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Extinction Based Treatment for Nicotine Dependence

NCT00831155 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2015-04-20

No results posted yet for this study

Summary

The purpose of this study is to test two quit smoking therapies and to study brain function while each therapy is being used. You will be randomly assigned (like flipping a coin) to one of the two groups. The first therapy is Extinction-Based therapy (EBT). If you are in this group, you will switch to smoking denicotinized cigarettes while wearing a 21 mg/d nicotine patch for one month prior to your quit date. The second therapy is a standard Nicotine Replacement therapy (NRT). If you are in this group, you will smoke your usual brand of cigarettes up to the quit date. Following the quit date, both groups will undergo standard nicotine replacement therapy (21 mg/d for 6 weeks; 14 mg/d for 2 weeks, 7 mg/d for 2 weeks).

In addition to the above, we will recruit a sample of former smokers who are now regular users of e-cigarettes. This group \[ECIG\] will undergo the same screening and baseline assessments as the EBT and NRT groups up to the completion of fMRI1.

Conditions

  • Nicotine Dependence

Interventions

DRUG

Nicotine Patches, Denicotinized Cigarettes

Both groups will receive standard Nicotine Replacement Therapy after the quit date. The Extinction Based group will receive Nicotine patches and denicotinized cigarettes before their quit date

Sponsors & Collaborators

Principal Investigators

  • Francis J McClernon, Ph.D · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00831155 on ClinicalTrials.gov