CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 36 enrolled
Drug / intervention
Pharmacotherapy +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00991081
NCT00991081Phase 4Completed
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Exploratory/Developmental Study of Pharmacogenetic Smoking Cessation Therapy.

Stanford University·interventional·Posted Oct 7, 2009·Updated Sep 19, 2012

In Brief

A Phase 4 clinical trial evaluating Counseling, Self-help guide, and 3 other interventions for Smoking. Completed, enrolled 36 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking
CountriesUnited States
CollaboratorsSRI International, Johns Hopkins University, University of Bristol, National Institute on Drug Abuse (NIDA)

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 7, 2009
Enrollment StartJul 1, 2009
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.7 years ago

Interventions

Counselingbehavioral

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 guidebehavioral

A printed self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail

Pharmacotherapydrug

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, verbalbehavioral

During the first counseling call, GF participants were informed of their genotype and provided with the rationale for their pharmacotherapy assignment

Genetic feedback, printedbehavioral

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.