Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia

Brown University

Status and phase: Completed; Phase 2

Conditions: Tobacco Use Disorder; Schizophrenia

Treatments: Drug: 42 mg transdermal nicotine replacement; Other: usual brand smoking; Drug: Placebo transdermal nicotine; Behavioral: sensorimotor replacement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01213524

R01DA014002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

75 participants in 5 patient groups, including a placebo group

Active nicotine replacement (NRT) + denicotinized cigarettes

Active Comparator group

Description:

42 mg nicotine replacement plus sensorimotor replacement

Treatment:

Drug: 42 mg transdermal nicotine replacement

Behavioral: sensorimotor replacement

Placebo NRT + denicotinized cigarettes

Active Comparator group

Description:

inactive transdermal patches plus sensorimotor replacement

Treatment:

Drug: Placebo transdermal nicotine

Behavioral: sensorimotor replacement

Active NRT + no cigarettes

Active Comparator group

Description:

42 mg nicotine replacement with no sensorimotor replacement

Treatment:

Drug: 42 mg transdermal nicotine replacement

Placebo NRT + No cigarettes

Placebo Comparator group

Description:

Double placebo: No nicotine or sensorimotor replacement

Treatment:

Drug: Placebo transdermal nicotine

usual brand smoking

Active Comparator group

Description:

positive control: usual brand smoking

Treatment:

Other: usual brand smoking