Phase 2
Completed N=60
A Pilot Study Evaluating Nicotine Lozenges and Self Help
Smokeless Tobacco Use
Source: ClinicalTrials.gov NCT00888459 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2010
Primary outcomePrimary: Number of Participants With Tobacco Abstinence — 14; 11 participants — p=.432
Summary
The investigators are hypothesizing that by offering both self-help materials and mailed nicotine lozenges we will be able to help increase tobacco abstinence rates among ST users, as well as decrease tobacco withdrawal.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Tobacco Abstinence |
14; 11 | .432 |
Eligibility Criteria
Inclusion Criteria
- male;
- ≥18 years of age;
- report ST as their primary tobacco of use;
- have used ST daily for the past 6 months;
- indicate that they want to quit;
- have been provided with, understand, and have signed the informed consent.
Exclusion Criteria
- previously enrolled in a study involving the use of the nicotine lozenge;
- currently using or have completed using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;
- currently enrolled in another research study;
- 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;
- have phenylketonuria (PKU) [nicotine lozenges contain aspartame which is metabolized to phenylalanine and not processed in individuals with PKU];
- have another member of their household already participating in this study;
- have other medical or psychiatric conditions that would exclude the participant;
- have a score of ≥ 15 on the Patient Health Questionnaire (PHQ-9) on the phone call pre-screen.
Data sourced from ClinicalTrials.gov (NCT00888459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.