Start: September 1, 2005
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 19, 2020
• Results First Posted: September 9, 2020

Record last verified: 2020-08

Locations

US (1)