Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00218218
Other study ID # NIDA-14002-1
Secondary ID R01-14002-1DPMC
Status Completed
Phase Phase 2
First received September 16, 2005
Last updated January 11, 2017
Start date June 2002
Est. completion date February 2005

Study information

Verified date August 2008
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Individuals with schizophrenia are three times as likely to smoke cigarettes as individuals without schizophrenia. While a great deal of research has been focused on smoking cessation programs for healthy individuals, little attention has been directed towards developing an effective smoking cessation treatment for schizophrenics. This project will evaluate the effects of 0, 21 and 42 mg transdermal nicotine on smoking, urge to smoke, and nicotine withdrawal symptoms after 5 hrs abstinence in smokers with schizophrenia and heavy-smoking non-psychiatric control smokers.


Description:

Nicotine is the most commonly abused drug among individuals with schizophrenia; at least 60 percent of schizophrenics smoke cigarettes. Nicotine withdrawal may cause a temporary worsening of schizophrenia symptoms, making it especially difficult for these individuals to quit smoking. Little research has been done on the most effective way to control nicotine use in schizophrenic individuals. Transdermal nicotine and bupropion reduce smoking in non-psychiatric smokers, but little is known about the effects of these medications in smokers with schizophrenia. This project examines the effects of 0, 21 and 42 mg transdermal nicotine on smoking behavior and related subjective effects (urge to smoke and nicotine withdrawal symptoms) in smokers with schizophrenia and non-psychiatric heavy smoking controls. Participants come to the laboratory at 9 am, at which time placebo or nicotine patches are applied. After 5 hrs of smoking abstinence, participants undergo a smoking cue reactivity assessment in which craving and withdrawal symptoms are measured after viewing and handling neutral cues and smoking cues. This is followed by 90 min period in which participants can smoke freely, and smoking topography variables are measured.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date February 2005
Est. primary completion date February 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Smokes between 20 and 50 cigarettes per day

- Diagnosis of schizophrenia or schizoaffective disorder

Exclusion Criteria:

- If enrolled in the control group, must not be diagnosed with a psychiatric disorder

- Currently dependent on alcohol or any drug (other than nicotine)

- Currently trying to quit smoking

- Currently taking bupropion, desipramine, clonidine, buspirone, or doxepin

- History of liver disease

- History of heart attacks or chest pain

- Allergic to adhesives

- Pregnant or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Transdermal Nicotine Patch
42 mg transdermal nicotine
21 mg transdermal nicotine

placebo patch


Locations

Country Name City State
United States Brown University Providence Rhode Island
United States Providence VA Medical Center Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking behavior (measured by automated topography) after 5 hrs abstinence No
Secondary Adverse events (measured by self-report throughout the study) ongoing Yes
Secondary Nicotine withdrawal severity after 5 hrs abstinence No
Secondary Smoking urge after 5 hrs withdrawal No
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A