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| ID | Type | Description | Link |
|---|---|---|---|
| 2U54DA036151-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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To examine if switching from menthol to non-menthol cigarettes will change the dose-effect curves for positive subjective effects and alleviation of smoking urges as a function of nicotine delivery rate in smokers.
A placebo-controlled study that will recruit male and female menthol nicotine dependent smokers. Following screening and evaluation as described above, eligible participants will be enrolled in the study which will last about 4 weeks. Eligible, participants will be randomized to menthol or non-menthol smoking condition for 2 weeks (Phase 1) and then will be switched to the alternative condition for another 2 weeks (Phase 2). The smoking condition will be open label. Participants will be provided with free cigarettes in Phases 1 and 2. For the menthol condition, participants will be provided their usual brand of menthol cigarettes and for the non-menthol condition, they will be provided a matched-brand non-menthol cigarette (e.g., Newport Non-Menthol Gold 100s for those who smoke Newport Menthol Gold 100s). In week 2 of each Phase, participants will have a test session. Each session will include 3 infusions in the same order: nicotine (1 mg per 70 kg body weight) delivered over 5 minutes, saline and nicotine (1 mg/ 70 kg) delivered over 2.5 minutes. Once the participants complete the test session, participants will be crossed-over to the alternative treatment. The period between the 2 Phases will not be longer than one week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| menthol cigarettes | Active Comparator | Will smoke only menthol cigarettes for two weeks |
|
| non menthol cigarettess | Active Comparator | Will only smoke non menthol cigarettes for two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine | Drug | session will include 3 infusions in the same order: nicotine (1 mg per 70 kg body weight) delivered over 5 minutes, saline and nicotine (1 mg/ 70 kg) delivered over 2.5 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Effect Questionnaire - Stimulatory Effects | Drug Effects Questionnaire was used to assess participants. The DEQ is consist of 10 items measured on a 1 to 100 visual analog scale, ranging from "not at all" to "extremely.". These ratings were then averaged to create three domain scores reflecting 1) stimulatory effects (average of "feel stimulated", "feel drug effects" and "feel high"), 2) pleasurable effects (average of "like", "feel good " and "want more"), and 3) aversive effects (average of "feel anxious", "feel down" and "feel bad"). Head rush was also assessed. Scores on the subscales range from 0 - 100 where 0 is the measure of least impactful 'effect'. | Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutes |
| Drug Effect Questionnaire - Pleasure Effect | Drug Effects Questionnaire was used to assess participants. The DEQ is consist of 10 items measured on a 1 to 100 visual analog scale, ranging from "not at all" to "extremely.". These ratings were then averaged to create three domain scores reflecting: 1) stimulatory effects (average of "feel stimulated", "feel drug effects" and "feel high"), 2) pleasurable effects (average of "like", "feel good " and "want more"), and 3) aversive effects (average of "feel anxious", "feel down" and "feel bad"). Head rush was also assessed. Scores on the subscales range from 0 - 100 where 0 is the measure of least impactful 'effect'. | Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutes |
| Drug Effect Questionnaire - Aversive Effect | Drug Effects Questionnaire was used to assess participants. The DEQ is consist of 10 items measured on a 1 to 100 visual analog scale, ranging from "not at all" to "extremely.". These ratings were then averaged to create three domain scores reflecting: 1) stimulatory effects (average of "feel stimulated", "feel drug effects" and "feel high"), 2) pleasurable effects (average of "like", "feel good " and "want more"), and 3) aversive effects (average of "feel anxious", "feel down" and "feel bad"). Head rush was also assessed. Scores on the subscales range from 0 - 100 where 0 is the measure of least impactful 'effect'. |
| Measure | Description | Time Frame |
|---|---|---|
| SAFTEE | The SAFTEE is a technique for the systematic assessment of side effects in clinical trials developed by National Institute of Mental Health. It is a questionnaire that rates the current severity of a wide range of somatic, behavioral and affective symptoms in general and specific inquiry formats. It is designed to report adverse health events, regardless of whether or not they are suspected to be drug related, in order to reduce the under-reporting of unanticipated events compared with "known or expected" events. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet Sofuoglu, M.D.,Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Veterans Affairs Hospital | West Haven | Connecticut | 06516 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Menthol FIRST, Non-Menthol SECOND | Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases. |
| FG001 | Non-Menthol FIRST, Menthol SECOND | Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants randomized to one of two crossover arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Participants | All participants in the study prior to randomization to crossover order. Eligible participants were individuals who reported smoking at least 5 cigarettes a day for the past year and had urine cotinine levels exceeding 100 ng/mL, an indicator of daily smoking. Participants were not interested in quitting smoking and were free of major medical and psychiatric disorders, including substance use disorders (except tobacco use), as confirmed by medical and psychiatric assessment. |
| 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 | Drug Effect Questionnaire - Stimulatory Effects | Drug Effects Questionnaire was used to assess participants. The DEQ is consist of 10 items measured on a 1 to 100 visual analog scale, ranging from "not at all" to "extremely.". These ratings were then averaged to create three domain scores reflecting 1) stimulatory effects (average of "feel stimulated", "feel drug effects" and "feel high"), 2) pleasurable effects (average of "like", "feel good " and "want more"), and 3) aversive effects (average of "feel anxious", "feel down" and "feel bad"). Head rush was also assessed. Scores on the subscales range from 0 - 100 where 0 is the measure of least impactful 'effect'. | Participants assessed an any or both points in the crossover design. | Posted | Mean | Standard Deviation | units on a scale | Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutes |
|
4 weeks total (2 sessions of 2 week smoking periods) - each with 2 3 hour sessions.
