CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 75 enrolled
Drug / intervention
42 mg transdermal nicotine replacement +3 moredrug
Likely dose
42 mg transdermal nicotine replacementfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01213524
NCT01213524Phase 2Completed
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Biological and Behavioral Mechanisms of Smoking in Schizophrenia

Brown University·interventional·Posted Oct 4, 2010·Updated Oct 19, 2020

In Brief

A Phase 2 clinical trial evaluating sensorimotor replacement, 42 mg transdermal nicotine replacement, and 2 other interventions for Tobacco Use Disorder and Schizophrenia. Completed, enrolled 75 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use Disorder, Schizophrenia
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 4, 2010
Enrollment StartSep 1, 2005
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 15.7 years ago

Interventions

sensorimotor replacementbehavioral

denicotinized cigarettes

42 mg transdermal nicotine replacementdrug

2 21-mg nicotine patches

Placebo transdermal nicotinedrug

2 placebo patches matched to 21-mg nicotine patches

usual brand smokingother

participant smokes usual brand of cigarette