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Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco withdrawal symptoms and increases long term cessation rates when combined with transdermal nicotine and a behavioral cessation programs. The study is a placebo-controlled, randomized, parallel group trial in which smokers aged 18-70 will be subject to the combination of oral and patch treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Transdermal nicotine plus nortriptyline |
|
| 2 | Active Comparator | Transdermal nicotine plus placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nortriptyline | Drug | Dose titrated to 75 mg daily as tolerated combined with transdermal nicotine 21 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Validated smoking cessation | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allan V. Prochazka, MD MSc | VA Eastern Colorado Health Care System, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Eastern Colorado Health Care System, Denver | Denver | Colorado | 80220 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15534159 | Result | Prochazka AV, Kick S, Steinbrunn C, Miyoshi T, Fryer GE. A randomized trial of nortriptyline combined with transdermal nicotine for smoking cessation. Arch Intern Med. 2004 Nov 8;164(20):2229-33. doi: 10.1001/archinte.164.20.2229. | |
| 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 |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D009661 | Nortriptyline |
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| transdermal nicotine | Drug | Transdermal nicotine 21 mg, titrated down plus placebo |
|
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D013812 | Therapeutics |