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Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation

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ClinicalTrials.gov Identifier: NCT02927847
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : June 1, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Maggie M Sweitzer, PhD, Duke University

October 6, 2016
October 7, 2016
June 1, 2018
February 1, 2017
June 2021   (Final data collection date for primary outcome measure)
  • Change in BOLD response to smoking and monetary reward [ Time Frame: baseline, week 5 ]
    Effects of BA+VLNC (vs. VLNC Only) on pre-quit changes in fMRI BOLD response to smoking and monetary reward anticipation
  • Days to Relapse [ Time Frame: weeks 6 to 13 ]
    Effects of BA+VLNC (vs. VLNC Only) on smoking cessation outcomes. Relapse is defined as return to 7 consecutive days of smoking
Same as current
Complete list of historical versions of study NCT02927847 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation
Targeting Reward Dysfunction as a Mechanism to Improve Smoking Cessation
The goal of this study is to evaluate the effects of a smoking cessation intervention combining behavioral treatment with low nicotine cigarettes on neuroimaging measures of reward function and smoking cessation outcomes. The results of this study will provide information about mechanisms contributing to smoking and smoking cessation and will help to guide future treatment studies.
Smokers who are interested in quitting will be randomly assigned to one of two treatment conditions. In the BA +VLNC condition (n = 24) smokers will switch to smoking very low nicotine cigarettes (VLNCs) while wearing a 21 mg/d nicotine patch for 5 weeks prior to their quit date. They will also participate in weekly behavioral activation (BA) treatment sessions. Smokers in the VLNC Only group (n = 24) will undergo the same pharmacological pretreatment but will undergo standard counseling and health education instead of BA. Following the quit date, both groups will receive standard nicotine replacement therapy. At baseline and pre-quit, BOLD response to smoking and non-smoking rewards will be measured using fMRI after 24 hr abstinence. Latency to relapse will serve as a continuous clinical outcome measure.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Smoking
  • Drug: Nicotine Patch
    Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).
    Other Name: Nicoderm CQ
  • Drug: SPECTRUM Nicotine Research Cigarettes (.03 mg)
    For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
    Other Name: Very Low Nicotine Content Cigarettes
  • Behavioral: Behavioral Activation
    Participants in the BA+VLNC group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of behavioral activation treatment. BA components will include activity monitoring, values assessment, activity scheduling, and social contracts.
    Other Name: BA
  • Behavioral: Supportive Counseling
    Participants in the VLNC Only group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of supportive counseling and health education. Supportive counseling and health education will include empathic listening as well as informational content on topics of exercise, nutrition, sleep and relaxation.
  • Experimental: BA + VLNC
    Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during the quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus behavioral activation therapy aimed at increasing reinforcement from non-drug rewards.
    Interventions:
    • Drug: Nicotine Patch
    • Drug: SPECTRUM Nicotine Research Cigarettes (.03 mg)
    • Behavioral: Behavioral Activation
  • Active Comparator: VLNC Only
    Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.
    Interventions:
    • Drug: Nicotine Patch
    • Drug: SPECTRUM Nicotine Research Cigarettes (.03 mg)
    • Behavioral: Supportive Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Same as current
June 2021
June 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • generally healthy
  • intact intellectual functioning (K-BIT2 >79)
  • smoking at least 5 cigarettes per day
  • expired CO concentration of at least 8 ppm or urinary cotinine > 100 ng/mL
  • interested in quitting smoking

Exclusion Criteria:

  • inability to attend all experimental sessions
  • report of significant health problems
  • use of psychoactive medications or current participation in psychotherapy
  • current unstable psychiatric illness as assessed by clinical diagnostic interview
  • suicidal ideation with plan or intent
  • regular use of smokeless tobacco
  • current alcohol or drug abuse
  • use of illegal drugs (excluding marijuana) as measured by urine drug screen
  • current use of nicotine replacement therapy or other smoking cessation treatment
  • presence of contraindications for nicotine replacement therapy
  • left-handed
  • presence of conditions that would make MRI unsafe
  • claustrophobia
  • history of fainting
  • pregnant, trying to become pregnant, or breastfeeding
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact: Kayla Hernandez, B.S. 919-684-5460 kayla.hernandez@duke.edu
United States
 
 
NCT02927847
Pro00076408
K23DA039294 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Maggie M Sweitzer, PhD, Duke University
Maggie M Sweitzer, PhD
National Institute on Drug Abuse (NIDA)
Principal Investigator: Maggie M Sweitzer, PhD Duke University
Duke University
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP