Effects of Nicotine Replacement and Repeated Cue Exposure on Cigarette Craving
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): Cue Extinction Training; Nicotine Replacement Therapy; Cue Extinction Therapy; Progressive Muscle Relaxation
Intervention type(s): Behavioral; Drug; Behavioral; Behavioral
Intervention description(s): Repeated exposure to cigarette cues while receiving 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.; Participant is repeatedly exposed to cigarette cues without being allowed to partake in nicotine use.; Participant relaxes muscles in her body, lead through the process using guided imagery and breathing techniques.
Other intervention name(s): Nicoderm CQ
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment