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Low rate of enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varenicline | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 72 hrs abstinence |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 72 hrs abstinence |
| Modified Cigarette Evaluation Questionnaire - Reward Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Psychiatric Rating Scale | Sum of all items rated from 1 (not present) to 7 (extremely severe) | 72 hrs abstinence |
Inclusion Criteria:
Exclusion Criteria:
gender is based on self-report
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Tidey, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University, 121 South Main Street | Providence | Rhode Island | 02912 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline | Varenicline: 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. |
| FG001 | Placebo | Placebo: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline | Varenicline: 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 72 hrs abstinence |
|
19 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Varenicline | Varenicline: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| voluntary psychiatric hospitalization | Psychiatric disorders | Non-systematic Assessment | Participant used alcohol and drugs leading to auditory hallucinations and voluntary psychiatric hospitalization. Determined to be unrelated to study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment | One participant experienced mild nausea and one instance of vomiting while in the study. The study physician reviewed these events and determined that they were expected, possibly related, and did not involve risk. |
Early termination leading to small number of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Tidey | Brown University | 4018636418 | jennifer_tidey@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2017 | Jun 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | 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. |
|
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) |
| 72 hrs abstinence |
| Latency to Smoking Relapse | hours until relapse during a smoking abstinence period, verified with breath carbon monoxide (CO) levels | 1 week |
Placebo: 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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Fagerstrom Test of Nicotine Dependence score | This scale measures nicotine dependence severity. Total score is reported, and scores can range from 0-10, with higher scores indicating more severe dependence. | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | score on a scale | 72 hrs abstinence |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | 72 hrs abstinence |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | 72 hrs abstinence |
|
|
|
| Secondary | Latency to Smoking Relapse | hours until relapse during a smoking abstinence period, verified with breath carbon monoxide (CO) levels | Posted | Mean | Standard Deviation | hours | 1 week |
|
|
|
| Other Pre-specified | Brief Psychiatric Rating Scale | Sum of all items rated from 1 (not present) to 7 (extremely severe) | Posted | Mean | Standard Deviation | score on a scale | 72 hrs abstinence |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | Placebo | Placebo: 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. | 0 | 2 | 1 | 2 | 0 | 2 |
|
|
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| D011810 | Quinoxalines |