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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Drug: Nicotine Patch Drug: SPECTRUM Nicotine Research Cigarettes (.03 mg) Behavioral: Behavioral Activation Behavioral: Supportive Counseling Phase 1 Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Targeting Reward Dysfunction as a Mechanism to Improve Smoking Cessation
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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: 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.




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02927847


Contacts
Contact: Kayla Hernandez, B.S. 919-684-5460 kayla.hernandez@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Maggie Sweitzer, PhD    919-668-0094      
Sponsors and Collaborators
Maggie M Sweitzer, PhD
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Maggie M Sweitzer, PhD Duke University

Responsible Party: Maggie M Sweitzer, PhD, Assistant Professor, Duke University
ClinicalTrials.gov Identifier: NCT02927847     History of Changes
Other Study ID Numbers: Pro00076408
K23DA039294 ( U.S. NIH Grant/Contract )
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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