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Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving

Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01329614
Enrollment
40
Registered
2011-04-06
Start date
2009-10-31
Completion date
2013-07-31
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Disorder

Keywords

Tobacco, Nicotine, Cigarette

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.

Interventions

BEHAVIORALCue Extinction Training

Repeated exposure to cigarette cues while receiving Nicotine Replacement Therapy.

DRUGNicotine 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.

BEHAVIORALCue Extinction Therapy

Participant is repeatedly exposed to cigarette cues without being allowed to partake in nicotine use.

BEHAVIORALProgressive Muscle Relaxation

Participant relaxes muscles in her body, lead through the process using guided imagery and breathing techniques.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Galvanic Skin Response3 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026