Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01329614
First received: October 14, 2010
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Tobacco Use Disorder
Behavioral: Cue Extinction Training
Drug: Nicotine Replacement Therapy
Behavioral: Cue Extinction Therapy
Behavioral: Progressive Muscle Relaxation
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Galvanic Skin Response [ Time Frame: 3 days, over the course of 4-5 weeks total. ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: October 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329614

Locations
United States, New York
New York State Psychiatric Institute - Substance Use Research Center
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: S. Rob Vorel, M.D., Ph.D. New York State Psychiatric Institute, Substance Use Research Center
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01329614     History of Changes
Other Study ID Numbers: 6001
Study First Received: October 14, 2010
Last Updated: July 24, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014