A Pilot Study Evaluating Nicotine Lozenges and Self Help
Klíčová slova
Abstraktní
Popis
Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Most smokeless tobacco users wish to quit. Assisted-self help interventions (i.e., self-help manual, a targeted video, and two support telephone phone calls) have been shown to be superior to manual-only interventions for increasing tobacco abstinence rates. These interventions lend themselves to widespread dissemination, but abstinence rates at 6 months remains low (21%). Providing nicotine replacement therapy (NRT) to ST users receiving assisted self-help interventions could improve upon these ST abstinence rates. If found to be effective, this intervention may increase the ability to disseminate effective interventions to a population of tobacco users for whom few treatment resources currently exist.
Termíny
| Poslední ověření: | 06/30/2011 |
| První předloženo: | 04/23/2009 |
| Odhadovaná registrace vložena: | 04/23/2009 |
| První zveřejnění: | 04/26/2009 |
| Poslední aktualizace byla odeslána: | 07/13/2011 |
| Poslední aktualizace zveřejněna: | 07/17/2011 |
| Datum prvních předložených výsledků: | 10/03/2010 |
| Datum prvních předložených výsledků kontroly kvality: | 10/03/2010 |
| Datum prvních zveřejněných výsledků: | 11/03/2010 |
| Aktuální datum zahájení studie: | 03/31/2008 |
| Odhadované datum dokončení primární: | 03/31/2009 |
| Odhadované datum dokončení studie: | 04/30/2009 |
Stav nebo nemoc
Intervence / léčba
Drug: active
Drug: 2
Fáze
Skupiny zbraní
| Paže | Intervence / léčba |
|---|---|
| Active Comparator: active Self-help counseling material and 4 mg nicotine lozenges | Drug: active 4 mg nicotine lozenges, ad lib, for 12 weeks. |
| Placebo Comparator: 2 self help counseling material and placebo nicotine lozenges | Drug: 2 Placebo nicotine lozenges |
Kritéria způsobilosti
| Věky způsobilé ke studiu | 18 Years Na 18 Years |
| Pohlaví způsobilá ke studiu | Male |
| Přijímá zdravé dobrovolníky | Ano |
| Kritéria | Inclusion Criteria: 1. male; 2. ≥18 years of age; 3. report ST as their primary tobacco of use; 4. have used ST daily for the past 6 months; 5. indicate that they want to quit; 6. have been provided with, understand, and have signed the informed consent. Exclusion Criteria: 1. previously enrolled in a study involving the use of the nicotine lozenge; 2. currently using or have completed using (past 30 days) any other behavioral or pharmacologic tobacco treatment program; 3. currently enrolled in another research study; 4. describe having a medical history of: a) unstable angina; b) myocardial infarction within the past 6 months; c) cardiac dysrhythmia other than medication-controlled atrial fibrillation or PSVT; or d) medically-treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic; 5. have phenylketonuria (PKU) [nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU]; 6. have another member of their household already participating in this study; 7. have other medical or psychiatric conditions that would exclude the participant; 8. have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-9) on the phone call pre-screen. |
Výsledek
Primární výsledná opatření
1. Number of Participants With Tobacco Abstinence [12 weeks]
