Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23DA025736 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized trial will evaluate whether varenicline directly observed therapy provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence.
There is a marked prevalence of tobacco use and tobacco-related disease among methadone maintenance patients. Varenicline's demonstrated efficacy may not be generalizable to methadone maintained smokers because of poor adherence, which is highly prevalent among drug users. Adherence to smoking cessation medication is strongly associated with cessation, and is one of the few factors shown to increase cessation among methadone maintained smokers, but strategies to promote smoking cessation medication adherence have not been evaluated in methadone patients. Based on the Information, Motivation, and Behavior model, the investigators plan a directly observed therapy (DOT)-based intervention targeting behavioral skills necessary for optimal adherence. Because methadone clinic-based DOT interventions have been shown to improve medication adherence and clinical outcomes in HIV and TB, the investigators plan to determine in a randomized trial whether DOT varenicline provided at a methadone clinic is more efficacious than self-administered varenicline for promoting smoking cessation and enhancing adherence. The investigators will also evaluate moderating effects of drug and alcohol use and psychiatric symptoms on DOT effects. The investigators hypothesize subjects in the mDOT arm will have greater 7 day point prevalence abstinence at 12 weeks, reduction in cigarettes/day, time to first daily cigarette, ≥ 24 hour quit attempts, and 7 day point prevalence abstinence at 24 weeks compared to subjects receiving self administered varenicline. The investigators also hypothesize that adherence in the mDOT arm will be higher than in the TAU arm. Lastly the investigators hypothesize that ongoing illicit drug use and psychiatric symptoms will moderate the effect of mDOT on adherence.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varenicline treatment as usual (TAU) | Experimental | Subjects in the TAU arm will self administer varenicline for 12 weeks. |
|
| Varenicline directly observed therapy | Experimental | Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Varenicline Adherence as Measured by Pill Count | Pill count adherence, measured as pills taken divided by pills dispensed, analyzed as a continuous measure | Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 12 Weeks | Number of participants achieving self reported, seven day point prevalence abstinence, biochemically verified with expired carbon monoxide (CO) < 8 p.p.m., missing = smoking | Week 12 of treatment |
| Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 24 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shadi Nahvi, M.D., M.S. | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37142273 | Derived | Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8. | |
| 32857445 | Derived | Nahvi S, Adams TR, Ning Y, Zhang C, Arnsten JH. Effect of varenicline directly observed therapy versus varenicline self-administered therapy on varenicline adherence and smoking cessation in methadone-maintained smokers: a randomized controlled trial. Addiction. 2021 Apr;116(4):902-913. doi: 10.1111/add.15240. Epub 2020 Oct 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline Treatment as Usual (TAU) | Subjects in the TAU arm will self administer varenicline for 12 weeks. Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks. |
| FG001 | Varenicline Directly Observed Therapy | Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends. Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline Treatment as Usual (TAU) | Subjects in the TAU arm will self administer varenicline for 12 weeks. Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks. |
| BG001 | Varenicline Directly Observed Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Varenicline Adherence as Measured by Pill Count | Pill count adherence, measured as pills taken divided by pills dispensed, analyzed as a continuous measure | Comparison of varenicline TAU and DOT groups | Posted | Mean | 95% Confidence Interval | percentage pills taken/pills dispensed | Weeks 0-1, 1-2, 2-3, 4-6, 7-9, 10-12 |
|
12 week intervention period, and 12 week post intervention follow up
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Varenicline Treatment as Usual (TAU) | Subjects in the TAU arm will self administer varenicline for 12 weeks. Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incident major depressive episode | Psychiatric disorders | Systematic Assessment | Assessed using the Mini-International Neuropsychiatric Interview 6.0.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Change in taste | General disorders | Systematic Assessment | Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shadi Nahvi, MD, MS | Albert Einstein College of Medicine | 718 920 5379 | snahvi@montefiore.org |
Not provided
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D055118 | Medication Adherence |
| D012907 | Smoking |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Number of participants achieving self reported, seven day point prevalence abstinence, biochemically verified with expired carbon monoxide (CO) < 8 p.p.m. |
| 24 weeks |
| 24928218 | Derived | Nahvi S, Segal KS, Litwin AH, Arnsten JH. Rationale and design of a randomized controlled trial of varenicline directly observed therapy delivered in methadone clinics. Addict Sci Clin Pract. 2014 Jun 13;9(1):9. doi: 10.1186/1940-0640-9-9. |
Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends. Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Cigarettes smoked per day | Median | Inter-Quartile Range | cigarettes smoked per day |
|
| Expired carbon monoxide | A measure of the amount of carbon monoxide on a person's breath, which is checked using a Smokerlyzer monitor (Bedfont Scientific). | Median | Inter-Quartile Range | parts per million |
|
