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
  Purpose

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.


Condition Intervention Phase
Smoking
Behavioral: Counseling
Behavioral: Self-help guide
Drug: Pharmacotherapy
Behavioral: Genetic feedback, verbal
Behavioral: Genetic feedback, printed
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exploratory/Developmental Study of Pharmacogenetic Smoking Cessation Therapy.

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 36
Study Start Date: July 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991081

Locations
United States, California
SRI International
Menlo Park, California, United States, 94025
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Stanford University
SRI International
Johns Hopkins University
University of Bristol
Investigators
Principal Investigator: Sean P David, MD SM DPhil Stanford University
  More Information

Publications:
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).

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00991081     History of Changes
Other Study ID Numbers: SU-09152009-3940, 5R21DA027331-03, Protocol # 16513
Study First Received: October 6, 2009
Results First Received: June 25, 2012
Last Updated: August 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
pharmacogenetics
genetic counseling
genetic feedback
nicotine replacement
bupropion
smoking cessation
primary care
telehealth
motivational interviewing

Additional relevant MeSH terms:
Nicotine
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014