Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.

Smoking Clinical Trial

Official title:

Exploratory/Developmental Study of Pharmacogenetic Smoking Cessation Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991081
• Other study ID #: SU-09152009-3940
• Secondary ID: 5R21DA027331-03P
• Status: Completed
• Phase: Phase 4
• First received: October 6, 2009
• Last updated: August 21, 2012
• Start date: July 2009
• Est. completion date: March 2011

Study information

• Verified date: August 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Counseling
Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling One week prior to the target quit date (TQD) Two weeks post-TQD Four weeks post-TQD
• Self-help guide
A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail

Drug:
• Pharmacotherapy
8-week course of genetically-tailored pharmacotherapy Participants with the A1 allele (TT/CT) were assigned to receive NRT (the Patch) Participants with the A2 allele (CC) were assigned to receive bupropion

Behavioral:
• Genetic feedback, verbal
During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment
• Genetic feedback, printed
After the first counseling call, GF participants were mailed a Personal Treatment Profile, which echoed each participant's ANNK1 genotype, the implications of this for smoking cessation treatment outcome, and which medication was chosen for them based on their genotype.

Locations

Country	Name	City	State
United States	SRI International	Menlo Park	California
United States	Group Health Research Institute	Seattle	Washington
United States	Stanford University School of Medicine	Stanford	California

Sponsors (5)

Lead Sponsor	Collaborator
Stanford University	Johns Hopkins University, National Institute on Drug Abuse (NIDA), SRI International, University of Bristol

Country where clinical trial is conducted

United States, 

References & Publications (1)

McClure JB, Swan GE, St John J, Fauver R, Javitz HS, Bergen AW, Nishita D, Niaura R, Munafò 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous Abstinence at 12 Weeks Post Target Quit Date	Participants reporting continuous tobacco-use abstinence 12 weeks after their Target Quit Date, whose salivary cotinine levels confirmed their abstinence, were counted as "abstinent." All others were recorded as not abstinent.	12 weeks after Target Quit Date	No
Secondary	Morisky Adherence Scale	Category: Treatment Acceptability Measures: Treatment Compliance Range: 0-8 Direction: Higher values represent higher compliance	12 weeks after Target Quit Date	No
Secondary	Trust Scale	Category: Treatment Acceptability Measures: Trust in the clinician Range: 5-30 Direction: Higher values represent higher trust	Within 1 week of first clinical call	No
Secondary	Communication Scale	Category: Treatment Acceptability Measures: Quality of verbal interaction and responsiveness during counseling sessions Range: 4-20 Direction: Higher values represent greater interaction and responsiveness	Within 1 week of first clinical call	No
Secondary	Satisfaction Scale	Category: Treatment Acceptability Measures: Overall satisfaction with the clinician Range: 4-20 Direction: Higher values represent higher satisfaction	Within 1 week of first clinical call	No
Secondary	Treatment Interest Scale	Category: Treatment Acceptability Measures: Interest in participating in recommended treatment plan Range: 1-10 Direction: Higher values represent higher treatment interest	Within 1 week of first clinical call	No
Secondary	Depression	Category: Psychological Outcome Instrument: Center for Epidemiologic Studies Depression Scale (CES-D) Measures: Interest in participating in recommended treatment plan Range: 0-60 Direction: Higher values represent increased symptoms of depression	Within 1 week of first clinical call	No
Secondary	Fatalism	Category: Psychological Outcome Instrument: Powe Fatalism Inventory, 10-item, revised Measures: belief in inevitability of smoking status Range: 0-10 Direction: Higher values represent increased fatalism beliefs	12 weeks after Target Quit Date	No
Secondary	Intention to Quit	Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Intention, confidence, and expectation of quitting smoking Range: 3-21 Direction: Higher values represent increased intention to quit	Within 1 week of first clinical call	No
Secondary	Motivation	Category: Psychological Outcome Instrument: Single item, Likert scale from 1 to 7 Measures: Desire to quit smoking Range: 1-7 Direction: Higher values represent increased motivation to quit	Within 1 week of first clinical call	No
Secondary	Perceived Control	Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Control over ability to quit smoking in the next month Range: 3-21 Direction: Higher values represent increased sense of control	Within 1 week of first clinical call	No
Secondary	Risk Perception	Category: Psychological Outcome Instrument: 4-item inventory, Likert scale from 1 to 5 Measures: Perceived personal health risks from smoking Range: 4-20 Direction: Higher values represent increased perception of risk	Within 1 week of first clinical call	No
Secondary	Self-Efficacy	Category: Psychological Outcome Instrument: 3-item inventory, Likert scale from 1 to 7 Measures: Perceived ability to quit smoking in the next month Range: 3-21 Direction: Higher values represent increased self-efficacy	Within 1 week of first clinical call	No
Secondary	Threat Minimization	Category: Psychological Outcome Instrument: 2-item inventory, Likert scale from 1 to 7 Measures: Perceived presence of factors that would reduce personal smoking risks Range: 2-14 Direction: Higher values represent increased risk minimization	Within 1 week of first clinical call	No