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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 | Menthol | Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mehmet Sofuoglu, MD, PhD: Professor of Psychiatry; Director of VA New England Mental Illness Researc | Yale School of Medicine | (203) 937-4809 | mehmet.sofuoglu@yale.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 | Jun 16, 2023 | Jun 28, 2024 | 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 |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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subjects will be unblinded to smoking menthol or non menthol for two weeks before each test session. Each session will include 3 infusions in the same order: nicotine (1 mg per 70 kg body weight) delivered over 5 minutes, saline and nicotine (1 mg/ 70 kg) delivered over 2.5 minutes. Once the participants complete the test session, participants will be crossed-over to the alternative treatment.
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The cigarette condition is unblinded but the nicotine infusion is blinded to participant
|
| Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutes |
| Drug Effect Questionnaire - Head Rush | Drug Effects Questionnaire was used to assess participants. The DEQ is consist of 10 items measured on a 1 to 100 visual analog scale, ranging from "not at all" to "extremely.". These ratings were then averaged to create three domain scores reflecting: 1) stimulatory effects (average of "feel stimulated", "feel drug effects" and "feel high"), 2) pleasurable effects (average of "like", "feel good " and "want more"), and 3) aversive effects (average of "feel anxious", "feel down" and "feel bad"). Head rush was also assessed. Scores on all subscales, including Head Rush scale, range from 0 - 100 where lower scores indicate less head rush. | Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutes |
| up to one year |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Average number of cigarettes consumed daily | Mean | Standard Deviation | cigarettes per day |
|
| Fagerstrom Test for Nicotine Dependence (FTND) | The total score ranges from 0 to 10. Higher scores indicate a greater dependence on nicotine: 0-2 points: Very low dependence, 3-4 points: Low dependence, 5 points: Medium dependence, 6-7 points: High dependence, 8-10 points: Very high dependence. | Mean | Standard Deviation | units on a scale |
|
Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases.
| OG001 | Non-Menthol | Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases. |
|
|
|
| Primary | Drug Effect Questionnaire - Pleasure Effect | Drug Effects Questionnaire was used to assess participants. The DEQ is consist of 10 items measured on a 1 to 100 visual analog scale, ranging from "not at all" to "extremely.". These ratings were then averaged to create three domain scores reflecting: 1) stimulatory effects (average of "feel stimulated", "feel drug effects" and "feel high"), 2) pleasurable effects (average of "like", "feel good " and "want more"), and 3) aversive effects (average of "feel anxious", "feel down" and "feel bad"). Head rush was also assessed. Scores on the subscales range from 0 - 100 where 0 is the measure of least impactful 'effect'. | Participants assessed an any or both points in the crossover design. | Posted | Mean | Standard Deviation | units on a scale | Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutes |
|
|
|
|
| Secondary | SAFTEE | The SAFTEE is a technique for the systematic assessment of side effects in clinical trials developed by National Institute of Mental Health. It is a questionnaire that rates the current severity of a wide range of somatic, behavioral and affective symptoms in general and specific inquiry formats. It is designed to report adverse health events, regardless of whether or not they are suspected to be drug related, in order to reduce the under-reporting of unanticipated events compared with "known or expected" events. | these data were not collected | Posted | up to one year |
|
|
| Primary | Drug Effect Questionnaire - Aversive Effect | Drug Effects Questionnaire was used to assess participants. The DEQ is consist of 10 items measured on a 1 to 100 visual analog scale, ranging from "not at all" to "extremely.". These ratings were then averaged to create three domain scores reflecting: 1) stimulatory effects (average of "feel stimulated", "feel drug effects" and "feel high"), 2) pleasurable effects (average of "like", "feel good " and "want more"), and 3) aversive effects (average of "feel anxious", "feel down" and "feel bad"). Head rush was also assessed. Scores on the subscales range from 0 - 100 where 0 is the measure of least impactful 'effect'. | Participants assessed an any or both points in the crossover design. | Posted | Mean | Standard Deviation | units on a scale | Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutes |
|
|
|
|
| Primary | Drug Effect Questionnaire - Head Rush | Drug Effects Questionnaire was used to assess participants. The DEQ is consist of 10 items measured on a 1 to 100 visual analog scale, ranging from "not at all" to "extremely.". These ratings were then averaged to create three domain scores reflecting: 1) stimulatory effects (average of "feel stimulated", "feel drug effects" and "feel high"), 2) pleasurable effects (average of "like", "feel good " and "want more"), and 3) aversive effects (average of "feel anxious", "feel down" and "feel bad"). Head rush was also assessed. Scores on all subscales, including Head Rush scale, range from 0 - 100 where lower scores indicate less head rush. | Participants assessed an any or both points in the crossover design. | Posted | Mean | Standard Deviation | units on a scale | Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutes |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Non-Menthol | Participants were randomized to either menthol or non-menthol cigarette smoking condition for 2 weeks (Phase 1) and then switched to the other condition for another 2 weeks (Phase 2), in a crossover design. Participants received free cigarettes throughout both phases. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| 10 minutes |
|
| 10 minutes |
|
| 10 minutes |
|