Phase 4
Completed N=20
Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.
Source: ClinicalTrials.gov NCT00991081 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcomePrimary: Continuous Abstinence at 12 Weeks Post Target Quit Date — 3; 2 participants
Summary
The major purpose of this exploratory developmental study will be to develop a patient-centered and feasible protocol for communicating genetic data as it relates to drug efficacy for smoking cessation inpatients receiving medication that is matched to individual genotypes associated with increased efficacy for bupropion or nicotine replacement therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous Abstinence at 12 Weeks Post Target Quit Date |
3; 2 | — |
| SECONDARY Morisky Adherence Scale |
2.7; 1.8 | — |
| SECONDARY Trust Scale |
19.3; 18.8 | — |
| SECONDARY Communication Scale |
19.4; 19.4 | — |
| SECONDARY Satisfaction Scale |
19.4; 19.5 | — |
| SECONDARY Treatment Interest Scale |
9.0; 9.6 | — |
| SECONDARY Depression |
6.1; 4.1 | — |
| SECONDARY Fatalism |
1.1; 0.4 | — |
| SECONDARY Intention to Quit |
18.3; 19.5 | — |
| SECONDARY Motivation |
6.2; 6.4 | — |
| SECONDARY Perceived Control |
14.0; 13.4 | — |
| SECONDARY Risk Perception |
15.3; 16.1 | — |
| SECONDARY Self-Efficacy |
16.2; 15.6 | — |
| SECONDARY Threat Minimization |
8.9; 7.3 | — |
Eligibility Criteria
Inclusion and exclusion criteria are the same for participants in the formative interviews (Study A) and the feasibility RCT (Study B) except that Study A will include African American and European American smokers and Study B will include European American smokers.
Inclusion criteria
- Adults (aged 18 or older)
- Currently smoke at least 10 cigarettes per day
- Motivated to quit smoking (>=5 on a 10-point Likert scale)
- Have a telephone
- Read and speak English.
Exclusion criteria
- Any medical contraindications for transdermal nicotine replacement therapy (NRT) or sustained-release bupropion hydrochloride (bupropion) use based on the package labels (e.g., for bupropion, risk of seizure)
- DSM-IV Axis I diagnosis (other than nicotine dependence)
- Subjects who meet criteria for current major depression, or who demonstrate evidence of suicidal ideation at screening will be referred to treatment for depression and will be excluded from the study
- Must agree not to seek other treatment for smoking cessation during the study.
Data sourced from ClinicalTrials.gov (NCT00991081). 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.