| Fagerstrom Test of Nicotine Dependence score | In scoring the Fagerstrom Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. | Median | Inter-Quartile Range | units on a scale |
|
| Ladder of change score | The Ladder is a continuous measure of motivation to change smoking where a score of 1 indicates low readiness to quit smoking and a score of 10 indicates high readiness to quit smoking. | Median | Inter-Quartile Range | units on a scale |
|
| Quit importance | Quit importance measures importance of quitting smoking for participants on a scale from 1 to 10 where 1 is not important and 10 is highly important | Median | Inter-Quartile Range | units on a scale |
|
| Quit confidence | Quit confidence measures confidence in quitting smoking for participants on a scale from 1 to 10 where 1 is not confident at all and 10 is highly confident | Median | Inter-Quartile Range | units on a scale |
|
| Any past quit attempts | Number | participants |
|
| Preferred brand of cigarettes menthol | Count of Participants | Participants |
|
| Number of participants with unstable housing | Living in a shelter, temporary housing, hotel/motel, or on the street | Number | participants |
|
| Number of participants currently employed | Count of Participants | Participants |
|
| Number of participants married or living with a partner | Count of Participants | Participants |
|
| Lifetime major depressive episode | Assessed using the Mini-International Neuropsychiatric Interview 6.0.0. The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a short structured diagnostic interview for assessing DSM-IV and ICD-10 psychiatric disorders. | Count of Participants | Participants |
|
| Lifetime psychotic disorder | Assessed using the Mini-International Neuropsychiatric Interview 6.0.0. The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a short structured diagnostic interview for assessing DSM-IV and ICD-10 psychiatric disorders. | Count of Participants | Participants |
|
| Lifetime suicide attempt | Assessed using the Columbia Suicide Severity Scale, a structured interview which assesses suicidal ideation, plans, intent, and behavior | Count of Participants | Participants |
|
| Severe global psychiatric symptoms | Assessed using the Brief Symptom Inventory Global Severity Index, a 53-item self report scale, with scores dichotomized at a T score ≥ 63 | Count of Participants | Participants |
|
| Currently receiving psychiatric treatment | Count of Participants | Participants |
|
| Participants with COPD/Asthma | Count of Participants | Participants |
|
| Participants with HIV/AIDS | Count of Participants | Participants |
|
| Median duration methadone maintenance | Median | Inter-Quartile Range | years |
|
| Median methadone dose | Median | Inter-Quartile Range | mg |
|
|
|
| Secondary | Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 12 Weeks | Number of participants achieving self reported, seven day point prevalence abstinence, biochemically verified with expired carbon monoxide (CO) < 8 p.p.m., missing = smoking | intent to treat | Posted | Count of Participants | Participants | Week 12 of treatment |
|
|
|
| Secondary | Tobacco Abstinence Biochemically Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. at 24 Weeks | Number of participants achieving self reported, seven day point prevalence abstinence, biochemically verified with expired carbon monoxide (CO) < 8 p.p.m. | Missing = smoking | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| 0 |
| 50 |
| 2 |
| 50 |
| 50 |
| 50 |
| EG001 | Varenicline Directly Observed Therapy | Subjects in the directly observed therapy (DOT) arm will receive varenicline directly administered by methadone clinic nurses 4-6 times per week at the same time as they receive methadone, as well as individually packaged take-home doses for self administration on evenings/weekends. Varenicline: Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks. | 0 | 50 | 3 | 50 | 50 | 50 |
|
| Incident psychotic disorder | Psychiatric disorders | Systematic Assessment | Assessed using the Mini-International Neuropsychiatric Interview 6.0.0 |
|
| Suicidal ideation | Psychiatric disorders | Systematic Assessment | Wishes to be dead, or thoughts of killing self, assessed using the Columbia Suicide Severity Scale |
|
|
| Dry mouth | General disorders | Systematic Assessment | Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment |
|
| Change in appetite | General disorders | Systematic Assessment | Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment |
|
| Nausea | General disorders | Systematic Assessment | Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment |
|
| Vomiting | General disorders | Systematic Assessment | Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment |
|
| Gas | General disorders | Systematic Assessment | Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment |
|
| Constipation | General disorders | Systematic Assessment | Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment |
|
| Change in concentration | General disorders | Systematic Assessment | Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment |
|
| Headache | General disorders | Systematic Assessment | Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment |
|
| Fatigue | General disorders | Systematic Assessment | Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment |
|
| Insomnia | General disorders | Systematic Assessment | Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment |
|
| Dizziness | General disorders | Systematic Assessment | Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment |
|
| Irritability | General disorders | Systematic Assessment | Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment |
|
| Vivid/more frequent dreams | General disorders | Systematic Assessment | Assessed through structured questionnaire, assessing specific symptoms reported in varenicline clinical trials, and open-ended assessment |
|
Not provided
Not provided
Not provided
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D011810 | Quinoxalines |