Schizophrenia and Disorders With Psychotic FeaturesPhase 2NCT00218218
Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia
A Phase 2 study testing Transdermal Nicotine Patch and 21 mg transdermal nicotine in people with Schizophrenia and Disorders With Psychotic Features and Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia and Disorders With Psychotic Features, Tobacco Use Disorder, Schizophrenia
- What is being tested?
- Transdermal Nicotine Patch and 21 mg transdermal nicotine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2002to Feb 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smokes between 20 and 50 cigarettes per day
- Diagnosis of schizophrenia or schizoaffective disorder
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Providence VA Medical Center
Providence, Rhode Island, 02908
Brown University
Providence, Rhode Island, 02912
About this study
Official title: Transdermal Nicotine and Bupropion for Smoking in Schizophrenics (Study 1)
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.
Read the detailed 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.
- Being tested
- Transdermal Nicotine Patch, 21 mg transdermal nicotine, placebo patch
- Keywords
- Nicotine Dependence, Tobacco Dependence
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders, Tobacco Use Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal Nicotine PatchDrug
Also called nicotine patch
42 mg transdermal nicotine
21 mg transdermal nicotineDrug
Also called nicotine patch
placebo patchDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Transdermal nicotine, 42 mg Receives: Drug: Transdermal Nicotine Patch |
| 2 | Experimental | Transdermal nicotine, 21 mg Receives: Drug: 21 mg transdermal nicotine |
| 3 | Placebo comparator | placebo patch Receives: Drug: placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking behavior (measured by automated topography)
Measured: after 5 hrs abstinence
Secondary outcomes (3)
Adverse events (measured by self-report throughout the study)
Measured: ongoing
Nicotine withdrawal severity
Measured: after 5 hrs abstinence
Smoking urge
Measured: after 5 hrs withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2002
- Primary completionFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Disorders With Psychotic FeaturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jennifer W. Tidey, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218218
- Sponsor's protocol ID
- NIDA-14002-1
- Other IDs
- R01-14002-1, DPMC
- Status last verified
- Aug 2008
- First submitted
- 16 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Nicotine and Bupropion for Smoking in Schizophrenics (Study 1)
- ClinicalTrials.gov ID
- NCT00218218
- Acronym / sponsor ID
- NIDA-14002-1
- Keywords
- Nicotine Dependence, Tobacco Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Jun 2002
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Transdermal Nicotine PatchTransdermal nicotine, 42 mg |
| 2 | Experimental | Drug: 21 mg transdermal nicotineTransdermal nicotine, 21 mg |
| 3 | Placebo comparator | Drug: placebo patchplacebo patch |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Smokes between 20 and 50 cigarettes per day
- Diagnosis of schizophrenia or schizoaffective disorder
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal Nicotine PatchAlso: nicotine patch42 mg transdermal nicotine | Drug | 1 |
| 21 mg transdermal nicotineAlso: nicotine patch | Drug | 2 |
| placebo patch | Drug | 3 |
Primary outcome
Smoking behavior (measured by automated topography)
Time frame: after 5 hrs abstinence
3 secondary outcomes
Adverse events (measured by self-report throughout the study)
Time frame: ongoing
Nicotine withdrawal severity
Time frame: after 5 hrs abstinence
Smoking urge
Time frame: after 5 hrs withdrawal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer W. Tidey principal investigator
Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transdermal Nicotine Patch and 21 mg transdermal nicotine in people with Schizophrenia and Disorders With Psychotic Features and Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking behavior (measured by automated topography) (time frame: after 5 hrs abstinence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.