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Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue) (VLNCCue)

This study is currently recruiting participants.
Verified January 2017 by Francis McClernon, Ph.D., Duke University Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02538042
First Posted: September 2, 2015
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Francis McClernon, Ph.D., Duke University Medical Center
  Purpose
The central objective of the project is to evaluate the effect of incorporating smoking related contexts into very low nicotine content (VLNC) cigarette extinction trials on clinically relevant, smoking-related outcomes. Adult smokers interested in quitting smoking (N=80) will be interviewed and trained to take pictures where they smoke cigarettes. Following taking these pictures, participants will then be switched to smoke VLNCs while wearing a 21 mg/d nicotine patch (EXT) for three weeks. During this 3-week treatment period, half of the sample (n=40) will be randomly assigned to undergo six, 60-minute sessions of multiple context extinction (MCE+) during which they will view smoking-related environments and smoke their assigned cigarettes. The remaining 40 participants will undergo control MCE (exposure to nature environments; MCE-) and smoke their assigned cigarettes. At the end of the three weeks, participants will quit smoking and continue to wear the nicotine patch while being followed during a 10-week abstinence period. Participants will also complete a follow-up phone call 6 months after their quit day.

Condition Intervention
Cigarette Smoking Drug: Nicotine Patch Drug: SPECTRUM Nicotine Research Cigarettes (0.07 mg) Behavioral: MCE+ Behavioral: MCE-

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Strengthening Instrumental Extinction to Prevent Smoking Relapse

Resource links provided by NLM:


Further study details as provided by Francis McClernon, Ph.D., Duke University Medical Center:

Primary Outcome Measures:
  • Change in Fagerstrom Test of Nicotine Dependence Score [ Time Frame: week 1, week 6 ]
    Effects of MCE+ (vs. MCE-) on pre-quit nicotine dependence

  • Days to Relapse [ Time Frame: week 16 ]
    Effects of MCE+ (vs. MCE-) on smoking cessation outcomes. Relapse is defined as 7 consecutive days of smoking.


Secondary Outcome Measures:
  • Change from Baseline in number of usual brand cigarettes smoked (EXT Engagement) [ Time Frame: week 1, week 6 ]
    Compliance with smoking VLNCs

  • Change in number of cigarettes smoked per day (EXT Response) [ Time Frame: week 3, week 6 ]
    Decrease in smoking behavior

  • Change in craving score during MCE task (MCE Response) [ Time Frame: week 3, week 4, week 5 ]
    Craving score across MCE sessions. Scores range from 0 (no craving) to 100 (extreme craving)

  • Change in Post-quit Cue-reactivity [ Time Frame: week 1,week 6 ]
    difference in craving responses

  • Change in Heart Rate during Cue Reactivity Task [ Time Frame: week 1 (baseline), week 6 (date of post-quit test session) ]
    physiology


Estimated Enrollment: 300
Study Start Date: September 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MCE+
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Drug: Nicotine Patch
Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking <10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked <10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
Other Name: Nicoderm CQ
Drug: SPECTRUM Nicotine Research Cigarettes (0.07 mg)
For 3 weeks prior to their quit day, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Other Name: Very Low Nicotine Content Cigarettes
Behavioral: MCE+
During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes.
MCE- (Control)
Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks.
Drug: Nicotine Patch
Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking <10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked <10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
Other Name: Nicoderm CQ
Drug: SPECTRUM Nicotine Research Cigarettes (0.07 mg)
For 3 weeks prior to their quit day, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Other Name: Very Low Nicotine Content Cigarettes
Behavioral: MCE-
During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • generally healthy (i.e. ambulatory, not currently sick)
  • interest in quitting smoking
  • smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for > 1 year
  • an expired carbon monoxide concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine > 1000 ng/mL to confirm daily smoking (NicAlert=6)

Exclusion Criteria:

  • inability to attend all required experimental sessions
  • desire to quit smoking prior to the study quit date
  • a quit attempt resulting in greater than 3 days of abstinence in the past 30 days
  • report of significant health problems including but not restricted to (e.g. chronic hypertension, emphysema, seizure disorder, history of significant heart problems)
  • unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the study physician)
  • schizophrenia and schizoaffective disorder
  • psychiatric medication changes (e.g. new prescriptions, changes in dosages, or discontinuation of medications) in the past 3 months that was a result of negative changes in symptoms
  • use of other tobacco products or e-cigarettes more than 9 days in the past 30 days
  • current alcohol or drug abuse
  • use of illegal drugs (excluding marijuana) or drugs without a valid prescription as measured by urine drug screen
  • current use of nicotine replacement therapy or other smoking cessation treatment
  • use of Theophylline for asthma
  • presence of conditions contraindicated for nicotine replacement therapy (e.g., skin allergies)
  • previous participation in a study within the past year involving use of Spectrum cigarettes
  • systolic BP greater than or equal to 140 (participants failing for blood pressure will be allowed to rescreen once)
  • diastolic BP greater than or equal to 90 (participants failing for blood pressure will be allowed to rescreen once)
  • heart rate greater than or equal to 100 (participants failing for heart rate will be allowed to rescreen once)
  • blood alcohol level >0.0 (participants failing the blood alcohol screen will be allowed to rescreen once)
  • pregnant, trying to become pregnant, or breastfeeding
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538042


Contacts
Contact: Jennifer Stevenson, PhD 919-684-5403

Locations
United States, North Carolina
Duke Medical Center Recruiting
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Francis McClernon, Ph.D.
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Francis J McClernon, Ph.D Duke University
  More Information

Responsible Party: Francis McClernon, Ph.D., Associate Professor, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT02538042     History of Changes
Other Study ID Numbers: Pro00063247
R21DA037753 ( U.S. NIH Grant/Contract )
First Submitted: August 20, 2015
First Posted: September 2, 2015
Last Update Posted: January 27, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action