Extinction Based Treatment for Nicotine Dependence
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test two quit smoking therapies and to study brain function
      while each therapy is being used. You will be randomly assigned (like flipping a coin) to one
      of the two groups. The first therapy is Extinction-Based therapy (EBT). If you are in this
      group, you will switch to smoking denicotinized cigarettes while wearing a 21 mg/d nicotine
      patch for one month prior to your quit date. The second therapy is a standard Nicotine
      Replacement therapy (NRT). If you are in this group, you will smoke your usual brand of
      cigarettes up to the quit date. Following the quit date, both groups will undergo standard
      nicotine replacement therapy (21 mg/d for 6 weeks; 14 mg/d for 2 weeks, 7 mg/d for 2 weeks).

      In addition to the above, we will recruit a sample of former smokers who are now regular
      users of e-cigarettes. This group [ECIG] will undergo the same screening and baseline
      assessments as the EBT and NRT groups up to the completion of fMRI1.
    

Detailed description: 
      If you agree to be in this study, you will be asked to sign the consent form prior to any
      tests or procedures. You will be asked to come to the laboratory for a screening session. The
      screening session will take approximately 1.5 hours to complete, including all
      questionnaires, physical and sample collection. Pregnant or nursing mothers will not be
      allowed to participate in this study. If you test positive for illegal drug use, you will not
      be allowed to participate in this study. Depending on the results of the screening procedures
      you may not be eligible for the study. If you do not have any medical conditions that would
      make your participation risky, and you feel comfortable participating in the study, you will
      be given instructions regarding the rest of the study sessions and be asked to return.

      Smoker participants who complete the screening visit (described above) and meet all study
      requirements will then complete 8 lab visits, 1 fMRI training session, 3 fMRI sessions, and 2
      follow-up visits. ECIG participants who complete the screening visit and meet all study
      requirements will complete 1 fMRI training session and 1 fMRI session.

      First you will be randomly assigned (like drawing out of a hat) to a study group, either the
      EBT or NRT group. In the extinction-based therapy (EBT) group, participants will switch to
      smoking denicotinized cigarettes while wearing a 21 mg/d nicotine patch for one month prior
      to their quit date; meanwhile, smokers assigned to the nicotine replacement therapy (NRT)
      group will smoke their usual brand of cigarettes up to the quit date. Following the quit
      date, both groups will undergo standard nicotine replacement therapy (21 mg/d for 6 weeks; 14
      mg/d for 2 weeks, 7 mg/d for 2 weeks).

      Eight lab visits (V1 - V8) will be conducted during the 16 weeks following enrollment in the
      study. These visits will be largely identical, except that instructions and reminders to you
      about upcoming events will vary from session to session. At each lab visit the following will
      be collected: vitals (heart rate, blood pressure and weight); breath CO (Carbon Monoxide) and
      saliva samples for testing smoking and nicotine levels; and measures of smoking withdrawal
      and mood. You will be given daily diaries to record your smoking behavior and study
      medication. You will be given instructions on how and when to use all study materials. Advice
      on quitting and minimal support will be provided as requested at these visits. Each lab visit
      will require 20-30 minutes of your time.

      Directly following V1 you will undergo a training session, during which you will be
      familiarized with all aspects of the fMRI sessions including tasks and equipment. You will be
      situated in a scanner simulator, which simulates the sounds and equipment used in the fMRI
      scanner.

      One task will require you to view pictures of people smoking and people doing everyday
      activities. After the task, you will be quizzed on the pictures you saw. During another task,
      you will be presented with a stream of gray, yellow, or blue colored circles and instructed
      to press a button every time you see a "Go" trial while inhibiting a response (not pressing
      the button) when you are presented with a "No-Go" trial. The training session will require 1
      hour of participant time.

      fMRI Sessions:

      You will be asked to complete three fMRI scanning sessions: a baseline scan (fMRI-1); a scan
      4 weeks after you start treatment (fMRI-2); and a final scan 24 hours after your quit date
      (fMRI-3). The first 20 minutes of each scanning session will follow the same protocol as a
      lab visit. Following this, for fMRI-1 and fMRI-2 you will be asked to smoke a cigarette
      (usual brand or denicotinized depending on session and group). No cigarette will be smoked
      prior to fMRI-3. After smoking your cigarette you will sit in a quiet room and read magazines
      for 30 minutes. Following the 30 min rest period, you will be escorted to the fMRI suite at
      Duke University Medical Center. Once inside, you will complete questionnaires regarding your
      current mood and withdrawal symptoms. We will take a CO and saliva sample at the beginning of
      each scan. If you are wearing a nicotine replacement patch, you will remove it before
      entering the scanner. Then you will be given specific instructions regarding data collection
      procedures and be placed in the scanner. During the scanning you will perform each of the
      tasks, and lie still while we take pictures of your brain. After being removed from the
      scanner, you will complete post-session withdrawal and mood questionnaires and replace the
      removed patch. End-of-session instructions will then be provided:

        -  At the end of fMRI-1, ECIG participants will be released from the study. Smoker
           participants will be randomly assigned to either the EBT or NRT group, and given
           supplies and information regarding upcoming sessions.

        -  At the end of fMRI-2, you will be reminded of the quit date which you agreed upon
           previously, and you will be given supplies and information regarding quitting.

        -  At the end of fMRI-3, you will be given reminders about upcoming sessions.

      You will be instructed not to consume any alcohol on the night before each scanning session.

      We will ask for a breath and saliva sample before each session to make sure you have followed
      all directions about wearing the patch and smoking your usual brand or the denicotinized
      cigarettes as instructed. If the test indicates that you have not followed directions, you
      will be sent home (this will be considered a missed visit) and the visit will be
      re-scheduled. If this occurs on 2 consecutive visits, your further participation in the study
      will be terminated.

      Follow-Up Sessions:

      After completing all study visits, you will be asked to return for two follow-up sessions,
      one at 6 months and one at 12 months from visit 1. At these follow-up sessions we will ask
      for breath and saliva samples, and have you fill out paperwork regarding your mood and
      current smoking status.
    

Intervention name(s): Nicotine Patches, Denicotinized Cigarettes
Intervention type(s): Drug
Intervention description(s): Both groups will receive standard Nicotine Replacement Therapy after the quit date. The Extinction Based group will receive Nicotine patches and denicotinized cigarettes before their quit date
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking; nicotine patches; extinction based treatment