Clinical trial NCT00991081
Conditions: Smoking
Keywords: pharmacogenetics genetic counseling genetic feedback nicotine replacement bupropion smoking cessation primary care telehealth motivational interviewing
Sponsor: Stanford University
Start date: 2009-07-01; Completion date: 2011-03-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: * 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 arm 2: 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: intervention 1: Counseling intervention 2: Self-help guide intervention 3: Pharmacotherapy intervention 4: Genetic feedback, verbal intervention 5: Genetic feedback, printed
Intervention descriptions: intervention 1: 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 intervention 2: A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail intervention 3: 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 intervention 4: During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment intervention 5: 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.

Protocol documents: