---
title: Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.
nct_id: NCT00991081
overall_status: COMPLETED
phase: PHASE4
sponsor: Stanford University
study_type: INTERVENTIONAL
primary_condition: Smoking
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00991081.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00991081"
ct_last_update_post_date: 2012-09-19
last_seen_at: "2026-05-12T07:16:27.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Behaviorally Enhanced Counseling on Nicotine Dependence (BEACON) Trial.

**Official Title:** Exploratory/Developmental Study of Pharmacogenetic Smoking Cessation Therapy.

**NCT ID:** [NCT00991081](https://clinicaltrials.gov/study/NCT00991081)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 36
- **Lead Sponsor:** Stanford University
- **Collaborators:** SRI International, Johns Hopkins University, University of Bristol, National Institute on Drug Abuse (NIDA)
- **Conditions:** Smoking
- **Start Date:** 2009-07
- **Completion Date:** 2011-03
- **CT.gov Last Update:** 2012-09-19

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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
- **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

## Interventions

- **Counseling** (BEHAVIORAL) — 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
- **Self-help guide** (BEHAVIORAL) — A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail
- **Pharmacotherapy** (DRUG) — 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, verbal** (BEHAVIORAL) — During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment
- **Genetic feedback, printed** (BEHAVIORAL) — 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.

## Primary Outcomes

- **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.

## 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)_

## Locations (3)

- SRI International, Menlo Park, California, United States
- Stanford University School of Medicine, Stanford, California, United States
- Group Health Research Institute, Seattle, Washington, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sri international|menlo park|california|united states` — added _(2026-05-12)_
- `locations.stanford university school of medicine|stanford|california|united states` — added _(2026-05-12)_
- `locations.group health research institute|seattle|washington|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00991081.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00991081*  
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