SmokingPhase 4NCT00991081
Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.
A Phase 4 study testing Counseling, Self-help guide and Pharmacotherapy in people with Smoking, run by Stanford University at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Counseling, Self-help guide and Pharmacotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2009to Mar 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
SRI International
Menlo Park, California, 94025
Group Health Research Institute
Seattle, Washington, 98101
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking
- Being tested
- Counseling, Self-help guide, Pharmacotherapy, Genetic feedback, verbal, Genetic feedback, printed
- Keywords
- pharmacogenetics, genetic counseling, genetic feedback, nicotine replacement, bupropion, smoking cessation, primary care, telehealth, motivational interviewing
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
Also called Motivational interviewing, Motivational enhancement
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 guideBehavioural
Also called Support Materials, Clearing the Air
A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail
PharmacotherapyDrug
Also called NRT, Nicotine Replacement Therapy, The Patch, Bupropion
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
Genetic feedback, verbalBehavioural
Also called Pharmacogenetics, Pharmacogenetic counseling
During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment
Genetic feedback, printedBehavioural
Also called Pharmacogenetics, Pharmacogenetic Feedback
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | * 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 Receives: Behavioral: Counseling; Behavioral: Self-help guide; Drug: Pharmacotherapy |
| Genetic feedback plus standard treatment | Experimental | 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 Receives: Behavioral: Counseling; Behavioral: Self-help guide; Drug: Pharmacotherapy; Behavioral: Genetic feedback, verbal; Behavioral: Genetic feedback, printed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after Target Quit Date
Secondary outcomes (13)
Morisky Adherence Scale
Category: Treatment Acceptability Measures: Treatment Compliance Range: 0-8 Direction: Higher values represent higher compliance
Measured: 12 weeks after Target Quit Date
Trust Scale
Category: Treatment Acceptability Measures: Trust in the clinician Range: 5-30 Direction: Higher values represent higher trust
Measured: Within 1 week of first clinical call
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
Measured: Within 1 week of first clinical call
Satisfaction Scale
Category: Treatment Acceptability Measures: Overall satisfaction with the clinician Range: 4-20 Direction: Higher values represent higher satisfaction
Measured: Within 1 week of first clinical call
Treatment Interest Scale
Category: Treatment Acceptability Measures: Interest in participating in recommended treatment plan Range: 1-10 Direction: Higher values represent higher treatment interest
Measured: Within 1 week of first clinical call
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
Measured: Within 1 week of first clinical call
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
Measured: 12 weeks after Target Quit Date
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
Measured: Within 1 week of first clinical call
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
Measured: Within 1 week of first clinical call
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
Measured: Within 1 week of first clinical call
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
Measured: Within 1 week of first clinical call
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
Measured: Within 1 week of first clinical call
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
Measured: Within 1 week of first clinical call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- SRI International, Johns Hopkins University, University of Bristol, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Sean P David, MD SM DPhil, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991081
- Sponsor's protocol ID
- SU-09152009-3940
- Other IDs
- 5R21DA027331-03, Protocol # 16513
- Status last verified
- Aug 2012
- First submitted
- 6 Oct 2009
- Last updated
- 19 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22949583
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory/Developmental Study of Pharmacogenetic Smoking Cessation Therapy.
- ClinicalTrials.gov ID
- NCT00991081
- Acronym / sponsor ID
- SU-09152009-3940
- Conditions
- Smoking
- Keywords
- pharmacogenetics, genetic counseling, genetic feedback, nicotine replacement, bupropion, smoking cessation, primary care, telehealth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- SRI International, Johns Hopkins University, University of Bristol, National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Oct 2009 (estimated)
- Results
- Posted 19 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Behavioral: Counseling, Behavioral: Self-help guide, Drug: Pharmacotherapy* 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 |
| Genetic feedback plus standard treatment | Experimental | Behavioral: Counseling, Behavioral: Self-help guide, Drug: Pharmacotherapy, Behavioral: Genetic feedback, verbal, Behavioral: Genetic feedback, printedIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingAlso: Motivational interviewing, Motivational enhancementThree 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 | Behavioural | Genetic feedback plus standard treatment, Standard treatment |
| Self-help guideAlso: Support Materials, Clearing the AirA printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail | Behavioural | Genetic feedback plus standard treatment, Standard treatment |
| PharmacotherapyAlso: NRT, Nicotine Replacement Therapy, The Patch, Bupropion8-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 | Drug | Genetic feedback plus standard treatment, Standard treatment |
| Genetic feedback, verbalAlso: Pharmacogenetics, Pharmacogenetic counselingDuring the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment | Behavioural | Genetic feedback plus standard treatment |
| Genetic feedback, printedAlso: Pharmacogenetics, Pharmacogenetic FeedbackAfter 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. | Behavioural | Genetic feedback plus standard treatment |
Primary outcome
Continuous Abstinence at 12 Weeks Post Target Quit Date
Time frame: 12 weeks after 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.
13 secondary outcomes
Morisky Adherence Scale
Time frame: 12 weeks after Target Quit Date
Trust Scale
Time frame: Within 1 week of first clinical call
Communication Scale
Time frame: Within 1 week of first clinical call
Satisfaction Scale
Time frame: Within 1 week of first clinical call
Treatment Interest Scale
Time frame: Within 1 week of first clinical call
Depression
Time frame: Within 1 week of first clinical call
Fatalism
Time frame: 12 weeks after Target Quit Date
Intention to Quit
Time frame: Within 1 week of first clinical call
Motivation
Time frame: Within 1 week of first clinical call
Perceived Control
Time frame: Within 1 week of first clinical call
Risk Perception
Time frame: Within 1 week of first clinical call
Self-Efficacy
Time frame: Within 1 week of first clinical call
Threat Minimization
Time frame: Within 1 week of first clinical call
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22949583McClure 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean P David, MD SM DPhil principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Counseling, Self-help guide and Pharmacotherapy in people with Smoking, run by Stanford University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Abstinence at 12 Weeks Post Target Quit Date (time frame: 12 weeks after Target Quit Date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00991081, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2012.