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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL090313 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.
HIV-infected smokers are at increased risk for life-threatening diseases, such as pneumonia. To date, very little is known about the tobacco consumption characteristics of this at-risk population of smokers, but it has been well documented that they are at high risk for smoking-related co-morbidities. In addition, few effective cessation strategies have been described in HIV-infected populations. A specialized smoking cessation that combines recommendations from an existing scientifically-valid clinical guideline with Motivational Interviewing a new pharmacotherapeutic agent, may be an effective mechanism to apply to this vulnerable population of smokers. This initial, efficacy investigation has the potential to guide future treatment and research pertaining to tobacco cessation, respiratory illness and HIV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Control - Non-smoking | Other | Healthy Control arm with 51 subjects who are HIV negative and do not smoke |
|
| Healthy Control - Smoker | Other | Healthy Control arm, includes 50 subjects who are HIV negative and are smokers. |
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| HIV Smoking Cessation Arm | Active Comparator | Includes up to 365 subjects who are HIV positive and initiate smoking cessation |
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| Motivational Intervention | Experimental | Includes up to 100 subjects who are HIV positive, do not wish to quit smoking but are willing to undergo one-on-one Motivational Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline tartrate | Drug | 1 mMg tablet form; daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Safety of Varenicline in PLWH Who Smoke | To determine the safety and tolerability of varenicline compared to nicotine replacement | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke | To compare biochemically confirmed tobacco abstinence rates among smokers living with HIV treated with nicotine replacement vs varenicline | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip T. Diaz, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Replacement Plus Motivational Interviewing | PLWH who smoke 12 week intervention with telephone counseling plus: Nicotine Replacement Therapy: Nicotine gum (4 mg ad lib) and nicotine patch (21 mg) |
| FG001 | Varenicline Plus Motivational Interviewing | PLWH who smoke 12 week intervention with telephone counseling plus: Varenicline tartrate: 0.5 mg daily days 1-3; 0.5 mg twice daily days 4-7; then 1.0 mg twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Replacement Plus Motivational Interviewing | PLWH who smoke 12 week intervention with telephone counseling plus: Nicotine Replacement Therapy: Nicotine gum (4 mg ad lib) and nicotine patch (21 mg) |
| BG001 | Varenicline Plus Motivational Interviewing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | To Determine the Safety of Varenicline in PLWH Who Smoke | To determine the safety and tolerability of varenicline compared to nicotine replacement | Three-month abstinence rates among participants who received NRT were compared with those who received varenicline. Although some participants stopped taking the pharmacotherapy, or switched from varenicline to NRT, for the analysis , they were kept in their initial group. Because treatment assignment was not random, inverse probability of treatment weighting (IPTW) adjustment was performed. A propensity score was estimated as the probability of receiving varenicline, given measured covariates | Posted | Count of Participants | Participants | 3 months |
|
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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 | Nicotine Replacement Plus Motivational Interviewing | PLWH who smoke 12 week intervention with telephone counseling plus: Nicotine Replacement Therapy: Nicotine gum (4 mg ad lib) and nicotine patch (21 mg) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin rash |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Philip Diaz | Ohio State University | 6142934925 | diaz.3@osu.edu |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| D000095488 | Nicotine Replacement Therapy |
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Nicotine Replacement Therapy | Drug | Nicotine gum and nicotine patch |
|
| Biological Control | Other | No treatment intervention only information and procedures. |
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| Motivational Interview | Behavioral | 60 minute one-on-one Interview |
|
PLWH who smoke 12 week intervention with telephone counseling plus: Varenicline tartrate: 0.5 mg daily days 1-3; 0.5 mg twice daily days 4-7; then 1.0 mg twice daily |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Varenicline Plus Motivational Interviewing | PLWH who smoke 12 week intervention with telephone counseling plus: Varenicline tartrate: 0.5 mg daily days 1-3; 0.5 mg twice daily days 4-7; then 1.0 mg twice daily |
|
|
| Secondary | To Determine the Efficacy of Varenicline for Smoking Cessation Among PLWH Who Smoke | To compare biochemically confirmed tobacco abstinence rates among smokers living with HIV treated with nicotine replacement vs varenicline | Abstinence rates among participants who received NRT were compared with those who received varenicline. Although some participants stopped taking the pharmacotherapy, or switched from varenicline to NRT, for the analysis , they were kept in their initial group. Because treatment assignment was not random, inverse probability of treatment weighting (IPTW) adjustment was performed. A propensity score was estimated as the probability of receiving varenicline, given measured covariates | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 110 |
| 0 |
| 110 |
| 56 |
| 110 |
| EG001 | Varenicline Plus Motivational Interviewing | PLWH who smoke 12 week intervention with telephone counseling plus: Varenicline tartrate: 0.5 mg daily days 1-3; 0.5 mg twice daily days 4-7; then 1.0 mg twice daily | 0 | 118 | 1 | 118 | 94 | 118 |
| Skin redness | Skin and subcutaneous tissue disorders |
|
| Nausea | Gastrointestinal disorders |
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| Insomnia | Psychiatric disorders |
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| Vivid dreams | Psychiatric disorders |
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| agitation | Psychiatric disorders |
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| headache | Nervous system disorders |
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| Constipation | Gastrointestinal disorders |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D011810 | Quinoxalines |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| 12 month biochemically confirmed abstinence rate |
|