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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01DA002538 | U.S. NIH Grant/Contract | View source | |
| 11633 | Other Identifier | University of California, San Francisco |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Pfizer | INDUSTRY |
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The research is based on a chronic disorder model of cigarette smoking which suggests that long-term treatment targeted to prevent relapse may be useful. Based on this model, the investigators have developed a relapse prevention treatment to intervene on five areas important in relapse prevention, including fluctuating motivation, depression, withdrawal, weight gain, and social support. This treatment protocol has produced high long-term abstinence rates when implemented in a clinical research setting. The current study will evaluate the treatment model when implemented in a medical outpatient setting.
This study will test a series of hypotheses comparing the efficacy of the relapse prevention treatment to other extended treatments. All participants will be assessed at baseline on demographics, smoking behaviors, nicotine dependence, depression, alcohol and other drug history and problems, mood disturbance, treatment support, stress, health status, and motivation for change. Participants will be randomly assigned to one of four treatment conditions. All participants will receive 12 weeks of combined pharmacological treatment (varenicline) and behavioral treatment (five individual counseling sessions). Following this brief treatment, participants will be randomly assigned to one of four treatment protocols
Each extended treatment protocol is 40 weeks in duration following the initial 12 weeks of treatment.
All participants will be assessed at weeks 12, 24, 52, 64, and 104, on smoking as well as other psychometric measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended Brief Contact | Experimental | Following standard brief treatment, participants have monthly meetings with medical staff. |
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| Extended Health Education | Experimental | Following standard treatment, participants receive monthly counseling with content based on a health education model. |
|
| Extended Relapse Prevention plus varenicline | Experimental | Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline. |
|
| Extended Relapse Prevention | Experimental | Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 | Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 parts per million (ppm)) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. | 12 weeks following treatment initiation |
| Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 | Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. | 24 weeks following treatment initiation |
| Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 | Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. | 52 weeks following treatment initiation |
| Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 | Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. | 64 weeks following treatment initiation |
| Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 | Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Combined Extended vs Brief Treatment at Week 24 | The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis. | 24 weeks following treatment initiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Humfleet, Ph. D. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | 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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Participants were stratified based on gender, age, site, and number of cigarettes smoked per day at baseline. Participants were then randomly assigned to one of four treatment conditions derived from a double blinded allocation list prepared by a statistician. Neither participant nor the therapist were unblinded to final treatment until Week 8.
Participants were recruited from University of California, San Francisco medical clinics and the general community. Participants from the general community were recruited through flyers posted at various community health care organizations and social service agencies. Advertisements were placed in local newspapers and websites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended Brief Contact | Following standard brief treatment, participants have monthly meetings with medical staff. Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Individual counseling: Five 90 minute individual counseling sessions. Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff. |
| FG001 | Extended Health Education | Following standard treatment, participants receive monthly counseling with content based on a health education model. Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Individual counseling: Five 90 minute individual counseling sessions. individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration. |
| FG002 | Extended Relapse Prevention Plus Varenicline | Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline. Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Individual counseling: Five 90 minute individual counseling sessions. individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration. |
| FG003 | Extended Relapse Prevention | Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model. Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Individual counseling: Five 90 minute individual counseling sessions. individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Phase |
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| |||||||||||||||||||||||||||
| Extended Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Extended Brief Contact | Following standard brief treatment, participants have monthly meetings with medical staff. Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Individual counseling: Five 90 minute individual counseling sessions. Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff. |
| 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 | Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 | Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 parts per million (ppm)) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. | Posted | Count of Participants | Participants | 12 weeks following treatment initiation |
|
Up to 104 weeks
Only serious adverse events were collected for this study
