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Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cue Extinction Training
Nicotine Replacement Therapy
Cue Extinction Therapy
Progressive Muscle Relaxation
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • New York State Psychiatric Institute - Substance Use Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Nicotine Replacement Therapy, 7mg dose

Nicotine Replacement Therapy, 21mg dose

Nicotine Replacement Therapy, Placebo

Nicotine Replacement Therapy, 42mg dose

Arm Description

Outcomes

Primary Outcome Measures

Galvanic Skin Response
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.

Secondary Outcome Measures

Full Information

First Posted
October 14, 2010
Last Updated
October 1, 2020
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01329614
Brief Title
Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving
Official Title
Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether Cue Extinction Training will reduce relapse rates in cigarette smokers using the patch to quit.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nicotine Replacement Therapy, 7mg dose
Arm Type
Experimental
Arm Title
Nicotine Replacement Therapy, 21mg dose
Arm Type
Experimental
Arm Title
Nicotine Replacement Therapy, Placebo
Arm Type
Placebo Comparator
Arm Title
Nicotine Replacement Therapy, 42mg dose
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cue Extinction Training
Intervention Description
Repeated exposure to cigarette cues while receiving Nicotine Replacement Therapy.
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement Therapy
Other Intervention Name(s)
Nicoderm CQ
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cue Extinction Therapy
Intervention Description
Participant is repeatedly exposed to cigarette cues without being allowed to partake in nicotine use.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Muscle Relaxation
Intervention Description
Participant relaxes muscles in her body, lead through the process using guided imagery and breathing techniques.
Primary Outcome Measure Information:
Title
Galvanic Skin Response
Description
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.
Time Frame
3 days, over the course of 4-5 weeks total.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S. Rob Vorel, M.D., Ph.D.
Organizational Affiliation
New York State Psychiatric Institute, Substance Use Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute - Substance Use Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving

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