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Pharmacogenetics, Emotional Reactivity and Smoking

NCT00507728 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 646

Last updated 2021-05-06

Study results available
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Summary

The goals of this placebo-controlled randomized clinical trial were to evaluate the differences in emotional reactivity (peak startle response to affective stimuli) during a cessation attempt among smokers treated with bupropion, varenicline, or placebo, and to determine if these differences were moderated by genotype.

Conditions

  • Tobacco Use Disorder
  • Smoking Cessation

Interventions

DRUG

Bupropion

Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)

DRUG

Varenicline

Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)

DRUG

Placebo

Placebo by mouth for 12 weeks.

BEHAVIORAL

Smoking Cessation Counseling

Counseling over 8 months and telephone support calls.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Paul Cinciripini, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-08
Primary Completion
2019-12-18
Completion
2019-12-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00507728 on ClinicalTrials.gov