Clinical trial NCT00991081: Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.
Official title: Exploratory/Developmental Study of Pharmacogenetic Smoking Cessation Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking
Keywords: pharmacogenetics
genetic counseling
genetic feedback
nicotine replacement
bupropion
smoking cessation
primary care
telehealth
motivational interviewing
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: SRI International
name: Johns Hopkins University
name: University of Bristol
name: National Institute on Drug Abuse (NIDA)
First posted: 2009-10-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Therefore, our specific aims are to:

Aim 1: Conduct formative research to develop and refine a clinical protocol for a multi-component smoking cessation intervention, grounded in the extended parallel process model, consisting of pharmacogenetic treatment (smoking cessation drug matched to each individual smoker's genotype) and genetic feedback (delivery of patient-centered, personalized genotype information and its predictive value for smoking cessation treatment efficacy): We will adapt, pilot-test, and refine a theoretically-grounded PGx smoking cessation intervention using formative interviews of 20 African-American and European-ancestry smokers.

Aim 2: Conduct a mixed-methods feasibility trial randomizing treatment-seeking smokers to pharmacogenetic (PGx) treatment combined with genetic feedback (GF) vs. PGx treatment without GF for smoking cessation to examine the feasibility of the newly developed protocol in a primary care setting and characterize its psychological and behavioral impact: Smokers (N = 100) will be randomized to GF vs. no GF and all will receive motivational interviewing (standard care/SC) and PGx treatment. We will assess the impact of GF on time to relapse, medication adherence, and a comprehensive assessment battery of process and cognitive, psychological, and behavioral outcomes. Finally, we will synthesize quantitative and qualitative data to revise protocols, generate hypothesizes, and estimate effect sizes for a follow-up R01 submission.

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.

Primary outcomes:
measure: Continuous Abstinence at 12 Weeks Post Target Quit Date
timeFrame: 12 weeks after Target Quit Date
Secondary outcomes:
measure: Morisky Adherence Scale
timeFrame: 12 weeks after Target Quit Date
measure: Trust Scale
timeFrame: Within 1 week of first clinical call
measure: Communication Scale
timeFrame: Within 1 week of first clinical call
measure: Satisfaction Scale
timeFrame: Within 1 week of first clinical call
measure: Treatment Interest Scale
timeFrame: Within 1 week of first clinical call
measure: Depression
timeFrame: Within 1 week of first clinical call
measure: Fatalism
timeFrame: 12 weeks after Target Quit Date
measure: Intention to Quit
timeFrame: Within 1 week of first clinical call
measure: Motivation
timeFrame: Within 1 week of first clinical call
measure: Perceived Control
timeFrame: Within 1 week of first clinical call
measure: Risk Perception
timeFrame: Within 1 week of first clinical call
measure: Self-Efficacy
timeFrame: Within 1 week of first clinical call
measure: Threat Minimization
timeFrame: Within 1 week of first clinical call
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: SRI International
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Stanford University
name: Sean P David, MD SM DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: McClure JB, Swan GE, St John J, Fauver R, Javitz HS, Bergen AW, Nishita D, Niaura R, Munafo MR, David SP. Pharmacogenetic smoking cessation intervention in a health care setting: a pilot feasibility study. Nicotine Tob Res. 2013 Feb;15(2):518-26. doi: 10.1093/ntr/nts173. Epub 2012 Sep 4.