Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.

This study has been completed.
Sponsor:
Collaborators:
SRI International
Johns Hopkins University
University of Bristol
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00991081
First received: October 6, 2009
Last updated: August 21, 2012
Last verified: August 2012

October 6, 2009
August 21, 2012
July 2009
March 2011   (final data collection date for primary outcome measure)
Continuous Abstinence at 12 Weeks Post Target Quit Date [ Time Frame: 12 weeks after Target Quit Date ] [ Designated as safety issue: No ]
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.
Time to relapse & medication adherence [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00991081 on ClinicalTrials.gov Archive Site
  • Morisky Adherence Scale [ Time Frame: 12 weeks after Target Quit Date ] [ Designated as safety issue: No ]
    Category: Treatment Acceptability Measures: Treatment Compliance Range: 0-8 Direction: Higher values represent higher compliance
  • Trust Scale [ Time Frame: Within 1 week of first clinical call ] [ Designated as safety issue: No ]
    Category: Treatment Acceptability Measures: Trust in the clinician Range: 5-30 Direction: Higher values represent higher trust
  • Communication Scale [ Time Frame: Within 1 week of first clinical call ] [ Designated as safety issue: No ]
    Category: Treatment Acceptability Measures: Quality of verbal interaction and responsiveness during counseling sessions Range: 4-20 Direction: Higher values represent greater interaction and responsiveness
  • Satisfaction Scale [ Time Frame: Within 1 week of first clinical call ] [ Designated as safety issue: No ]
    Category: Treatment Acceptability Measures: Overall satisfaction with the clinician Range: 4-20 Direction: Higher values represent higher satisfaction
  • Treatment Interest Scale [ Time Frame: Within 1 week of first clinical call ] [ Designated as safety issue: No ]
    Category: Treatment Acceptability Measures: Interest in participating in recommended treatment plan Range: 1-10 Direction: Higher values represent higher treatment interest
  • Depression [ Time Frame: Within 1 week of first clinical call ] [ Designated as safety issue: No ]
    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
  • Fatalism [ Time Frame: 12 weeks after Target Quit Date ] [ Designated as safety issue: No ]
    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
  • Intention to Quit [ Time Frame: Within 1 week of first clinical call ] [ Designated as safety issue: No ]
    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
  • Motivation [ Time Frame: Within 1 week of first clinical call ] [ Designated as safety issue: No ]
    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
  • Perceived Control [ Time Frame: Within 1 week of first clinical call ] [ Designated as safety issue: No ]
    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
  • Risk Perception [ Time Frame: Within 1 week of first clinical call ] [ Designated as safety issue: No ]
    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
  • Self-Efficacy [ Time Frame: Within 1 week of first clinical call ] [ Designated as safety issue: No ]
    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
  • Threat Minimization [ Time Frame: Within 1 week of first clinical call ] [ Designated as safety issue: No ]
    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
comprehensive assessment battery of process and cognitive, psychological, and behavioral outcomes [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.
Exploratory/Developmental Study of Pharmacogenetic Smoking Cessation Therapy.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Smoking
  • Behavioral: Counseling

    Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling

    1. One week prior to the target quit date (TQD)
    2. Two weeks post-TQD
    3. Four weeks post-TQD
    Other Names:
    • Motivational interviewing
    • Motivational enhancement
  • Behavioral: Self-help guide
    A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail
    Other Names:
    • Support Materials
    • Clearing the Air
  • 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
    Other Names:
    • NRT
    • Nicotine Replacement Therapy
    • The Patch
    • Bupropion
    • Zyban
    • Aplenzin
    • Wellbutrin
  • 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
    Other Names:
    • Pharmacogenetics
    • Pharmacogenetic counseling
  • Behavioral: 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.
    Other Names:
    • Pharmacogenetics
    • Pharmacogenetic Feedback
  • Active Comparator: Standard treatment
    • Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling.
    • A self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail
    • A standard 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
    Interventions:
    • Behavioral: Counseling
    • Behavioral: Self-help guide
    • Drug: Pharmacotherapy
  • Experimental: Genetic feedback plus standard treatment

    In addition to the standard treatment, participants in this arm received the following interventions:

    • 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
    Interventions:
    • Behavioral: Counseling
    • Behavioral: Self-help guide
    • Drug: Pharmacotherapy
    • Behavioral: Genetic feedback, verbal
    • Behavioral: Genetic feedback, printed
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. (2012, in press).

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00991081
SU-09152009-3940, 5R21DA027331-03, Protocol # 16513
Yes
Stanford University
Stanford University
  • SRI International
  • Johns Hopkins University
  • University of Bristol
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Sean P David, MD SM DPhil Stanford University
Stanford University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP