Tobacco Use DisorderPhase 2NCT01213524
Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia
A Phase 2 study testing sensorimotor replacement, 42 mg transdermal nicotine replacement and usual brand smoking in people with Tobacco Use Disorder and Schizophrenia, run by Brown University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Schizophrenia
- What is being tested?
- sensorimotor replacement, 42 mg transdermal nicotine replacement and usual brand smoking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- schizophrenia or no psychiatric illness
- 18 and older
- men and women
- cigarette smokers, 20-50 cigarettes per day
- would like to quit someday
Who cannot join
- medical conditions excluding transdermal nicotine replacement
- pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University, 121 South Main Street
Providence, Rhode Island, 02912
About this study
Official title: Biological and Behavioral Mechanisms of Smoking in Schizophrenia
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.
Read the detailed 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.
- Conditions
- Tobacco Use Disorder, Schizophrenia
- Being tested
- sensorimotor replacement, 42 mg transdermal nicotine replacement, Placebo transdermal nicotine, usual brand smoking
- Keywords
- nicotine, craving, dual-diagnosis, comorbidity
- Medical subject headings
- Tobacco Use Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensorimotor replacementBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Active nicotine replacement (NRT) + denicotinized cigarettes | Active comparator | 42 mg nicotine replacement plus sensorimotor replacement Receives: Behavioral: sensorimotor replacement; Drug: 42 mg transdermal nicotine replacement |
| Placebo NRT + denicotinized cigarettes | Active comparator | inactive transdermal patches plus sensorimotor replacement Receives: Behavioral: sensorimotor replacement; Drug: Placebo transdermal nicotine |
| Active NRT + no cigarettes | Active comparator | 42 mg nicotine replacement with no sensorimotor replacement Receives: Drug: 42 mg transdermal nicotine replacement |
| Placebo NRT + No cigarettes | Placebo comparator | Double placebo: No nicotine or sensorimotor replacement Receives: Drug: Placebo transdermal nicotine |
| usual brand smoking | Active comparator | positive control: usual brand smoking Receives: Other: usual brand smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 min
Secondary outcomes (1)
Questionnaire on Smoking Urges - Brief Scale (QSU-Brief)
Measure of cigarette craving in which 10 items were rated on 100-mm visual analogue scales (0 = "no urge at all", 100 = "strongest urge you've ever had")
Measured: 5 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startSep 2005
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- 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
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jennifer Tidey, Brown University
- Investigators
- Jennifer Tidey, Ph.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213524
- Sponsor's protocol ID
- R01DA014002
- Status last verified
- Aug 2020
- First submitted
- 1 Oct 2010
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological and Behavioral Mechanisms of Smoking in Schizophrenia
- ClinicalTrials.gov ID
- NCT01213524
- Acronym / sponsor ID
- R01DA014002
- Conditions
- Tobacco Use Disorder, Schizophrenia
- Keywords
- nicotine, craving, dual-diagnosis, comorbidity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2005
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Posted 9 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active nicotine replacement (NRT) + denicotinized cigarettes | Active comparator | Behavioral: sensorimotor replacement, Drug: 42 mg transdermal nicotine replacement42 mg nicotine replacement plus sensorimotor replacement |
| Placebo NRT + denicotinized cigarettes | Active comparator | Behavioral: sensorimotor replacement, Drug: Placebo transdermal nicotineinactive transdermal patches plus sensorimotor replacement |
| Active NRT + no cigarettes | Active comparator | Drug: 42 mg transdermal nicotine replacement42 mg nicotine replacement with no sensorimotor replacement |
| Placebo NRT + No cigarettes | Placebo comparator | Drug: Placebo transdermal nicotineDouble placebo: No nicotine or sensorimotor replacement |
| usual brand smoking | Active comparator | Other: usual brand smokingpositive control: usual brand smoking |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- schizophrenia or no psychiatric illness
- 18 and older
- men and women
- cigarette smokers, 20-50 cigarettes per day
- would like to quit someday
Key exclusion criteria (2 listed)
- medical conditions excluding transdermal nicotine replacement
- pregnancy or lactation
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 |
|---|---|---|
| sensorimotor replacementdenicotinized cigarettes | Behavioural | Active nicotine replacement (NRT) + denicotinized cigarettes, Placebo NRT + denicotinized cigarettes |
| 42 mg transdermal nicotine replacement2 21-mg nicotine patches | Drug | Active NRT + no cigarettes, Active nicotine replacement (NRT) + denicotinized cigarettes |
| Placebo transdermal nicotine2 placebo patches matched to 21-mg nicotine patches | Drug | Placebo NRT + No cigarettes, Placebo NRT + denicotinized cigarettes |
| usual brand smokingparticipant smokes usual brand of cigarette | Other | usual brand smoking |
Primary outcome
Preferred Brand Smoke Intake (CO)
Time frame: 90 min
preferred brand smoke intake (breath CO) after 5-hr "satiation" periods in which nicotine replacement and sensorimotor replacement were provided under double-blind conditions
1 secondary outcome
Questionnaire on Smoking Urges - Brief Scale (QSU-Brief)
Time frame: 5 hr
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Tidey, Ph.D. principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sensorimotor replacement, 42 mg transdermal nicotine replacement and usual brand smoking in people with Tobacco Use Disorder and Schizophrenia, run by Brown University at 1 site 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 5 inclusion and 2 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 9 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Preferred Brand Smoke Intake (CO) (time frame: 90 min). 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 19 Oct 2020; AzTrials last refreshed its copy on 6 Nov 2026.