Tobacco DependencePhase 2NCT03507127
Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1
A Phase 2 study testing Varenicline in people with Tobacco Dependence, run by Brown University at 1 site in United States.
Trial summary
Schizophrenia is associated with high rates of cigarette smoking and associated morbidity and mortality. In this study, smokers with schizophrenia will complete a baseline session and then randomized to varenicline (VAR) or placebo (PLA). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 30 Jun 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women
- Ages 18-65
- Have schizophrenia or schizoaffective disorder
- Would like to quit smoking within the next 6 months
- Have smoked at least 10 cigarettes per day in the past year
- Have breath CO level > 10 ppm
- Able to speak, read and comprehend English well enough to complete study procedures
Who cannot join
- Pregnant, breast-feeding, or unwilling to use medically-approved contraception
- Currently using varenicline, bupropion or nicotine replacement therapy for smoking cessation
- Medical disease that would preclude participation
- Unstable psychiatric conditions
- Body mass index (BMI) < 15 or > 38 kg/m2
- Past-month suicidal intention, with or without a specific plan
- Positive urine drug screen or breath alcohol level > 0.01% at screening
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
Schizophrenia is associated with high rates of cigarette smoking and associated morbidity and mortality. In this study, smokers with schizophrenia will complete a baseline session and then randomized to varenicline (VAR) or placebo (PLA). After 1 week on medication, participants will complete a cigarette rating task session. Participants will then undergo a 72-hr abstinence period in which they will come to the laboratory twice per day and receive high-value cash reinforcement contingent upon meeting a strict breath CO abstinence criterion. At each visit, they will rate withdrawal symptoms, mood and craving. At the end of the abstinence period, they will repeat the cigarette rating task. Participants will return to the lab to provide a CO sample 24 hours later, and will text the lab with videos of their CO samples for one week. Date and time of smoking relapse will be measured from these samples.
- Conditions
- Tobacco Dependence
- Being tested
- Varenicline, Placebo
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.
PlaceboDrug
Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
| Study group | Role | What they receive |
|---|---|---|
| Varenicline | Active comparator | Not described Receives: Drug: Varenicline |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire on Smoking Urges - Brief Form
Average of all items, rated from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate higher levels of smoking urge or craving.
Measured: 72 hrs abstinence
Minnesota Nicotine Withdrawal Scale - Negative Affect Scale
Average of responses to the anger, depression, anxiety and difficulty concentrating items, which are rated from 0 (not present) to 4 (severe).
Measured: 72 hrs abstinence
Secondary outcomes (3)
Modified Cigarette Evaluation Questionnaire - Satisfaction Scale
Average of the satisfaction, taste and enjoyment items, which are rated from 1 (not at all) to 7 (extremely)
Measured: 72 hrs abstinence
Modified Cigarette Evaluation Questionnaire - Reward Scale
Average of the calm, feel more awake, less irritable, help to concentrate and reduce hunger items, which are rated from 1 (not at all) to 7 (extremely)
Measured: 72 hrs abstinence
Latency to Smoking Relapse
hours until relapse during a smoking abstinence period, verified with breath carbon monoxide (CO) levels
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start1 May 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Why it stopped: Low rate of enrollment
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 DependenceStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Tidey, Brown University
- Investigators
- Jennifer Tidey, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507127
- Sponsor's protocol ID
- R21DA041114
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2018
- Last updated
- 17 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1
- ClinicalTrials.gov ID
- NCT03507127
- Acronym / sponsor ID
- R21DA041114
- Conditions
- Tobacco Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low rate of enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Posted 17 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Schizophrenia is associated with high rates of cigarette smoking and associated morbidity and mortality. In this study, smokers with schizophrenia will complete a baseline session and then randomized to varenicline (VAR) or placebo (PLA). After 1 week on medication, participants will complete a cigarette rating task session. Participants will then undergo a 72-hr abstinence period in which they will come to the laboratory twice per day and receive high-value cash reinforcement contingent upon meeting a strict breath CO abstinence criterion. At each visit, they will rate withdrawal symptoms, mood and craving. At the end of the abstinence period, they will repeat the cigarette rating task. Participants will return to the lab to provide a CO sample 24 hours later, and will text the lab with videos of their CO samples for one week. Date and time of smoking relapse will be measured from these samples.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Active comparator | Drug: Varenicline |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women
- Ages 18-65
- Have schizophrenia or schizoaffective disorder
- Would like to quit smoking within the next 6 months
- Have smoked at least 10 cigarettes per day in the past year
Key exclusion criteria (7 listed)
- Pregnant, breast-feeding, or unwilling to use medically-approved contraception
- Currently using varenicline, bupropion or nicotine replacement therapy for smoking cessation
- Medical disease that would preclude participation
- Unstable psychiatric conditions
- Body mass index (BMI) < 15 or > 38 kg/m2
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 |
|---|---|---|
| VareniclineStandard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period. | Drug | Varenicline |
| PlaceboDosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period. | Drug | Placebo |
Primary outcome
Questionnaire on Smoking Urges - Brief Form
Time frame: 72 hrs abstinence
Average of all items, rated from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate higher levels of smoking urge or craving.
Minnesota Nicotine Withdrawal Scale - Negative Affect Scale
Time frame: 72 hrs abstinence
Average of responses to the anger, depression, anxiety and difficulty concentrating items, which are rated from 0 (not present) to 4 (severe).
3 secondary outcomes
Modified Cigarette Evaluation Questionnaire - Satisfaction Scale
Time frame: 72 hrs abstinence
Modified Cigarette Evaluation Questionnaire - Reward Scale
Time frame: 72 hrs abstinence
Latency to Smoking Relapse
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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, PhD 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 Varenicline in people with Tobacco Dependence, 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 17 May 2022. 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 17 May 2022). 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?
Questionnaire on Smoking Urges - Brief Form (time frame: 72 hrs abstinence). The study lists 2 primary outcomes in all. 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 17 May 2022.