Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving

March 13, 2024 updated by: Columbia University
The purpose of this study is to determine whether Cue Extinction Training will reduce relapse rates in cigarette smokers using the patch to quit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nicotine dependence is an important public health problem that contributes to significant morbidity and mortality in our society. Treatment efforts are hampered by high relapse rates, despite the development of somewhat effective treatment modalities, such as Nicotine Replacement Treatment (NRT). NRT, e.g. the nicotine patch, is successful in smoking cessation, compensating for nicotine withdrawal after quitting smoking.

However, relapse rates remain high even in quitters on the patch. It is thought that cravings related to smoking cues contribute to relapse in smokers on the patch who try to quit. Rational treatment approaches for nicotine dependence therefore include strategies to weaken the effect of smoking cues, e.g. cue extinction training (CET). During CET smokers are repeatedly exposed to smoking cues, in the absence of nicotine administration, and smokers report lessening of cue-induced craving (extinction). It is thought that the extinction of smoking cues will result in less control of the smoking cue over smoking behavior and lower relapse rates.

The investigators hypothesize that smoking quit rates on the patch will be higher after CET. To address our hypothesis the investigators first want to develop a proof of concept procedure that demonstrates that repeated cue exposure in the laboratory results in the lessening or 'extinction' of cue-induced craving. In addition, the investigators are interested in the contribution of nicotine withdrawal to cue-induced craving. To this end, the investigators propose to include a control group without nicotine replacement (i.e. placebo patch) that will also undergo the repeated cue exposure procedure.

This study will assess the effect of CET on subsequent craving triggered by smoking cues in cigarette-smoking volunteers. After overnight abstinence, participants will come into the lab, receive a patch (nicotine or placebo) and undergo the CET procedure and perform computer tests and fill out questionnaires.

The main goal of this project is to study the relationship between nicotine replacement, cue-extinction training and subsequent cue-induced craving. Showing the effectiveness of cue-extinction training in the proposed laboratory model will support the application of the cue-extinction procedure to improve relapse rates of nicotine replacement therapies in future clinical trials.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute - Substance Use Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • A DSM-IV Diagnosis of nicotine dependence with physiological dependence. Smoke at least 15 cigarettes daily for two years.
  • Not interested in treatment.
  • Medically healthy on the basis of physical examination and medical history, vital signs, EKG and laboratory tests, with a negative pregnancy test for females.
  • Able to perform study procedures.
  • Males or females between the ages of 21-60 years.
  • Female participants agree to use an effective method of birth control during the course of the study.

Exclusion Criteria:

  • A DSM-IV diagnosis of abuse or dependence on alcohol or drugs other than nicotine.
  • Current Axis I diagnosis or current treatment with psychotropic medications (within last 3 months).
  • Lifetime history of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders.
  • Seeking treatment for nicotine dependence.
  • Participants on parole or probation.
  • History of significant recent violent behavior.
  • Unstable medical condition, Blood Pressure > 150/90, Pregnancy.
  • History of allergic reaction to nicotine patch.
  • Participants with significant cardiac history (i.e. angina pectoris, bypass surgery, or coronary artery disease.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicotine Replacement Therapy, 7mg dose
Behavioral: Cue Extinction Training
Repeated exposure to cigarette cues while receiving Nicotine Replacement Therapy.
Drug: Nicotine Replacement Therapy
Study doctor applies a nicotine patch to the participant's shoulder blade. The patch dose is blinded by placement of a Bandaid over the patch itself.
Other Names:
  • Nicoderm CQ
Behavioral: Cue Extinction Therapy
Participant is repeatedly exposed to cigarette cues without being allowed to partake in nicotine use.
Behavioral: Progressive Muscle Relaxation
Participant relaxes muscles in her body, lead through the process using guided imagery and breathing techniques.
Experimental: Nicotine Replacement Therapy, 21mg dose
Behavioral: Cue Extinction Training
Repeated exposure to cigarette cues while receiving Nicotine Replacement Therapy.
Drug: Nicotine Replacement Therapy
Study doctor applies a nicotine patch to the participant's shoulder blade. The patch dose is blinded by placement of a Bandaid over the patch itself.
Other Names:
  • Nicoderm CQ
Behavioral: Cue Extinction Therapy
Participant is repeatedly exposed to cigarette cues without being allowed to partake in nicotine use.
Behavioral: Progressive Muscle Relaxation
Participant relaxes muscles in her body, lead through the process using guided imagery and breathing techniques.
Placebo Comparator: Nicotine Replacement Therapy, Placebo
Behavioral: Cue Extinction Training
Repeated exposure to cigarette cues while receiving Nicotine Replacement Therapy.
Behavioral: Cue Extinction Therapy
Participant is repeatedly exposed to cigarette cues without being allowed to partake in nicotine use.
Behavioral: Progressive Muscle Relaxation
Participant relaxes muscles in her body, lead through the process using guided imagery and breathing techniques.
Experimental: Nicotine Replacement Therapy, 42mg dose
Behavioral: Cue Extinction Training
Repeated exposure to cigarette cues while receiving Nicotine Replacement Therapy.
Drug: Nicotine Replacement Therapy
Study doctor applies a nicotine patch to the participant's shoulder blade. The patch dose is blinded by placement of a Bandaid over the patch itself.
Other Names:
  • Nicoderm CQ
Behavioral: Cue Extinction Therapy
Participant is repeatedly exposed to cigarette cues without being allowed to partake in nicotine use.
Behavioral: Progressive Muscle Relaxation
Participant relaxes muscles in her body, lead through the process using guided imagery and breathing techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Galvanic Skin Response
Time Frame: 3 days, over the course of 4-5 weeks total.
Measurements of Galvanic Skin Response (GSR) are taken while participant is exposed to the cue. The amount of change in GSR is used to determine CET's impact on cigarette craving.
3 days, over the course of 4-5 weeks total.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: S. Rob Vorel, MD, PhD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

April 5, 2011

First Posted (Estimated)

April 6, 2011

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6001
  • K23DA025735 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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