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| ID | Type | Description | Link |
|---|---|---|---|
| R01-15732-1 |
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The purpose of this study is to evaluate the extended pharmacological and psychological treatment for chronic cigarette smokers.
The work adapts interventions that have been successful in the general populations, and tailors them to chronic smokers, who may have numerous previous smoking treatment failures. If successful it will: (1) make available a treatment intervention that produces hight long term abstinence rates; (2) provide information on variables that predicts success and failure in this population of smokers; (3) examine the cost-effectiveness of more intensive, longer term treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief Treatment | Active Comparator | Participants will start with a 21 mg nicotine patch, tapering to 14 mg patch and finally tapering to 7 mg patch. The nicotine patch will be administered on Week 3 of the program. Participants will meet with medical staff during Weeks 1, 2, 5, and 11. Five group counseling sessions must be attended by the participants. Assessments will be conducted on Weeks 12, 24, 36, 52, 64, and 104. |
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| Extended Bupropion/Low Contact | Active Comparator | Participants will receive the Brief Treatment followed by ongoing Bupropion treatment through Week 52. Participants will meet with medical staff once a month. |
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| Extended Placebo/Low Contact | Placebo Comparator | Participants will receive the Brief Treatment followed by placebo medication (sugar-pill) through Week 52 and meet with medical staff once a month. |
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| Extended Bupropion/High Contact | Active Comparator | Participants will receive Brief Treatment followed by ongoing bupropion treatment through Week 52. Participants will attending counseling session 20-40 minutes in duration and will be scheduled at weeks 12, 14, 16, 18, 20, 24, 28, 32, 36, 44, and 52. The contents of these sessions will introduce additional information focusing on motivation, social support, mood management, weight gain, and dependence/withdrawal. Subjects will be contact by phone between counseling sessions (at Weeks 13, 15, 18, 22, 26, 30, 34, 36, 40, 48) for a brief check-in. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupropion and NRT | Drug | All participants receive standard 12 week treatment of NRT, bupropion and five group counseling sessions. At week 11, subjects are randomly assigned to one of five treatment groups (1) Bupropion/Low Contact; (2) Placebo/Low Contact; (3) Bupropion/Relapse Prevention; (4) Placebo/Relapse Prevention; (5) No Further Treatment. Data is collected at Week 0, and at weeks 12, 24, 52, 64, and 104. |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Behavior | 2 |
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Subjects (N=400) will be men and women (50%) over the age of 18 who smoke at least 10 cigarettes per day and answers yes to the question "Do you smoke within 30 minutes of arising?"
Inclusion Criteria:
-Subjects are age 18 and over, currently smoking 10 or more cigarettes per day, and report a smoking history of at least 5 years in response to the question "How long have you been a regular smoker?"
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon M Hall, Ph.D. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University California, San Francisco | San Francisco | California | 94143-0984 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37230961 | Derived | Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6. |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D004358 | Drug Therapy |
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| Extended Placebo/High Contact | Placebo Comparator | Participants receive the Brief Treatment followed by a placebo medication through Week 52 and meet with medical staff once per month. Participants will attending counseling session 20-40 minutes in duration and will be scheduled at weeks 12, 14, 16, 18, 20, 24, 28, 32, 36, 44, and 52. The contents of these sessions will introduce additional information focusing on motivation, social support, mood management, weight gain, and dependence/withdrawal. Subjects will be contact by phone between counseling sessions (at Weeks 13, 15, 18, 22, 26, 30, 34, 36, 40, 48) for a brief check-in. |
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| D001519 | Behavior |
| D013812 |
| Therapeutics |