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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 | Extended Brief Contact | Following standard brief treatment, participants have monthly meetings with medical staff. Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Individual counseling: Five 90 minute individual counseling sessions. Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gary Humfleet, PhD | University of California, San Francisco | (415) 476-7674 | Gary.Humfleet@ucsf.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| D008503 | Medical Staff |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Initial Individual counseling | Behavioral | Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment. |
|
| Check-ins with medical staff | Behavioral | Monthly brief (10-15 minutes) meetings with medical staff. |
|
| Extended Individual Counseling - Health Model | Behavioral | Monthly counseling sessions across a nine month period with content based on a health education model. Each session is 30-45 minutes in duration. |
|
| Extended Individual Counseling - Relapse Prevention Model | Behavioral | Eleven individual counseling sessions across a nine month period with content based on a relapse prevention model. Each session is 30-45 minutes in duration. |
|
| 104 weeks following treatment initiation |
| Comparison of Combined Extended vs Brief Treatment at Week 52 | The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis. | 52 weeks following treatment initiation |
| Death |
|
| Lost to Follow-up |
|
| COMPLETED | Week 104 |
|
| NOT COMPLETED |
|
|
| BG001 | Extended Health Education | Following standard treatment, participants receive monthly counseling with content based on a health education model. Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Individual counseling: Five 90 minute individual counseling sessions. individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration. |
| BG002 | Extended Relapse Prevention Plus Varenicline | Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline. Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Individual counseling: Five 90 minute individual counseling sessions. individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration. |
| BG003 | Extended Relapse Prevention | Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model. Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Individual counseling: Five 90 minute individual counseling sessions. individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration. |
| BG004 | 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 |
|
| Region of Enrollment | Number | participants |
|
| Number of cigarettes smoked per day | Number | participants |
|
| Extended Health Education |
Following standard treatment, participants receive monthly counseling with content based on a health education model. Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Individual counseling: Five 90 minute individual counseling sessions. individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration. |
| OG002 | Extended Relapse Prevention Plus Varenicline | Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline. Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Individual counseling: Five 90 minute individual counseling sessions. individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration. |
| OG003 | Extended Relapse Prevention | Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model. Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Individual counseling: Five 90 minute individual counseling sessions. individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration. |
|
|
| Primary | Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 | Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. | Posted | Count of Participants | Participants | 24 weeks following treatment initiation |
|
|
|
| Primary | Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 | Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. | Posted | Count of Participants | Participants | 52 weeks following treatment initiation |
|
|
|
| Primary | Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 | Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. | Posted | Count of Participants | Participants | 64 weeks following treatment initiation |
|
|
|
| Primary | Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 | Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent. | Posted | Count of Participants | Participants | 104 weeks following treatment initiation |
|
|
|
| Secondary | Comparison of Combined Extended vs Brief Treatment at Week 24 | The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis. | Posted | Count of Participants | Participants | 24 weeks following treatment initiation |
|
|
|
|
| Secondary | Comparison of Combined Extended vs Brief Treatment at Week 52 | The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis. | Posted | Count of Participants | Participants | 52 weeks following treatment initiation |
|
|
|
|
| 0 |
| 55 |
| 2 |
| 55 |
| 0 |
| 0 |
| EG001 | Extended Health Education | Following standard treatment, participants receive monthly counseling with content based on a health education model. Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Individual counseling: Five 90 minute individual counseling sessions. individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration. | 0 | 54 | 1 | 54 | 0 | 0 |
| EG002 | Extended Relapse Prevention Plus Varenicline | Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline. Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Individual counseling: Five 90 minute individual counseling sessions. individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration. | 0 | 52 | 2 | 52 | 0 | 0 |
| EG003 | Extended Relapse Prevention | Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model. Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Individual counseling: Five 90 minute individual counseling sessions. individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration. | 1 | 55 | 2 | 55 | 0 | 0 |
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Sore Throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Confusion | Psychiatric disorders | Non-systematic Assessment |
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| Concentration Impariment | Nervous system disorders | Non-systematic Assessment |
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| Muscle Sprain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Insect Bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Head Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| D015438 |
| Health Behavior |
| D011810 | Quinoxalines |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |